Labor Induction After Cesarean Section: Outcome, Hormonal Trends

April 11, 2021 updated by: Dr. Maya Wolf, Western Galilee Hospital-Nahariya

The Hormonal Milieu With Different Methods of Labour Induction: a Prospective Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Maternal serum levels of oxytocin, prostaglandin F2α, prostaglandin E2, prolactin, estradiol and cortisol levels were analyzed at 0, 3 and 6 hours post induction initiation, including the two groups catheter balloon and breast stimulation and controls in spontaneous labor. Fetal umbilical cord hormones were measured in the three mentioned above groups. Clinical outcomes were documented in the two induction groups.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Nahariya, Israel
        • Galil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • uncomplicated pregnancy
  • 37-42 weeks of pregnancy
  • singleton pregnancy
  • cephalic presentation
  • previous one low transverse cesarean section
  • indicated induction of labour

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: induction of labour by breast stimulation
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
Other Names:
  • breast stimulation
Active Comparator: induction of labour by catheter balloon
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
Other Names:
  • catheter balloon
No Intervention: spontaneous labour
women in latent phase of spontaneous labour .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in labour-associated maternal and fetal hormone levels
Time Frame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase

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

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

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

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

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

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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare efficacy and safety of labour induction methods in women with previous caesarean section
Time Frame: at birth
the following clinical parameters were measured during the induction process or after delivery in the two induction groups (catheter balloon and breast stimulation): induction to delivery interval time in hours were measured after delivery in the two groups, medians were compared
at birth
To compare efficacy and safety of labour induction methods in women with previous caesarean section
Time Frame: at birth
the following clinical parameters were measured during the induction process or after delivery in the two induction groups (catheter balloon and breast stimulation): fetal apgar score, medians were compared between the two induction groups
at birth
To compare efficacy and safety of labour induction methods in women with previous caesarean section
Time Frame: at birth
the following clinical parameters were measured during the induction process or after delivery in the two induction groups (catheter balloon and breast stimulation):admission to neonatal intensive care unit rate, rates were measured after delivery and compared between the two induction groups
at birth
To compare efficacy and safety of labour induction methods in women with previous caesarean section
Time Frame: at birth
the following clinical parameters were measured during the induction process or after delivery in the two induction groups (catheter balloon and breast stimulation):admission to neonatal intensive uterine rupture rates were compared in the two induction groups after delivery
at birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Investigators

  • Principal Investigator: Maya Wolf, MD, Galilee Medical Center, Bar-Ilan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0190-15-NHR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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