Skip to main content
OpenTrials
Completed

NCT Number: NCT04244747

Labor Induction After Cesarean Section: Outcome, Hormonal Trends

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Induction of Labor Hormonal Changes Previous Cesarean Section

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Galil Medical Center

Nahariya, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

induction of labor by breast stimulation

Device

Other names: breast stimulation

induction of labor by catheter balloon

Device

Other names: catheter balloon

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jan 28, 2020
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.