Use of a uniconcave balloon in emergency cerclage Ga-Hyun Son, MD; Kylie Hae-Jin Chang, MD; Ji-Eun Song, MD; Keun-Young Lee, MD, PhD Problem: bulging fetal membranes Cervical insufficiency with bulging fetal membranes during the second trimester is a serious complication of pregnancy, leading to stillbirth or preterm delivery. 1 Women who present with advanced cervical dilation on physical examina- tion may benefit from emergency cerc- lage. 2-8 However, membranes are easily ruptured intraoperatively, especially when the cervix is widely dilated and the fetal membranes are prolapsed beyond the external os. 5,6 Pushing bulging fetal membranes back into the uterine cavity during cerclage with a sponge swab or Foley catheter is difficult. Overfilling the urinary bladder to reduce prolapsed fetal membranes without direct mechanical contact is often not sufficient as a single method. 9 Other less utilized techniques include inflatable devices, such as a metreurynter or a rubber balloon. 6-8 Our solution We designed a new uniconcave balloon device for repositioning fetal mem- branes into the uterus and report its use in 103 patients who underwent emer- gency cervical cerclage for bulging membranes from March 2010 through March 2013 at Hallym University Med- ical Center (Video Clip). Women had internal cervical os dilation at least 1 cm, with membranes visible at or beyond the external os by speculum examination. We excluded women who had multifetal gestations, fetuses with major malfor- mations, ruptured membranes, vaginal bleeding, persistent regular uterine contractions, clinical chorioamnionitis, or prior prophylactic cerclage. The study was approved by the ethics committee of our hospital. The uniconcave balloon is shown in Figure 1. In comparison with other balloon devices, the shape of our balloon is uniconcave, so that it can push the bulging amniotic sac in adjustment to its spherical shape, allowing the fetal membranes to be placed back into the uterus safely and effectively. It has a shape similar to that of a red blood cell or a donut, which provides maximum surface area to allow the force exerted on the membranes to be evenly distributed. This causes less trauma and decreases the likelihood of rupturing the membranes. The firm shaft allows physician to grip the device with one hand, leaving the other hand entirely free and convenient to suture the cervix. The shaft also has centimeter gradations marked on it to indicate the insertion depth during the procedure. Since we have various sizes of the balloon, we can choose the appro- priate size according to degree of cervical dilation. The procedure (Figure 2) was per- formed under general anesthesia in the Trendelenburg position. Transabdominal amniocentesis was performed under ul- trasonographic guidance to reduce the amount of amniotic fluid. The fetal membrane and the cervix were exposed using 2 Simpson retractors (Figure 2, A, and Figure 3, A), and the cervical edges were gently grasped with 2 atraumatic forceps (Figure 2, B). While the cervix was retracted using the forceps, the uni- concave inflated balloon was advanced via the cervical canal to push the bulging membranes back into the uterine cavity (Figure 2, C, and Figure 3, B). A McDo- nald cervical cerclage was then performed over the shaft: 1 purse-string suture with a 5-mm polyester tape was placed (Figure 2, D, and Figure 3, C). The balloon was then deflated, and the purse- string suture was tied as the instrument was withdrawn from the cervix (Figure 2, E, and Figure 3, D). All patients were given cephalosporin intravenously in the operating room. After the surgery, the patients were treated with bed rest and continued tocolysis for 3 days. The pro- cedure was defined as successful when the internal cervical os was closed with intact membranes replaced into the uterus. During the 3-year study period we performed 103 emergency cervical cerclages with the uniconcave balloon device. Of the 103 women, 12 were excluded. Eleven patients did not have complete medical records, and 1 fetus had a major cardiac anomaly. Table 1 shows the patients’ characteristics. The mean gestational age at cerclage place- ment was 21.4 2.5 weeks. Cervical dilation ranged from 1e10 cm. The pregnancy outcomes are described in Table 2. Of the 91 patients, 23 (25.3%) delivered <24 weeks’ gestation and 34 (37.4%) delivered 32 weeks. The mean gestational age at delivery was 29.4 6.7 From the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Hallym University College of Medicine, Kangnam Sacred Heart Hospital, Seoul, Korea. Industry Academic Cooperation Foundation of Hallym University holds a patent in Korea on the balloon device, with K-Y.L as an inventor. Corresponding author: Keun-Young Lee, MD, PhD. [email protected] 0002-9378/$36.00 ª 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ajog.2014.07.022 Click Supplementary Content under the article title in the online Table of Contents Pushing bulging fetal membranes back into the uterine cavity effectively without rupture of fetal membranes during emergency cerclage is a concern to obstetricians. We have developed a new uniconcave balloon device for repositioning fetal membranes into the uterus during emergency cerclage. Our technique can be accomplished easily with few complications. Key words: cervical insufficiency, emergency cerclage, uniconcave balloon Cite this article as: Son GH, Chang KH, Song JE, et al. Use of a uniconcave balloon in emergency cerclage. Am J Obstet Gynecol 2015;212:114.e1-4. 114.e1 American Journal of Obstetrics & Gynecology JANUARY 2015 Surgeon’s Corner ajog.org
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Surgeon’s Corner ajog.org
Use of a uniconcave balloon in emergency cerclageGa-Hyun Son, MD; Kylie Hae-Jin Chang, MD; Ji-Eun Song, MD; Keun-Young Lee, MD, PhD
Pushing bulging fetal membranes back into the uterine cavity effectively without ruptureof fetal membranes during emergency cerclage is a concern to obstetricians. We havedeveloped a new uniconcave balloon device for repositioning fetal membranes into theuterus during emergency cerclage. Our technique can be accomplished easily with fewcomplications.
Key words: cervical insufficiency, emergency cerclage, uniconcave balloon
Cite this article as: Son GH, Chang KH, Song JE, et al. Use of a uniconcave balloon in emergencycerclage. Am J Obstet Gynecol 2015;212:114.e1-4.
Problem: bulging fetal membranesCervical insufficiency with bulging fetalmembranes during the second trimesteris a serious complication of pregnancy,leading to stillbirth or preterm delivery.1
Women who present with advancedcervical dilation on physical examina-tion may benefit from emergency cerc-lage.2-8 However, membranes are easilyruptured intraoperatively, especiallywhen the cervix is widely dilated and thefetal membranes are prolapsed beyondthe external os.5,6 Pushing bulging fetalmembranes back into the uterine cavityduring cerclage with a sponge swab orFoley catheter is difficult. Overfilling theurinary bladder to reduce prolapsed fetalmembranes without direct mechanicalcontact is often not sufficient as a singlemethod.9 Other less utilized techniquesinclude inflatable devices, such as ametreurynter or a rubber balloon.6-8
From the Division of Maternal-Fetal Medicine,Department of Obstetrics and Gynecology,HallymUniversity College of Medicine, KangnamSacred Heart Hospital, Seoul, Korea.
Industry Academic Cooperation Foundation ofHallym University holds a patent in Korea on theballoon device, with K-Y.L as an inventor.
Corresponding author: Keun-Young Lee, MD,PhD. [email protected]
0002-9378/$36.00ª 2015 Elsevier Inc. All rights reserved.http://dx.doi.org/10.1016/j.ajog.2014.07.022
Click Supplementary Content under thearticle title in the online Table ofContents
114.e1 American Journal of Obstetrics & Gynecol
Our solutionWe designed a new uniconcave balloondevice for repositioning fetal mem-branes into the uterus and report its usein 103 patients who underwent emer-gency cervical cerclage for bulgingmembranes from March 2010 throughMarch 2013 at Hallym University Med-ical Center (Video Clip). Women hadinternal cervical os dilation at least 1 cm,with membranes visible at or beyond theexternal os by speculum examination.We excluded women who had multifetalgestations, fetuses with major malfor-mations, ruptured membranes, vaginalbleeding, persistent regular uterinecontractions, clinical chorioamnionitis,or prior prophylactic cerclage. The studywas approved by the ethics committee ofour hospital.The uniconcave balloon is shown in
Figure 1. In comparison with otherballoon devices, the shape of our balloonis uniconcave, so that it can push thebulging amniotic sac in adjustment to itsspherical shape, allowing the fetalmembranes to be placed back into theuterus safely and effectively. It has ashape similar to that of a red blood cell ora donut, which provides maximumsurface area to allow the force exerted onthe membranes to be evenly distributed.This causes less trauma and decreases thelikelihood of rupturing the membranes.The firm shaft allows physician to gripthe device with one hand, leaving theother hand entirely free and convenientto suture the cervix. The shaft also hascentimeter gradations marked on it to
ogy JANUARY 2015
indicate the insertion depth during theprocedure. Since we have various sizes ofthe balloon, we can choose the appro-priate size according to degree of cervicaldilation.
The procedure (Figure 2) was per-formed under general anesthesia in theTrendelenburg position. Transabdominalamniocentesis was performed under ul-trasonographic guidance to reduce theamount of amniotic fluid. The fetalmembrane and the cervix were exposedusing 2 Simpson retractors (Figure 2, A,and Figure 3, A), and the cervical edgeswere gently grasped with 2 atraumaticforceps (Figure 2, B).While the cervixwasretracted using the forceps, the uni-concave inflated balloonwas advanced viathe cervical canal to push the bulgingmembranes back into the uterine cavity(Figure 2, C, and Figure 3, B). A McDo-nald cervical cerclage was then performedover the shaft: 1 purse-string suturewith a 5-mm polyester tape was placed(Figure 2, D, and Figure 3, C). Theballoon was then deflated, and the purse-string suture was tied as the instrumentwas withdrawn from the cervix (Figure 2,E, and Figure 3, D). All patients weregiven cephalosporin intravenously in theoperating room. After the surgery, thepatients were treated with bed rest andcontinued tocolysis for 3 days. The pro-cedure was defined as successful when theinternal cervical os was closed with intactmembranes replaced into the uterus.
During the 3-year study period weperformed 103 emergency cervicalcerclages with the uniconcave balloondevice. Of the 103 women, 12 wereexcluded. Eleven patients did not havecomplete medical records, and 1 fetushad a major cardiac anomaly. Table 1shows the patients’ characteristics. Themean gestational age at cerclage place-ment was 21.4 � 2.5 weeks. Cervicaldilation ranged from 1e10 cm. Thepregnancy outcomes are described inTable 2. Of the 91 patients, 23 (25.3%)delivered <24 weeks’ gestation and 34(37.4%) delivered�32 weeks. The meangestational age at delivery was 29.4� 6.7
FIGURE 1Uniconcave balloon
A, Device is composed of balloon, shaft, and valve for air injection. Inflated balloon is not deformed or moved backwards when pushing bulging fetal
membranes because of supportive part on rear side of balloon. Device has centimeter gradations on shaft, so that depth of insertion can be noted. B,Deflated balloon. C, Inflated balloon, shaped like red blood cell or donut.Son. Uniconcave balloon in emergency cerclage. Am J Obstet Gynecol 2015.
FIGURE 2McDonald operation using uniconcave balloon
Illustration of uniconcave balloon used in cerclage procedure. A, Bulging fetal membranes are visualized. B, Cervix is grasped and retracted with 2
atraumatic forceps, and adequately inflated balloon then gently pushes fetal membranes back into uterus. C and D, After fetal membranes are replaced in
uterus, sutures are placed as high as possible in accordance with McDonald technique. E, Balloon is deflated. Purse-string suture is tied as instrument is
withdrawn from cervix.
Son. Uniconcave balloon in emergency cerclage. Am J Obstet Gynecol 2015.
JANUARY 2015 American Journal of Obstetrics & Gynecology 114.e2
ajog.org Surgeon’s Corner
FIGURE 3Photograph demonstrating McDonald operation using uniconcave balloon device
A, Bulging fetal membranes are observed. B, Inflated balloon gently pushes fetal membranes back into uterus. C, Once fetal membranes are back in
uterus, sutures are placed in accordance with McDonald technique. D, Purse-string suture is tied as deflated balloon is withdrawn from cervix.
Son. Uniconcave balloon in emergency cerclage. Am J Obstet Gynecol 2015.
Surgeon’s Corner ajog.org
weeks. The mean prolongation of preg-nancy after cerclage placement was 55.2� 43.0 days (range, 1e140 days). Of the91 pregnancies, 71 (78.0%) ended in livebirth, and themean birthweight was 1.89� 1.0 kg; 66 of the 71 live births survived.
114.e3 American Journal of Obstetrics & Gynecol
Eleven of the 91 patients had completecervical dilation with full bulging ofmembranes into the vagina. In thesepatients, cerclage was performed at 22.5weeks (range, 17.0e24.5 weeks), preg-nancy was prolonged for a median of 19
ogy JANUARY 2015
days (range, 1e114 days), and the me-dian gestational age at delivery was 25.5weeks (range, 18.5e39.0 weeks). Of the11 patients, 8 gave birth to live infants.One newborn who was born at 23.3weeks died of neonatal necrotizing colitis
TABLE 1Characteristics of women undergoing emergency cervical cerclageCharacteristic Total n [ 91 (%)
Maternal age, y 33.2 � 3.5
Obstetric history
Parity
Nullipara 39 (42.9)
Primipara, multipara 52 (57.1)
Previous pregnancies
No. of women delivering at 16-32 wk 18 (19.8)
No. of women delivering at 32-36 6/7 wk 6 (6.6)
No. of women delivering >37 wk 33 (36.2)
Gestational age at cerclage placement, wk 21.4 � 2.5
Maternal serum WBC count on admission, �103/mL 10.6 � 2.3
Cervical dilation at cerclage, cm 3.5 � 2.0
<3 cm 33 (36.3)
�3 cm 58 (63.7)
Location of fetal membranes
Visible at external cervical os 40 (44.0)
Beyond external cervical os 51 (56.0)
Data are mean � SD or n (%), unless otherwise specified.
WBC, white blood cell.
Son. Uniconcave balloon in emergency cerclage. Am J Obstet Gynecol 2015.
ajog.org Surgeon’s Corner
22 days after delivery. The remaining 7neonates are still alive with no remark-able disability.
Cerclage was technically successful inall cases. Rupture of membranes did not
TABLE 2Pregnancy outcomes after emergencPregnancy outcome
Gestational age at delivery, wk
<24
24-27 6/7
28-31 6/7
32-36 6/7
�37
Prolongation of pregnancy, d
Live birth
Birthweight >1500 g
Data are mean � SD or n (%).
Son. Uniconcave balloon in emergency cerclage. Am J Obste
occur at the times of cerclage inany patient, and there were no operativeor anesthetic complications. Our suc-cessful experience in a relatively largenumber of patients leads us to conclude
y cervical cerclageMean ± SD, n (%)
29.4 � 6.7
23 (25.3)
23 (25.3)
11 (12.1)
15 (16.5)
19 (20.9)
55.2 � 43.0
71 (78.0)
40 (44.0)
t Gynecol 2015.
JANUARY 2015 Ameri
that obstetricians could perform emer-gency cerclage with this uniconcaveballoon easily and safely with fewcomplications such as rupture ofmembranes. We expect that our tech-nique will be a great help to the patientswith cervical insufficiency and bulgingfetal membranes. -
ACKNOWLEDGMENT
We would like to thank Su-Jin Jung for theillustration.
REFERENCES
1. Ishikawa K, Watanabe H, Tadokoro N,Oshima K, Nishikawa M, Inaba N. Outcome ofprolapsed chorioamniotic membrane: relation-ship between the degree of herniation, infection,and pregnancy prolongation. Am J Perinatol2003;20:381-9.2. Althuisius SM, Dekker GA, Hummel P,van Geijn HP. Cervical incompetence pre-vention randomized cerclage trial: emer-gency cerclage with bed rest versus bedrest alone. Am J Obstet Gynecol 2003;189:907-10.3. Benifla JL, Goffinet F, Darai E, Proust A, DeCrepy A, Madelenat P. Emergency cervicalcerclage after 20 weeks’ gestation: a retro-spective study of 6 years’ practice in 34 cases.Fetal Diagn Ther 1997;12:274-8.4. Daskalakis G, Papantoniou N, Mesogitis S,Antsaklis A. Management of cervical insuffi-ciency and bulging fetal membranes. ObstetGynecol 2006;107:221-6.5. Harger JH. Cerclage and cervical insuffi-ciency: an evidence-based analysis. ObstetGynecol 2002;100:1313-27.6. Kurup M, Goldkrand JW. Cervicalincompetence: elective, emergent, or urgentcerclage. Am J Obstet Gynecol 1999;181:240-6.7. Pereira L, Cotter A, Gomez R, et al. Expectantmanagement compared with physicalexamination-indicated cerclage (EM-PEC) inselected women with a dilated cervix at 14(0/7)-25(6/7) weeks: results from the EM-PEC inter-national cohort study. Am J Obstet Gynecol2007;197:483.e1-8.8. Stupin JH, David M, Siedentopf JP,Dudenhausen JW. Emergency cerclageversus bed rest for amniotic sac prolapsebefore 27 gestational weeks: a retrospec-tive, comparative study of 161 women. EurJ Obstet Gynecol Reprod Biol 2008;139:32-7.9. Scheerer LJ, Lam F, Bartolucci L,Katz M. A new technique for reduction ofprolapsed fetal membranes for emergencycervical cerclage. Obstet Gynecol 1989;74:408-10.
can Journal of Obstetrics & Gynecology 114.e4
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