Labor Induction After Cesarean Section: Outcome, Hormonal Trends

NCT04244747 | Completed

• 1 other identifier: 0190-15-NHR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives- To compare changes in labour-associated maternal and fetal hormone levels during breast stimulation, balloon induction and spontaneous labour. To compare efficacy and safety of labour induction methods in women with previous caesarean section. Design- Participants were randomized to undergo induction of labour by breast stimulation or intracervical balloon compared to spontaneous labour (controls). Setting- A single tertiary hospital Population- women at term, with previous caesarean section

Conditions

Induction of Labor; Previous Cesarean Section; Hormonal Changes

Keywords

labor induction,; previous caesarean section; hormonal levels; breast stimulation; intracervical balloon

Outcome Measures

Primary Outcomes (7)

• changes in labour-associated maternal and fetal hormone levels

  Maternal serum levels of: oxytocin (pg/mL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined

  at 0, 3 and 6 hours post induction initiation or at controls during the latent phase

• changes in labour-associated maternal and fetal hormone levels

  Maternal serum levels of: prostaglandin F2α (pg/mL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined

  at 0, 3 and 6 hours post induction initiation or at controls during the latent phase

• changes in labour-associated maternal and fetal hormone levels

  Maternal serum levels of: prostaglandin E2 (pg/mL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined

  at 0, 3 and 6 hours post induction initiation or at controls during the latent phase

• changes in labour-associated maternal and fetal hormone levels

  Maternal serum levels of: prolactin (mclU/ml) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined

  at 0, 3 and 6 hours post induction initiation or at controls during the latent phase

• changes in labour-associated maternal and fetal hormone levels

  Maternal serum levels of: estradiol (pmol/L) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined

  at 0, 3 and 6 hours post induction initiation or at controls during the latent phase

• changes in labour-associated maternal and fetal hormone levels

  Maternal serum levels of: cortisol (μGr/dL) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined

  at 0, 3 and 6 hours post induction initiation or at controls during the latent phase

• changes in labour-associated maternal and fetal hormone levels

  Maternal serum levels of: testosterone (nmol/L) were analyzed at 0, 3 and 6 hours post induction initiation (T1, T2, T3) - in two induction groups: catheter balloon and breast stimulation groups the above mentioned parameter was measured also in the third study group: women in their latent phase admitted to the delivery room - the parameter was measured at 0,3,6 hours post admission this parameter was also measured in fetal umbilical cord (F) in women of the three study groups each parameter presented above were reported separately for each group (median at T1, T2, T3 and F) and compared between the three groups inter and intra groups changes were examined

  at 0, 3 and 6 hours post induction initiation or at controls during the latent phase

Secondary Outcomes (4)

• To compare efficacy and safety of labour induction methods in women with previous caesarean section

  at birth

• To compare efficacy and safety of labour induction methods in women with previous caesarean section

  at birth

• To compare efficacy and safety of labour induction methods in women with previous caesarean section

  at birth

• To compare efficacy and safety of labour induction methods in women with previous caesarean section

  at birth

Study Arms (3)

induction of labour by breast stimulation

ACTIVE COMPARATOR

women at term with previous cesarean section and an indication to induce labor. In order to induce labour by breast stimulation, an electrical pump was used. The cup was alternated between the nipples every 15 minutes, with a pause of 15 minutes after each 30 minutes, with a total induction time of 6 hours.

Device: induction of labor by breast stimulation

induction of labour by catheter balloon

ACTIVE COMPARATOR

women at term with previous cesarean section and an indication to induce labor. In the catheter balloon group, a 16-F Foley catheter was inserted into the cervical canal and inflated with 60 cc sterile saline solution and was kept in place for 12 hours.

Device: induction of labor by catheter balloon

spontaneous labour

NO INTERVENTION

women in latent phase of spontaneous labour .

Interventions

induction of labor by breast stimulation DEVICE

Also known as: breast stimulation

induction of labour by breast stimulation

induction of labor by catheter balloon DEVICE

Also known as: catheter balloon

induction of labour by catheter balloon

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women at term pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• uncomplicated pregnancy
• weeks of pregnancy
• singleton pregnancy
• cephalic presentation
• previous one low transverse cesarean section
• indicated induction of labour

You may not qualify if:

• fetal anomaly
• past uterine rupture
• previous preterm cesarean section
• multiple pregnancy
• polyhydramnios
• any contraindication for vaginal delivery or catheter balloon insertion

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galil Medical Center

Nahariya, Israel

Location

Related Publications (12)

• Kota SK, Gayatri K, Jammula S, Kota SK, Krishna SV, Meher LK, Modi KD. Endocrinology of parturition. Indian J Endocrinol Metab. 2013 Jan;17(1):50-9. doi: 10.4103/2230-8210.107841.

  PMID: 23776853 BACKGROUND

• Mears K, McAuliffe F, Grimes H, Morrison JJ. Fetal cortisol in relation to labour, intrapartum events and mode of delivery. J Obstet Gynaecol. 2004 Feb;24(2):129-32. doi: 10.1080/01443610410001645389.

  PMID: 14766445 BACKGROUND

• Takahata K, Horiuchi S, Tadokoro Y, Shuo T, Sawano E, Shinohara K. Effects of breast stimulation for spontaneous onset of labor on salivary oxytocin levels in low-risk pregnant women: A feasibility study. PLoS One. 2018 Feb 15;13(2):e0192757. doi: 10.1371/journal.pone.0192757. eCollection 2018.

  PMID: 29447299 BACKGROUND

• West HM, Jozwiak M, Dodd JM. Methods of term labour induction for women with a previous caesarean section. Cochrane Database Syst Rev. 2017 Jun 9;6(6):CD009792. doi: 10.1002/14651858.CD009792.pub3.

  PMID: 28599068 BACKGROUND

• Harper LM, Cahill AG, Boslaugh S, Odibo AO, Stamilio DM, Roehl KA, Macones GA. Association of induction of labor and uterine rupture in women attempting vaginal birth after cesarean: a survival analysis. Am J Obstet Gynecol. 2012 Jan;206(1):51.e1-5. doi: 10.1016/j.ajog.2011.09.022. Epub 2011 Sep 24.

  PMID: 22000899 BACKGROUND

• Huisman CMA, Ten Eikelder MLG, Mast K, Oude Rengerink K, Jozwiak M, van Dunne F, Duvekot JJ, van Eyck J, Gaugler-Senden I, de Groot CJM, Franssen MTM, van Gemund N, Langenveld J, de Leeuw JW, Oude Lohuis EJ, Oudijk MA, Papatsonis D, van Pampus M, Porath M, Rombout-de Weerd S, van Roosmalen JJ, van der Salm PCM, Scheepers HCJ, Sikkema MJ, Sporken J, Stigter RH, van Wijngaarden WJ, Woiski M, Mol BWJ, Bloemenkamp KWM; PROBAAT-S project group. Balloon catheter for induction of labor in women with one previous cesarean and an unfavorable cervix. Acta Obstet Gynecol Scand. 2019 Jul;98(7):920-928. doi: 10.1111/aogs.13558. Epub 2019 Mar 7.

  PMID: 30723900 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.

  PMID: 25525601 BACKGROUND

• Kehl S, Weiss C, Rath W. Balloon catheters for induction of labor at term after previous cesarean section: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:44-50. doi: 10.1016/j.ejogrb.2016.07.505. Epub 2016 Aug 3.

  PMID: 27521597 BACKGROUND

• Jozwiak M, van de Lest HA, Burger NB, Dijksterhuis MG, De Leeuw JW. Cervical ripening with Foley catheter for induction of labor after cesarean section: a cohort study. Acta Obstet Gynecol Scand. 2014 Mar;93(3):296-301. doi: 10.1111/aogs.12320. Epub 2014 Jan 13.

  PMID: 24354335 BACKGROUND

• Rahm VA, Hallgren A, Hogberg H, Hurtig I, Odlind V. Plasma oxytocin levels in women during labor with or without epidural analgesia: a prospective study. Acta Obstet Gynecol Scand. 2002 Nov;81(11):1033-9. doi: 10.1034/j.1600-0412.2002.811107.x.

  PMID: 12421171 BACKGROUND

• Miller N, Asali AA, Agassi-Zaitler M, Neumark E, Eisenberg MM, Hadi E, Elbaz M, Pasternak Y, Fishman A, Biron-Shental T. Physiological and psychological stress responses to labor and delivery as expressed by salivary cortisol: a prospective study. Am J Obstet Gynecol. 2019 Oct;221(4):351.e1-351.e7. doi: 10.1016/j.ajog.2019.06.045. Epub 2019 Jun 27.

  PMID: 31254523 BACKGROUND

• Wolf MF, Sgayer I, Asslan A, Palzur E, Shnaider O, Bornstein J. The Hormonal Milieu by Different Labor Induction Methods in Women with Previous Cesarean Section: a Prospective Randomized Controlled Trial. Reprod Sci. 2021 Dec;28(12):3562-3570. doi: 10.1007/s43032-021-00667-3. Epub 2021 Jul 6.

  PMID: 34231178 DERIVED

Study Officials

• Maya Wolf, MD

  Galilee Medical Center, Bar-Ilan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of fetal-maternal unit

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 28, 2020
• Study Start: January 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: January 1, 2020
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)