Labor Induction After Cesarean Section: Outcome, Hormonal Trends

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Induction of Labor, Previous Cesarean Section, Hormonal Changes

Intervention / Treatment
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* Device: induction of labor by breast stimulation
* Device: induction of labor by catheter balloon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: induction of labour by breast stimulation<br>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<br> <br> * Other names: breast stimulation;|
| Active Comparator: induction of labour by catheter balloon<br>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<br> <br> * Other names: catheter balloon;|
| No Intervention: spontaneous labour<br>women in latent phase of spontaneous labour . | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare efficacy and safety of labour induction methods in women with previous caesarean section | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast stimulation, labor induction,, previous caesarean section, hormonal levels, intracervical balloon