drugset / Trial / NCT05510310
Breast Stimulation vs. Low Dose Oxytocin Augmentation for Labor Induction
RandomizedParallel-groupOpen-labelTreatment
Summary
To find the preferred method of labor induction (birth augmentation) for women with a history of one prior cesarean section scar and in grandmultiparas, the difference in time interval from augmentation to delivery will be measured between breast stimulation vs. low-dose oxytocin administration in this prospective single-center randomized controlled trial.
Timeline
- Start
- 2022-10
- Primary completion
- 2024-10
- Completion
- 2025-04
Publications
- Background Sentilhes L, Vayssiere C, Beucher G, Deneux-Tharaux C, Deruelle P, Diemunsch P, Gallot D, Haumonte JB, Heimann S, Kayem G, Lopez E, Parant O, Schmitz T, Sellier Y, Rozenberg P, d'Ercole C. Delivery for women with a previous cesarean: guidelines for clinical practice from the French College of Gynecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2013 Sep;170(1):25-32. doi: 10.1016/j.ejogrb.2013.05.015. Epub 2013 Jun 28.
- Background Beucher G, Dolley P, Levy-Thissier S, Florian A, Dreyfus M. [Maternal benefits and risks of trial of labor versus elective repeat caesarean delivery in women with a previous caesarean delivery]. J Gynecol Obstet Biol Reprod (Paris). 2012 Dec;41(8):708-26. doi: 10.1016/j.jgyn.2012.09.028. Epub 2012 Nov 14. French.
- Background Penfield CA, Wing DA. Labor Induction Techniques: Which Is the Best? Obstet Gynecol Clin North Am. 2017 Dec;44(4):567-582. doi: 10.1016/j.ogc.2017.08.011.
- Background Deruelle P, Lepage J, Depret S, Clouqueur E. [Induction of labor and intrapartum management for women with uterine scar]. J Gynecol Obstet Biol Reprod (Paris). 2012 Dec;41(8):788-802. doi: 10.1016/j.jgyn.2012.09.030. Epub 2012 Nov 9. French.
- Background Christensson K, Nilsson BA, Stock S, Matthiesen AS, Uvnas-Moberg K. Effect of nipple stimulation on uterine activity and on plasma levels of oxytocin in full term, healthy, pregnant women. Acta Obstet Gynecol Scand. 1989;68(3):205-10. doi: 10.3109/00016348909020990.
- Background Demirel G, Guler H. The Effect of Uterine and Nipple Stimulation on Induction With Oxytocin and the Labor Process. Worldviews Evid Based Nurs. 2015 Oct;12(5):273-80. doi: 10.1111/wvn.12116.
- Background Jhirad A, Vago T. Induction of labor by breast stimulation. Obstet Gynecol. 1973 Mar;41(3):347-50. No abstract available.
- Background Shalev E, Weiner E, Tzabari A, Engelhard J, Zuckerman H, Shalev J, Serr DM. Breast stimulation in late pregnancy. Effect on prostaglandin secretion. Gynecol Obstet Invest. 1990;29(2):125-7. doi: 10.1159/000293317.
- Background Elliott JP, Flaherty JF. The use of breast stimulation to ripen the cervix in term pregnancies. Am J Obstet Gynecol. 1983 Mar 1;145(5):553-6. doi: 10.1016/0002-9378(83)91194-8.
- Background Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003392. doi: 10.1002/14651858.CD003392.pub2.
- Background Singh N, Tripathi R, Mala YM, Yedla N. Breast stimulation in low-risk primigravidas at term: does it aid in spontaneous onset of labour and vaginal delivery? A pilot study. Biomed Res Int. 2014;2014:695037. doi: 10.1155/2014/695037. Epub 2014 Nov 27.
- Background Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2001;(4):CD003392. doi: 10.1002/14651858.CD003392.
- Background Segal S, Gemer O, Zohav E, Siani M, Sassoon E. Evaluation of breast stimulation for induction of labor in women with a prior cesarean section and in grandmultiparas. Acta Obstet Gynecol Scand. 1995 Jan;74(1):40-1. doi: 10.3109/00016349509009941.
- Background Uvnas-Moberg K, Ekstrom-Bergstrom A, Berg M, Buckley S, Pajalic Z, Hadjigeorgiou E, Kotlowska A, Lengler L, Kielbratowska B, Leon-Larios F, Magistretti CM, Downe S, Lindstrom B, Dencker A. Maternal plasma levels of oxytocin during physiological childbirth - a systematic review with implications for uterine contractions and central actions of oxytocin. BMC Pregnancy Childbirth. 2019 Aug 9;19(1):285. doi: 10.1186/s12884-019-2365-9.
- Background Mashini IS, Devoe LD, McKenzie JS, Hadi HA, Sherline DM. Comparison of uterine activity induced by nipple stimulation and oxytocin. Obstet Gynecol. 1987 Jan;69(1):74-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxytocin | Peptide | — | Intravenous |