COMPARISON OF INTRA AND POST OPERATIVE COMPLICATIONS BETWEEN IN SITU AND EXTRA ABDOMINAL UTERINE REPAIR AT CESAREAN DELIVERY INTRODUCTION: Cesarean section has been a mode of delivery since ages. It is the most significant obstetric intervention that has saved countless number of mothers and infants. Numerous references to cesarean section have been made in ancient Indian, Egyptian, Roman, and European literature. Cesarean section has evolved very drastically and dramatically in respect to the purpose, technique, post operative care, cost effectiveness and other aspects to reduce the morbidity. Historical background: The origin of the word cesarean is unclear. It is likely that the term comes from lex regia or royal law
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COMPARISON OF INTRA AND POST OPERATIVE
COMPLICATIONS BETWEEN IN SITU AND
EXTRA ABDOMINAL UTERINE REPAIR AT
CESAREAN DELIVERY
INTRODUCTION:
Cesarean section has been a mode of delivery since ages. It is the most significant
obstetric intervention that has saved countless number of mothers and infants. Numerous
references to cesarean section have been made in ancient Indian, Egyptian, Roman, and
European literature. Cesarean section has evolved very drastically and dramatically in
respect to the purpose, technique, post operative care, cost effectiveness and other aspects
to reduce the morbidity.
Historical background:
The origin of the word cesarean is unclear. It is likely that the term comes from
lex regia or royal law legislated from by one of the early kings of Rome, Numa
Pomphilius in 715 BC1. This law proclaimed that women who died before delivering
their infant had to have the infant removed through the abdomen before burial. This law
continued under the ruling of Caesar when it was called lex caesarea2.
During the 15th and 16th century caesarean section was carried out after the
mother’s death primarily to fulfill the religious beliefs that prevailed. The first witnessed
and documented caesarean section was performed by Jeremias Trautmann inWittenberg,
Germany in 16103.
During the 19th century classical cesarean section was widely adopted in Britain
and it gained enormous popularity and very good results. But it was Munro Kerr in 1911,
who performed the first transverse lower segment caesarean operation. Though initially
met with resistance, it was slowly accepted because of the strong reasons given by him.
He cited that lower segment was less vascular, thinned and easily approximated making
suturing easier and stronger. He also claimed that lower segment incision also had
minimal risk of rupture during subsequent pregnancies.
During caesarean section done in earlier days, patients generally died due to
hemorrhage or sepsis. After the advent of antibiotics, clean surgical practices and
improved surgical techniques these deaths were radically brought down. Introduction of
anesthesia and its massive advancement has improved maternal as well fetal outcomes
and provided pain relief for the laboring women.
Definition:
Cesarean delivery is defined as the birth of a fetus via laparotomy and then
hysterotomy4 . It can also be defined as an operative procedure whereby the fetus or
fetuses after the period of viability are delivered through an incision on the abdominal
and uterine walls5.
Statistics:
International health care community has considered the ideal rate for cesarean
sections to be between 10-15%6 . In the latest National Family Health Survey-4 (2015-16)
it is shown that the births delivered by Cesarean Section accounts to 17.2% in India as
compared to 8.5% in NFHS-3(2005-2006)7. In Tamil Nadu, births delivered by Cesarean
section during the same period have been shown to be as high as 34.1 %. In the previous
NFHS – 3 (2005-2006) births delivered by caesarean section was 20.3%. In Chennai
during the period of 2015-2016 percentage of births by caesarean section was 28.8%.
Since the last two decades, a progressive increase in caesarean delivery rates has been
observed worldwide. Maternal, obstetric, fetal, medicolegal, and social factors are pivotal
in this increment. It can be said that Cesarean section has become one of the commonly
performed surgical procedure in day to day obstetrics practice.
Classification of urgency of cesarean section:
A new classification developed based on the urgency of cesarean section was
proposed in 2000 by Lucas et al8 Prior to this classification all non elective cases posted
for cesarean section, were by default labeled as “emergency”. This led to a lot of
confusion because some cases were to be dealt with more urgency than the others. Based
on the new system, clinically significant decisions like decision – delivery interval,
choice of anesthesia etc can be made by the obstetricians and their team.
Fig Classification relating the degree of urgency to the presence or absence of fetal or maternal compromise
In category 1, decision to delivery interval can range from as soon as possible to
maximum of 30 minutes. Here there is immediate threat to the woman or the fetus when
delivery is not done. The clinical situations include prolonged fetal bradycardia, fetal
scalp pH <7.2, cord prolapse, abruptio placenta with fetal heart changes and suspected
uterine rupture.
In category 2, delivery is intended to be done within 30-45 minutes. Situations
like antepartum hemorrhage with reactive fetal heart tracing, non- progress of labor with
maternal and fetal compromise not as severe as category 1 are included in this category.
Category 3 in this classification requires early delivery but currently there is no
immediate risk to both the fetus and the mother. Non progress of labor without maternal
or fetal compromise, women scheduled for elective cesarean but presenting with ruptured
membranes or in labor non willing for trial of labor, worsening pre-eclampsia, are some
of the day to day scenarios which can be classified as category 3. It is recommended that
these women be delivered by at least 75 minutes to avoid adverse events.
Category 4 - Elective planned caesarean section that can be timed to suit the
woman and the obstetrics staff fall under this category. All cesarean section under this
category should be preferentially done after 39 completed weeks to have better neonatal
outcome in the absence of any other risk factors.
Anesthesia for caesarean section:
All women who are pregnant are potential candidates for emergency
administration of anesthesia. Those admitted for safe confinement have a great
probability for the need of anesthesia. Considering this fact, it is wise to send all high risk
pregnant women for pre anesthetic evaluation in their late second or early third trimester.
The anesthesiologist can take a focused history and physical examination that evaluates
the lungs, airway, and heart in a much more composed environment because during labor
it is very difficult to do the same. Risk and benefits of anesthetic management decisions
should be discussed on case to case basis. During the event of a caesarean delivery it is
always important to get an elaborate informed written consent for the surgery as well as
anesthesia, stating all the potential complications including aspiration, hemorrhage and
thrombo-embolism. Caesarean section carries a risk for short term postoperative
morbidity like fever, pain, hemorrhage, damage to bladder, bowel or ureters, and
thromboembolism. Long term clinical and obstetric problems include chronic pain,
infertility, bowel obstruction, abnormal placentation and its consequence.
Aspiration prophylaxis in the form of providing clear liquids after the onset of
labor, pharmacological drugs like non particulate antacids, H2 receptor antagonist,
metaclopramide, proton pump inhibitors can be used. Proper administration of the drugs
at least 30 minutes prior to cesarean section can reduce the intra operative complications
like nausea, vomiting and help in the women to have a better recovery.
It is ideal that the delivery unit and the operating room are adjacent to help in
prompt transfer of the patient during adverse events. The operating room should be well
equipped with monitors and checked regularly. Drugs used for general and neuraxial
anesthesia should be made promptly available.
Any day regional anesthesia is found to be better than general anesthesia for
obstetric patients unless there are special situations like thrombocytopenia, infections etc.
But there are certain drawbacks like inadequate blockade leading on to perception of
pain, failure to take up, multiple punctures, post Dural headache, hematoma etc.
Adequate sensory blockade up to sensory level of T4 and motor level up to T6 is
desirable to perform caesarean section9. All this being said, there are reports of cesarean
section being performed under local anesthesia; patients still doing well.
Surgical technique:
Cesarean section is delivery of the baby though an abdominal incision from an
intact uterus after the period of viability. Low transverse Pfannenstiel or Joel –Cohen
incision in made over the abdomen. Lower midline incision may be used when speed of
entry is paramount. The abdominal wall is entered in layers to reach the peritoneum,
which is opened as high as possible. Some surgeons prefer finger or blunt dissection of
the peritoneum while some prefer sharp. The uterus is checked for dextro- or laevo-
rotation. The uterovesical fold of peritoneum is identified and incision is made 2 cm
below this reflection over the lower uterine segment avoiding the bladder. The thickness
of the lower uterine segment varies depending on the gestational age, the stage and
duration of labor. When the patient is in well established labor, the lower segment is very
thin and simple nick of 1 cm will be enough to open the uterus. But when the patient is
remote from labor, this segment can be as thick as the upper segment and deeper incision
might be needed to open the uterus. The incision is then extended in cephalocaudal
direction.
The baby is extracted, umbilical cord is clamped and cut and the baby is handed
over to the pediatrician. Here again, latest consensus emphasis on the need for delayed
cord clamping when the fetus is not in distress to reduce the incidences of anemia.
In active management of third stage of labor, uterotonics are administered within
one minute following delivery. Commonly, during caesarean section Oxytocin 5 U can be
given as slow intravenous injection followed by Oxytocin 40 U in intravenous solution of
Ringer Lactate as a drip that can be left to run over three to four hours. Placenta is
spontaneously expelled. The uterus is then closed in layers, hemostasis is achieved and
abdomen is closed in layers. Single layer or double layer closure with continuous or
interlocking sutures of the uterine wound are also under dispute. Transient removal of the
uterus from the abdomen and exteriorizing it to facilitate repair of uterine incision has
been used as technique in many institutes. This has been shown to be of immense help
when the exposure of the uterine angles is difficult or with extension of the uterine
incision due to difficult delivery or thinned out lower uterine segment. Many
obstetricians prefer this method and claim that blood loss has also been shown to be
minimal due to reduction in blood flow as a result to kinking of the uterine veins.
However, opposition to this technique when the patient is under regional anesthesia has
been put forth as it leads to intra and post operative events like nausea, vomiting,
hypotension, trauma to the adnexal structures and pain which are undesirable.
Exteriorization of the uterus also has a potential risk of infections.
“There is more than one way to skin the cat” -Like for any surgical procedure, the
techniques and steps followed during cesarean section varies from one gynecologist to
the other. Though the basic principles of the surgery are the same, subtle differences in
the techniques adopted are done for the comfort of the surgeon and for the benefit of the
patient. These technical variations have been aimed at reducing the operative blood loss,
easier surgical access, length of the procedure, febrile or infectious morbidity, reducing
the days of hospital stay, decreasing adverse effects, and other events like nausea,
vomiting, pain, hypotension etc. Many surgical techniques have not been rigorously
assessed in randomized controlled trials and so whether any them are associated with
better outcome for the women and babies is not known, or rather proven scientifically.
Owing to volume of caesarean deliveries done globally, even a small difference in
morbidity between the techniques could cause huge impact on the improvement of
women’s health and their quality of life.
After observing these techniques which are practiced routinely, question arises to
which technique is superior with respect to reduced morbidity, patient’s safety, comfort
and surgeon’s preference. Hence, this study was done to identify these differences and
give the best possible care for the patient.
AIMS AND OBJECTIVES:
Primary objectives:
1. To compare intra operative pain morbidity between in situ and extra abdominal
repair in women undergoing caesarean delivery using verbal analogue scoring
scale.
2. To compare post operative fall in hemoglobin among the women undergoing
caesarean section by in situ and extra abdominal uterine repair.
Secondary objectives:
1. To compare the incidence of nausea and vomiting between the two groups during
intra operative period.
2. To compare the incidence of post operative febrile morbidity among the two
groups.
3. To compare the time taken for return of bowel functions between the two groups.
REVIEW OF LITERATURE:
Chauhan S et al10
This study was published in January 2018. It was a randomized controlled trial
done at Kerala Institute of Medical Sciences, Trivandrum. 200 pregnant patients were
randomized into two groups of 100 each. Statistical analysis of various events and
variables like mean time taken for uterine incision closure, intra operative blood loss and
post operative morbidities were done. They concluded that lesser mean time for uterine
wound repair ( P value = 0.05) was seen in exteriorized group. Post operative pain (P
value 0.025) and need for additional analgesic dose (P value = 0.034) was more in
exteriorized group. They found no significant difference in incidence of intra operative
nausea, vomiting, incidence of endomyometritis, febrile morbidity, wound infections,
time taken for return of bowel functions and length of hospital stay.
They concluded by saying that surgeon’s experience and
preference should determine the choice of uterine repair. There was no
evidence to suggest that exteriorizing the uterus has a more harmful
influence on maternal morbidity than in situ repair.
Priya L et al11
This study was published in April 2017. It was a prospective
comparative study performed at Mahatma Gandhi Medical College and
Research Institute, Pondicherry. 200 women undergoing cesarean
delivery were assigned as two groups with 100 patients in each group.
They included patients undergoing both emergency and elective
cesarean section with a term live singleton pregnancy in cephalic
presentation. They showed significant difference in blood loss P value
<0.001 and increased rate of blood transfusion P value of 0.038 in in-
situ repair group. Post operative complications like febrile morbidity
was also significant in in-situ group (P value 0.046). there were no
significance in other variables like urinary tract infection,SSI,
Endometritis and hospital stay.
V. Zaphiratos et al12
In 2015, systematic review and meta-analysis was published in Canadian Journal
of Anesthesia which included 16 randomized controlled trials and results were discussed.
In total, 9,736 subjects underwent extra abdominal and 9,703 had in situ uterine repair.
The primary outcomes and the results are as follows:
S.No Primary outcome Results
1 Reduction in haemoglobin
Six studies including 7,585 patients reported
a reduction in haemoglobin data. Pooled
results showed statistically significant drop
in haemoglobin higher in in-situ group.
(Mean difference,-0.14 g_dL-1; 95%
CI, -0.22 to -0.07).
2 Blood transfusion
Ten studies including 17,568 patients did not
show any significant difference.
3 Estimated blood loss Pooled data from six studies (908 patients)
showed no statistically significant difference
between the two repair techniques. (mean
difference [MD], -61.03 mL; 95%
confidence interval [CI], -127.34 to
5.28);
4 Intra operative nausea and
vomiting
Five studies were analysed and no
significant difference was identified. (odds
ratio [OR], 0.99; 95% CI, 0.74 to
1.34)
5 Intra operative pain Three studies( 439 patient)s pooled results
were analysed and showed no difference.
(OR, 1.52; 95%
CI, 0.86 to 2.71)
The secondary and additional outcomes studied were:
S.No Outcomes Results
1 Return of bowel function Four studies including 6,473 patients were
analysed and three out of the four studies
strongly favoured in situ repair. (MD, 3.09
hr; 95% CI, 2.21 to 3.97)
2 Endometritis (sensitivity
analysis)
17,600 patients over a span of eight studies
were compared and in situ repair was found
to be slightly advantageous over the extra
abdominal repair of uterus. (OR, 1.25;
95% CI, 0.96 to 1.62)
3 Wound infection (sensitivity
analysis)
Nine studies including 17,188 patients
showed no significant difference between
the two groups.
4 Operative time Thirteen studies were analysed and no
statistically significant results were arrived.
5 Hospital stay Nine studied showing 17,161 patients were
compared and found to have no statistically
significant difference between the two
techniques
6 Fever No significant difference was noted in five
studies that included 10,610 patients.
The studies included are as follows :
I. El-Khayat et al13
This study was published in June 2014. It was a double
blinded randomized controlled trial conducted in Egypt. During the
year of 2012-2013, 1000 participants undergoing cesarean section
were recruited. They clearly concluded that in situ repair of the uterine
wound is better than it’s extra abdominal counterpart in terms of
lesser duration of surgery(49.9 ± 2.3 minutes vs 39.9 ± 1.8 minutes; P < 0.001),
reduced pain morbidity(165 [33.0%] vs 115 [23.0%]; P = 0.001) and faster return of
bowel functions(17.0 ± 2.7 hours vs 14.0 ± 1.9 hours; P < 0.001).
II. Abalos et al14
Popularly called as the CORONIS (caesarean section surgical techniques)
collaborative group, Abalos et al published their 2X2X2X2X2 fractional, factorial
randomized controlled trial in Lancet 2013.It was international study done in 19 sites
including India. Each site was assigned three of the five intervention pairs: blunt versus
sharp abdominal entry; exteriorization versus in-situ repair of the uterus; single versus
double layer closure of the uterus, closure versus non—closure of the peritoneum,
chromic catgut versus polyglactin-910 for uterine repair. Total of 15,935 women were
recruited for the study. Eligibility criteria were any women undergoing caesarean section
through a transverse incision irrespective of fever, gestational age, or multiple
pregnancies. The primary outcome was the composite of death (<0.1% in in situ and
0.1% in exteriorized RR 0.25%), maternal infectious morbidity(1% in in situ and 1% in
exteriorized RR 1.06), further operative procedures(2%in in situ and 2% in exteriorized
RR 1.04)or blood transfusion( 1.5% in in situ and 1.5% in exteriorized RR1.04) . There
was no statistically significant difference in any of the primary outcomes they measured.
They suggested that any of these techniques were acceptable, but whether absence of
short term adverse effects will translate into absence of long term consequences need to
be studied.
III. Ozbay et al15
A total of 338 patients who were randomized as 171 in extra
abdominal group and 167 as in-situ repair group were included in this
study. It was published in 2011. They compared variables like blood
loss, febrile morbidity, postoperative analgesic dosage, and incidence
of post operative nausea and vomiting. They concluded that both the
techniques were valid options during cesarean section but the surgery took a lesser time
and shorter length of hospital stay when the uterine repair was done in-situ (30.64 +/-
8.65 vs 33.02 +/- 9.54 min., p = 0.011 and 2.23 +/- 0.49 vs 2.45 +/- 0.94 days, p = 0.045).
IV. Dog˘anay et al16
In 2010, a large prospective randomized controlled trial done by
Dog˘anay et al. Objective of this study was comparing the rates of
intra and post operative complications of uterine repair when
performed extra abdominally or in-situ. 4925 participated in the study
and variables like drop in hemoglobin concentration, operative time,
return of bowel sound, duration of hospitalization, rates of uterine
atony, need for blood transfusion, intra operative complications,
endometritis, wound infection were analyzed. They concluded that with
in-situ repair there were fewer instances of uterine atony(3.8% in situ
group and 9.1% in extra abdominal group; p=0.001) , faster return of
bowel functions, lesser need for analgesia and reduced incidence of
wound infections( p =0.001,p=0.002,p=0.003,respectively).
V. Coutinho et al17
This study was conducted in Brazil and published in Obstetrics and Gynecology
(Green journal) in 2008. It was a randomized controlled trial with 637 participants.
Variables analyzed were nausea, vomiting, mean operative time, intra operative blood
loss, number of surgical sutures for uterine repair, postoperative pain, number of post
operative analgesic doses, surgical site infections, and endometritis. A significant
difference was noted in the operative time 44% with exteriorized uterus compared with
35.3% with in situ uterus) which was found to be shorter in exteriorized group and less
suture material (18.2% requiring one suture in the exteriorized group compared with
11.9% in the in situ group, P=.03) was needed for uterine repair. However, moderate to
severe pain after 6 hours was noted in the same group (23.1%) when compared to those
who had in-situ(32.6%) repair. There were no other noteworthy differences in relation to
the other variables compared.
VI. Orji et al18
This study was published in 2008 in the Australian and New
Zealand Journal of Obstetrics and Gynecology. It was done to assess
the intra operative and postoperative morbidity following extra
abdominal repair of the uterus at caesarean section as compared to
those with non- exteriorization. 210 participants were recruited. Their
results showed significant reduction in intra operative blood loss
(p<0.05), number of analgesic dose(p<0.05), and duration of hospital
stay(p<0.05) in uterine exteriorized group but return of bowel function
was slightly longer.
VII. Siddiqui et al19
In 2007, a randomized single blinded controlled trial was published
in the Green Journal, where 80 women undergoing elective cesarean
section under spinal anesthesia were studied. In this study assisted
delivery of placenta, spinal anesthesia and oxytocin management
protocols were standardized. The primary outcome observed was post
operative nausea or vomiting. They concluded that exteriorization of
uterus was associated with significant increase in the incidence of
nausea or vomiting (18% compared with 38%; P=0.04) and
tachycardia (3% compared to 18%; P=0.03) during cesarean delivery
under spinal anesthesia. They further went on to say that wherever
possible in-situ repair of the uterus must tried.
VIII. Nafisi et al20
This study was done to compare post cesarean pain associated with
routine exteriorization of the uterus and in situ repair. It was a
prospective randomized control trial published in 2007 including 206
women who underwent cesarean delivery under general anesthesia.
They concluded that exteriorization was associated with increased post
operative pain in the first and second post operative day (66.7 vs. 43.5 (P <
0.001); 44.6 vs. 23.9 (P < 0.001 respectively).
IX. Baksu et al21
This randomized controlled trial was published in February 2005 in Acta
Obstetrcia et Gynecologica Scandinavica. The purpose of the study was to determine
whether method of placental removal and site of uterine repair made any significant
difference in post operative endometritis and blood loss. 840 women who underwent
caesarean section were recruited into 4 groups. Patients who received intra partum
antibiotics, had chorioamnionitis, required emergency hysterectomy , rupture of
membranes more than 12 hours, abnormal placentation, prior postpartum hemorrhage,
bleeding diathesis were excluded. The study concluded that manual removal of placenta
at caesarean delivery resulted in more significant blood loss and occurrence of
endometritis( 15.2% in manual removal and 5.7% in spontaneous with p<0.05). The site
of uterine repair did not show any statistically significant discrepancy.
X. Ezechi et al22
They compared 136 women undergoing primary caesarean section at Nigeria
and published their findings in 2005. They concluded that operative time, estimated blood
loss, transfusion rate and postoperative anemia rate were significantly less in the
exteriorized group than the intra peritoneal group (p= 0.000, 0.009,0.048 0.038and 0.028
respectively). Exteriorization of the uterus is a preferred technique of uterine
wound closure except where it is not impossible because of adhesions
or surgeons inexperience.
XI. Wahab et al23
This prospective randomized controlled trial was published in 1999 in British
Journal of Obstetrics and Gynecology. 316 women were randomized. They gave an
important conclusion that with effective anesthesia, exteriorization of the uterus for repair
was not associated with significant blood loss or increased pain (P< 0.05). Hence, during
an emergency, surgeons need not be reluctant in exteriorizing the uterus for repair.
XII. Edi-Osagie et al24
This was also a randomized controlled trial published in 1998.
194 participants were randomized as 100 in extra abdominal group
and 94 in in-situ group. The variables compared were intra operative
pulse rate, mean arterial blood pressure and oxygen saturation,
hemoglobin concentration, incidence of intra operative vomiting, pain,
intra- and postoperative complications, febrile and infectious morbidity,
immediate and late puerperal pain, satisfaction post surgery. 57% of all pain complaints
occurred at the initial skin incision, 14% at incision of the rectus sheath, and 29% on
uterine exteriorization. These data suggest the occurrence of pain depended more on the
adequacy of anesthesia utilized for surgery, than the individual techniques of the
operation. They found no evidence that exteriorization of the uterus at cesarean had a
harmful influence on maternal morbidity than in situ repair. Providing
adequate anesthesia for women undergoing cesarean section are
paramount and universal anti-emetics policy needs to be advised to
reduce risk of vomiting, thereby reducing the risk of aspiration.
XIII. Magann et al25
The same set of investigators published a larger trial in 1995 with
284 participants to compare the infectious morbidity. They concluded
that manual removal of placenta and exteriorization of the uterus for
repair increase the infectious morbidity when the women received
prophylactic antibiotics.
XIV. Magann et al26
In 1993, Magann et al conducted a randomized controlled trial to
compare the blood loss with two methods of placental removal and site
of uterine repair. They concluded that it was the method of placental
removal and not the position of the uterus at the time of repair had a
significant role in blood loss during cesarean section.
XV. Magann et al27
In the same year, Magann et al published another study in
Infectious diseases in obstetrics and Gynecology were they compared
the infectious morbidity arising due to the different techniques of
uterine repair and type of placental removal. They concluded that
endometritis was more in manual removal of placenta with
exteriorization of the uterus when all the other known causes of
infectious morbidity was constant.
XVI. Hershey et al28
This study was done in 1978 at Los Angeles – University of Southern
California Medical center were 386 consecutive cesarean sections were
randomized and analyzed. Their results favored exteriorization of the
uterus except for vomiting (3.4%) which was lesser in in-situ repair
group.
Thus, this systematic review and meta-analysis computed various
outcomes that were studied and gave a comprehensive report. But
there are certain limitations like no study in this analysis had all the
primary outcomes defined in the review, nausea, vomiting, pain and
hemodynamic instability with exteriorization was reported in only few
studies and different post operative analgesia regimens were used in
different studies. Blood loss estimation was not standardized in many
studies. Finally, several outcomes discussed here can be influenced by
many confounding variables like emergency or elective cesarean
section, length of labor, rupture of membranes, type of anesthesia, use
and timing of antibiotics, use of vasopressor agents, and post
operative analgesia regimen.
They concluded by saying that ideal technique of uterine repair for
cesarean delivery is still under debate. Variables like blood loss, intra
operative nausea, vomiting, or pain showed no statistically significant
difference. In situ repair may be associated with faster return of bowel
function. Well conducted randomized control trials are need to focus on
intra operative events like nausea, vomiting or pain.
Shuja et al29
This was a randomized control trial done during the period of 2012-2013 at
Combined Military Hospital, Quetta. It was published in 2015. Here 780 patients (390 in
each group) were recruited for the study and many significant conclusions were made.
Inclusion criteria: elective cesarean deliveries, parity 2 or more with singleton pregnancy
at term assessed by dating scan. They showed results reinforcing the concept of in-situ
repair stating that exteriorization of the uterus was accompanied with increase in pain and
vomiting (18%in in situ repair group and 38% in exteriorization group ;p< 0.001) and
also increased operative time. The only advantage of exteriorization of uterus was found
to be good surgical exposure and access to uterine angles better.
4. Uzma Yaqub et al30
This was a randomized control trial done and published in 2012 at Lahore,
Pakistan. 100 patients were randomized. Only Primi gravidas were included in the study.
U one-sided percentage point of the normal distribution corresponding to 100
% – the power (For 80% power u =0.84 )
V Percentage point of the normal distribution corresponding to the (two-sided)
significance level (for significance level = 5%, v = 1.96)
In my study 170 participants were recruited and met the criteria. Informed
consent was obtained from all.
METHODOLOGY:
The study will be Randomized single blind controlled trial
Randomization:
Participants will be allocated to each of the study groups using random number
tables from a standard statistical text book. Numerical sequence for each of the
intervention will be laid down before random sequence generation ( For example: odd
numbers from 1-9 for intervention A and Even numbers for intervention B)
Allocation concealment:
Random sequence generated will be kept in serially numbered opaque sealed
envelope in the custody of an independent statistician or faculty, who is not part of the
primary research team. After recruiting each participant, the corresponding numbered
envelop will be opened and the participant will be allotted to the particular intervention
Blinding:
The investigator blinding is not possible, considering the nature of intervention.
The participants and the statistician analyzing the data will be blinded for the
intervention.
STATISTICAL METHODS:
Intra and post operative pain and fall in hemoglobin levels were considered as primary
outcome variables.
Secondary outcome variables: Nausea or vomiting, return of bowel function, and febrile
morbidity
Technique of LSCS was considered as primary explanatory variable.
Normality tests for quantitative variables:
A shapiro- wilk’s test (p>0.05) and a visual inspection of their histograms, normal
Q-Q plots and box plots showed that the duration of surgery, fall in haemoglobin, Verbal
analog score for pain, return of bowel function parameters were non-normally distributed
for technique of LSCS.
Descriptive analysis of quantitative variables was carried out by mean and
standard deviation for normally distributed variables and median, inter quartile range for
non-normally distributed variables. Categorical variables were summarized by frequency
and proportion.
The comparison between technique of LSCS and duration of surgery, fall in
haemoglobin, Verbal analog score, return of bowel function parameters were assessed by
comparing the median values. Mann Whitney U test was used to assess statistical
significance. Data was also represented using appropriate diagram like comparative box
plots.
The association between technique of LSCS, PPH and type of cesarean delivery,
intra operative and post operative pain, intra and post operative NV, post-operative
febrile morbidity were assessed by cross tabulation and comparison of percentages. Chi
square test was used to test statistical significance. Data was also represented using
appropriate diagram like clustered bar chart.
P value < 0.05 was considered statistically significant. IBM SPSS version 22 was
used for statistical analysis.
All pregnant women undergoing lower segment cesarean delivery (category 3
and 4) at Southern Railway HQ hospital, Chennai who had given a written informed
consent for participating in the study are listed. In our institution, both extra abdominal
and in-situ repair of the uterine incision has been done by the consultants depending on
the their level of comfort. In the event of a cesarean delivery, type of repair, operative
time from the start of skin incision to the closure of the skin wound and the intra and post
operative complications was observed and recorded in the operative notes and the same
was used to complete the proforma of every participant.
All patients received metoclopramide injection (0.25mg/kg body weight) and
ranitidine injection (2mg/kg maximum of 50mg) intravenously 30 minutes prior to the
surgery. The baseline readings of noninvasive blood pressure, heart rate, and SpO2 were
taken two times, 5 minutes apart, in the preoperative holding area, where an large bore
intravenous line (16 or 18 gauge) was established and lactated Ringer’s solution started to
keep the vein open.
Patients were randomly assigned by means of a computer-generated
randomization scheme into one of the two study groups: extra abdominal repair or in situ
repair in the maternity unit prior to their arrival to the operating theatre . Spinal
anesthesia by “single shot” technique was performed in the sitting position or lateral
position, using a 25,26 or 27-gauge Quincke needle depending on the patient, with 7.5
mg – 15 mg of 0.5%hyperbaric bupivacaine, depending on the height of the patient. E
technique was performed at the L3 to L4 interspace or lower. After the spinal injection,
patients were immediately placed in the supine position with slight left tilt. Supplemental
oxygen via nasal oxygen mask was administered at a rate of 4 L/min until delivery of the
infant. A sensory block to T4 is checked by pin prick prior to incision. Motor blockade up
to T6 is achieved. Patients were informed that they may be aware of surgical
manipulations during the procedure but perception of pain will not be present. Any
concerns were encouraged to be informed immediately. Two gram of cefazolin injection
diluted in 10 mL of normal saline was given as the first choice antibiotic given 15
minutes prior to incision.
Pfannelsteil incision was the skin incision used and abdomen was entered either
bluntly or by sharp dissection of the peritoneum. Uterovesical fold of peritoneum was
identified and Kerr’s incision was given over the lower uterine segment and baby was
delivered. After the delivery of the infant, all patients received a bolus of 5 Units of
oxytocin injection intravenously, followed by an infusion of 40 Units diluted in 500 mL
of lactated Ringer’s at a rate of 200ml/hr . Incremental bolus doses of 5 units can be
given at the surgeons’ request. If the surgeon demands extra uterotonics, they were given
and made a special mention in the operative notes. Spontaneous delivery of the placenta
was done and appropriate contraction of the uterus was achieved before exteriorization,
incase patients were randomly assigned to do so. Blood pressure was assessed every
minute throughout the cesarean delivery. Any drop in blood pressure was treated with an
intravenous bolus dose of 6mg of Ephedrine, repeated as necessary, to maintain systolic
blood pressure within 10% of the baseline values. Phenylephrine was used as a second
choice as per institution protocol. Hypotension was defined as a decrease in systolic
blood pressure greater than 20% of the baseline value, despite the use of prophylactic
ephedrine. In the event of discomfort requiring analgesic supplementation, the patients
can be given up to 50-100 mcg of Fentanyl intravenously. Intraoperative notes were used
to fill the detailed proforma available for each patient regarding other significant events
like Adhesiolysis, Postpartum hemorrhage etc.
The patients were questioned intra operatively at specific intervals and records
kept of any nausea, vomiting, or pain. Pain was quantified with a verbal numerical rating
scale of 0 to 10 (0 being no pain and10 being worst pain imaginable). Uterus exteriorized
was to be placed over a clean wet mop to prevent desiccation. Uterine repair in our
institution is done in two layers with No 1 polyglactin suture material. Sterilization (if the
patient has given consent) was done using chromic catgut by modified Pomeroy’s
technique. Peritoneum is routinely closed using No 2-0 polyglactin suture material.
Rectus sheath is then closed with continuous sutures of No 1-0 monofilament nylon
sutures. Skin is closed with 4-5 mattress sutures using No 2-0 monofilament nylon. The
total duration of surgery (skin incision to skin suture) was noted. Immediately before and
after surgery, the level of anesthetic block was checked bilaterally by pinprick and
recorded. Diclofenac Sodium suppositories were administered rectally at the end of the
surgery as an adjunct to postoperative analgesia. If patients requested for additional
analgesia injection tramadol 50-100 mg was given intramuscularly. Need for additional
analgesia was noted in the proforma. Patients were observed for 24 hours in the post
operative care unit. The oxytocin infusion was continued at the rate of 40 milli-Units/min
for 4 hours. Hemoglobin was recorded before surgery and within 24- 72 hours after
surgery. Postoperatively after 3-6 hours following the surgery once again patients were
enquired regarding nausea, vomiting, uneasiness, pain etc. Return of bowel function was
checked every three hours by auscultation for bowel sounds and patients were also
enquired regarding passage of flatus. Liquid diet on the return of bowel sounds was
started.
Postoperative wound dressings were changed on post operative day 3.
Temperature, BP chart was maintained and wound was checked for induration, discharge
and pain. Suture removal was done generally 7 days post operative or depending of the
wound. Patients are to be followed up for 6 weeks in the post natal clinic for wound
infections.
Febrile morbidity is defined as temperature of 38.C(100.4.F)or greater recorded
on two separate occasions, atleast 6 hours apart, more than 24 hours after the surgical
procedure. It is important to recognize that all febrile morbidity is not infectious
morbidity. It is important to treat the infection and not just the fever. In case of post
operative fever, patients were examined for lung infections, UTI, thrombophebitis or
wound infections. Category 3 and 4 Cesarean section wounds are generally clean or clean
contaminated wounds. There can be development of organ/space surgical site infections
or superficial/deep incision infections. These are characterized by presence of erythema,
warmth, tendernesss, swelling, seroma or purulent discharge from the wound site (wound
cellulitis) or presence of necrosis (deep wound infections).
Puerperal infections are associated with fevers spiking within the first 24 hours
after giving birth. These may be caused by preexisting genital tract infections. Other
causes of puerperal fever includes breast engorgement, urinary tract infections,
episiotomy and abdominal infections, perineal lacerations, hematoma, respiratory
complications.* Postpartum uterine infections are variedly called as endometritis,
endomyometritis and endoparametritis. Route of delivery is the single most significant
risk factor for development of uterine infections. Puerperal infections following cesarean
delivery is most commonly due to primarily infected surgical site. Microorganisms that
colonise the cervix and vagina gain access to the amniotic fluid and invade the
devitalized uterine tissue leading to infection. Clinical features include fever, abdominal
pain, parametrial tenderness, leucocytosis, foul smelling lochia, sub involution of uterus.
Due to overlapping definitions, in my study both surgical site infections as well as
puerperal sepsis has been included under variable as febrile morbidity. Patients are
followed up to six weeks for any of the above mentioned clinical features and treated
with appropriate antibiotics for the same.
OBSERVATION AND RESULTS:
A total of 174 subjects were recruited for the study but 4 patients intraoperatively had complications like dense adhesions, need for surgical management for PPH and hence excluded. Finally, the study was conducted with 170 subjects and the following analysis were done.
AGE DISTRIBUTION:
Table 1: Descriptive analysis of age (in years) in study population (N=170)
Parameter Mean ± SD Median Min Max 95% C.ILower Upper
Age (in years) 26.49 ± 4.11 26.00 19.00 39.00 25.87 27.12
The mean age was 26.49 ± 4.11in the study population. Ranged between was 19 years to
39 years(95% CI 25.87to 27.12). (Table 1)
GESTATIONAL AGE:
Table 2: Descriptive analysis of Gestational age (in weeks) in study population (N=170)
Parameter Mean ± SD Median Min Max 95% C.ILower Upper
Gestational age (in weeks) 38.63 ± 0.91 38.43 37.14 41.00 38.49 38.76
The mean gestational age (in weeks) was 38.63 ± 0.91in the study population. Ranged
between was 37.14 weeks to 41 weeks (95% CI 38.49to 38.76). (Table 2)
TYPE OF CAESAREAN:
Table 3: Descriptive analysis of type of Caesarean in study population (N=170)
Type of Caesarean Frequency PercentagesRepeat Caesarean 105 61.80%
Primary 65 38.20%
Among the study population, 105 (61.80%) women had repeat cesarean and 65 (38.20%)
women had primary cesarean. (Table 3 & Figure 1)
Figure 1: Pie chart of type of cesarean in study population (N=170)
61.80%
38.20%Repeat CesareanPrimary
Table 23: Comparison of technique of LSCS with type of Caesarean (N=170)
Type of Caesarean
Technique of LSCSChi square
P-value
Insitu (N=87) Extra abdominal (N=83)
Repeat Caesarean 54 (62.1%) 51 (61.4%)
0.007 0.933Primary 33 (37.9%) 32 (38.6%)
In in situ group, 54 (62.1%) women had repeat caesarean and 33 (37.9%) women had
primary caesarean. In extra abdominal group, 51 (61.4%) women participants repeat
caesarean and 32 (38.6%) women participants had primary caesarean. The difference in
the proportion of type of caesarean between technique of LSCS was statistically not
significant (P value 0.933) (Table 23)
TECHNIQUE OF UTERINE WOUND CLOSURE:
Table 4: Descriptive analysis of Technique of LSCS in study population (N=170)
Technique of LSCS Frequency PercentagesInsitu 87 51.20%Extra abdominal 83 48.80%
Among the study population, 87 (51.20%) women had in situ of LSCS and 83 (48.80%)
women had extra abdominal of LSCS. (Table 4& Figure 2)
Figure 2: Bar chart of technique of LSCS in study population (N=170)
In situ Extra abdominal 47.50%
48.00%
48.50%
49.00%
49.50%
50.00%
50.50%
51.00%
51.50% 51.20%
48.80%
Technique of LSCS
Perc
enta
ge
INTRAOPERATIVE COMPLICATIONS:
Table 5: Descriptive analysis of extension of uterine wound in study population (N=170)
Extension of uterine wound Frequency Percentages
Yes 20 11.80%No 150 88.20%
Among the study population, 20 (11.80%) participants had extension of uterine wound. (Table 5)
Table 6: Descriptive analysis of adhesions in study population (N=170)
Adhesions Frequency PercentagesYes 18 10.60%No 152 89.40%
Among the study population, 18 (10.60%) participants had adhesions. (Table 6)
Both extension of uterine incision and presence of adhesion are significant
challenges encounter during caesarean section.
Table 7: Descriptive analysis of intra operative pain in study population (N=170)
Intra operative pain Frequency PercentagesYes 36 21.20%No 134 78.80%
Among the study population, 36 (21.20%) participants had intra operative pain. (Table 7)
Table 8: Descriptive analysis of intra operative Nausea or Vomiting in study population (N=170)
Intra operative Nausea or Vomiting Frequency Percentages
Yes 38 22.40%No 132 77.60%
Among the study population, 38 (22.40%) participants had intra operative Nausea or vomiting. (Table 8)
Since, C sections done in this study were under regional (i.e) spinal anesthesia, all
our participants are fully conscious during the procedure. Adequency of sensory blockade
up to T4 level and motor blockade of T6 were checked before and after the procedure and
patients were given universal anti emetics prophylaxis.
Table 9: Descriptive analysis of PPH in study population (N=170)
PPH Frequency PercentagesYes 22 12.90%No 148 87.10%
Among the study population, 22 (12.90%) participants had PPH. (Table 9)
Post partum haemorrhage is a dreaded complication in obstetrics. During
caesarean section an average of 1000ml of blood loss is expected. But current definition
of PPH according to ACOG is cumulative blood loss greater than or equal to 1000ml or
any amount of blood loss accompanied by signs or symptoms of hypovolemia within 24
hours after birth process including intra partum loss regardless of route of delivery. In
this study PPH was made by subjective assumption of the surgeon and their team.
Though objective assessment of hemorrhage is more scientific, it is more labourious,
difficult and not cost effective. Measurement of blood loss through assessment of mops,
suction apparatus, surgical drapes always tends to under estimate the amount of loss. For
our study we could not procure standardised mops, drapes due to budget constraints.
Most of morbidity and mortality due to PPH is “too little done too late”.
Commonest causes for PPH can be classified as 4T’s: Tone, Trauma,
Tissue,Thrombosis. Atonicity is the single most important cause for PPH. Drugs like
Prostaglandin E1, F2alpha, Ergometerine are now available which should be used wisely
during PPH management to tackle atonicity. But these drugs have side effects like
nausea, vomiting, loose stools, intra operative and post operative changes in
hemodynamics which can alter the findings of this study.
Table 10: Comparison of PPH with intra operative nausea or vomiting (N=170)
Intra operative Nausea or vomiting
PPHChi square P-value
Yes (N=22) No (N=148)Yes 7 (31.8%) 31 (20.9%)
1.304 0.253No 15 (68.2%) 117 (79.1%)
Out of 22 people with PPH, 7 (31.8%) people had intra operative nausea or
vomiting. The difference in the proportion of intra operative nausea or vomiting between
PPH was statistically not significant (P value 0.253) (Table 10& Figure 3)
Figure 3: Clustered bar chart of comparison of PPH with intra operative nausea or vomiting (N=170)
PPH Yes PPH No 0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
90.00%
31.80%
20.90%
68.20%
79.10%
Intra operative NV Yes Intra operative NV No
Perc
enta
ge
Table 19: Descriptive analysis of Duration of Surgery in study population (N=170)
Parameter Median Interquartile rangeDuration of Surgery 45.00 (35,45)
The median duration of surgery was 45 minutes (IQR 35 to 45 minutes).(Table 19)
POST OPERATIVE COMPLICATIONS:
Table 12: Descriptive analysis of haemoglobin status (%)in study population (N=170)
Parameter Mean ± SD Median Min Max 95% C.ILower Upper