Effectiveness and Safety of Amniotomy after Cervical Ripening by Foley’s Catheter Balloon on Induction of Mid-Trimester Fetal Death in Utero: A randomized clinical trial
Article Sidebar
Main Article Content
Abstract
Objectives: To explore the value and safety of amniotomy after cervical ripening by Foley catheter balloon on termination of mid-trimester fetal death in utero.
Materials and Methods: The study was a randomized clinical trial conducted at Assiut Woman’s Health Hospital, Egypt, from November 2021 to June 2023 on non-scared uterus women with mid-trimester fetal death in utero (18-26 weeks). Participants were subjected to Foley catheter balloon insertion and then assigned to group I: Amniotomy group or group II: No amniotomy group according to the randomization. The main outcome was the mean interval (hours) between Foley catheter balloon expulsion to complete abortion. The outcome variables were analyzed using an independent sample t-test, Mann-Whitney U, and Chi-square test.
Results: Sixty women were included in the study. The balloon expulsion to abortion time was shorter in the amniotomy group than the no amniotomy group with a statistically significant difference (6.89 ± 2.02 hours vs 9.22 ± 1.98 hours, p < 0.001). The mean dose of oxytocin was higher in the no amniotomy group than in the amniotomy group with a statistically significant difference (76.61 ±15.78 IU vs 57.55 ±16.88 IU, p < 0.001). No statistically significant differences were found between groups as regards the rate of complications.
Conclusion: Performing amniotomy after using a Foley catheter balloon for cervical ripening during induction of mid-trimester fetal death in utero in a non-scarred uterus reduced the time to abortion as well as the oxytocin dose and the procedure was relatively safe.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
Ushie BA, Izugbara CO, Mutua MM, Kabiru CW. Timing of abortion among adolescent and young women presenting for post-abortion care in Kenya: a cross-sectional analysis of nationally-representative data. BMC Womens Health 2018;18:41.
Sully EA, Atuyambe L, Bukenya J, Whitehead HS, Blades N, Bankole A. Estimating abortion incidence among adolescents and differences in postabortion care by age: a cross-sectional study of postabortion care patients in Uganda. Contraception 2018;98: 510-6.
Chu JJ, Devall AJ, Beeson LE, Hardy P, Cheed V, Sun Y et al. Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial. Lancet 2020;396:770-8.
Dickinson JE, Doherty DA. Mifepristone priming and subsequent misoprostol for second trimester medical abortion in women with previous caesarean delivery. Aust N Z J Obstet Gynaecol 2023;63:301-7.
Mazouni C, Provensal M, Porcu G, Guidicelli B, Heckenroth H, Gamerre M, et al. Termination of pregnancy in patients with previous cesarean section. Contraception 2006;73:244-8.
Ali MK, Botros HA, Mostafa SA. Foley’s catheter balloon for induction of mid-trimester missed abortion with or without traction applied: a randomized controlled trial. J Matern Fetal Neonatal Med 2020;33:198-205.
Demirezen G, Aslan Çetin B, Aydoğan Mathyk B, Köroğlu N, Yildirim G. Efficiency of the Foley catheter versus the double balloon catheter during the induction of second trimester pregnancy terminations: a randomized controlled trial. Arch Gynecol Obstet 2018;298:881-7.
Velipasaoglu M, Ozdemir CY, Ozek B, Ayaz R, Tanir HM. Sequential use of Foley catheter with misoprostol for second trimester pregnancy termination in women with and without caesarean scars: a prospective cohort study. J Matern Fetal Neonatal Med 2018;31:677-81.
Rezk MA, Sanad Z, Dawood R, Emarh M, Masood A. Comparison of intravaginal misoprostol and intracervical Foley catheter alone or in combination for termination of second trimester pregnancy. J Matern Fetal Neonatal Med 2015;28:93-6.
Aduloju OP, Akintayo AA, Adanikin AI, Ade-Ojo IP. Combined Foley’s catheter with vaginal misoprostol for pre-induction cervical ripening: A randomised controlled trial. Aust N Z J Obstet Gynaecol 2016;56:578-84.
Bostancı E, Eser A, Yayla Abide C, Kılıccı C, Kucukbas M. Early amniotomy after dinoprostone insert used for the induction of labor: a randomized clinical trial. J Matern Fetal Neonatal Med 2018;31:352-6.
Titulaer LML, de Wolf GS, Bakkum EA, Moll E. Delayed versus immediate oxytocin infusion after amniotomy for induction of labour: A randomised controlled pilot trial. Eur J Obstet Gynecol Reprod Biol 2019;240:357-63.
De Vivo V, Carbone L, Saccone G, Magoga G, De Vivo G, Locci M et al. Early amniotomy after cervical ripening for induction of labor: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol 2020;222:320-9.
Laughon SK, Zhang J, Troendle J, Sun L, Reddy UM. Using a simplified Bishop score to predict vaginal delivery. Obstet Gynecol 2011;117:805-11.
Asadi N, Vafaei H, Hessami K, Darabi MH, Kasraeian M, Faraji A et al. Vaginal misoprostol and intravenous oxytocin for success of termination in the second-trimester intrauterine fetal demise: A randomized controlled clinical trial. J Obstet Gynaecol Res 2022;48:966-72.
Hu Q, Li C, Luo L, Li J, Zhang X, Chen S et al. Clinical analysis of second-trimester pregnancy termination after previous caesarean delivery in 51 patients with placenta previa and placenta accreta spectrum: a retrospective study. BMC Pregnancy Childbirth 2021;21:568.
Latta K, Barker E, Kendall P, Testani E, Laursen L, McClosky L et al. Complications of second trimester induction for abortion or fetal demise for patients with and without prior cesarean delivery. Contraception 2023;117:55-60.
Diedrich JT, Drey EA, Newmann SJ. Society of Family Planning clinical recommendations: Cervical preparation for dilation and evacuation at 20-24 weeks’ gestation. Contraception 2020;101:286-92.
Sium AF, Prager S, Wolderufael M, Abubeker FA, Tufa TH, Grentzer JM. Foley catheter for cervical preparation prior to second trimester dilation and evacuation: A supply-based alternative for surgical abortion: A case series. Contracept X 2022;4:100085.
Radzinsky VE, Startseva NM, Doronina OK, Teplov KV, Borisova AV. Mifepristone versus balloon catheter for labor induction: a cohort study. J Matern Fetal Neonatal Med 2022;35:9331-5.
M K, Jain V, Arora A, Kumar J. Comparison of Vaginal dinoprostone pessary with transcervical balloon catheter plus vaginal misoprostol for pre-induction cervical ripening: A randomized trial. Cureus 2023;15: e42261.
Mahdy H, Glowacki C, Eruo FU. Amniotomy. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023
Afrose R, Mirza TT, Sarker K, Shamsi S, Chowdhury UW, Shikha SS, et al. Effect of amniotomy on outcome of spontaneous labour. Mymensingh Med J 2021;30: 6-12.
AboBakr AM, Ahmed MA, Mohamed SA, M.D. Intra uterine extra-amniotic versus vaginal misoprostol for termination of second trimester miscarriage: A randomized controlled trial. Int J Reprod Biomed (Yazd) 2016;14: 643–8.
Chandrasekaran S, Paul M, Ruggiero S, Monschauer E, Blanchard K, Robinson Y. Foley catheter and misoprostol for cervical preparation for second-trimester surgical abortion. Contraception 2021;104:437-41.
Ercan Ö, Köstü B, Özer A, Serin S, Bakacak M. Misoprostol versus misoprostol and foley catheter combination in 2nd trimester pregnancy terminations. J Matern Fetal Neonatal Med 2016;29:2810-2.
Bani-Irshaid I, Athamneh TZ, Bani-Khaled D, Al-Momani M, Dahamsheh H. Termination of second and early third trimester pregnancy: comparison of 3 methods. East Mediterr Health J 2006;12:605-9.
Fathalla MM, Maghraby AM, AL-Hussaini TK, IsmailAM. Different methods of termination of second trimester pregnancy at Women′s Health Hospital, Assiut University: efficacy and complications. Int J Reprod Contracept Obstet Gynecol 2017;6:3241-6.
Tu YA, Chen CL, Lai YL, Lin SY, Lee CN. Transcervical double-balloon catheter as an alternative and salvage method for medical termination of pregnancy in midtrimester. Taiwan J Obstet Gynecol 2017;56:77-80.
Toptas T, Mendilcioglu I, Simsek M, Taskin O. Intravaginal misoprostol alone versus intravaginal misoprostol and extra amniotic Foley catheter for second trimester pregnancy termination: an observational study. Ginekol Pol 2014;85:577-81.
Abbas DF, Blum J, Ngoc NT, Nga NT, Chi HT, Martin R, et al. Simultaneous administration compared with a 24-hour mifepristone-misoprostol interval in second-trimester abortion: A randomized controlled trial. Obstet Gynecol 2016;128:1077-83.
Kashanian M, Akbarian A, Baradaran H. Extra-amniotic saline infusion vs. cervical traction with Foley catheter for second-trimester pregnancy termination. Int J Gynaecol Obstet 2006;92:159-60.
Fonseca MN, SahV. Comparative study between sequential use of Foley catheter with vaginal misoprostol versus sequential use of oral mifepristone with vaginal misoprostol for second trimester medical abortion. Int J Reprod Contracept Obstet Gynecol 2018;7:4545-50
El Sharkwy IAE, Elsayed ML, Ahmed MA, Alnemer AAA. Low-dose vaginal misoprostol with or without Foley catheter for late second-trimester pregnancy termination in women with previous multiple cesarean sections. J Matern Fetal Neonatal Med 2019;32: 3703-7.
Dick A, Gutman-Ido E, Chill HH, Karavani G, Ryvkin I, Porat S, et al. Artificial rupture of membranes as a mode for induction of labor in women with a previous cesarean section- a retrospective cohort study. BMC Pregnancy Childbirth 2022;22:886.
Fieldwick D, Power O, Sood M. Massive antepartum haemorrhage at insertion of Foley balloon catheter for induction of labour. BMJ Case Rep 2021;14:e239591.