Clinical trial NCT04244747: Labor Induction After Cesarean Section: Outcome, Hormonal Trends
Official title: The Hormonal Milieu With Different Methods of Labour Induction: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Previous Cesarean Section
Hormonal Changes
Keywords: labor induction,
previous caesarean section
hormonal levels
breast stimulation
intracervical balloon
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2020-01-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in labour-associated maternal and fetal hormone levels
timeFrame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
measure: changes in labour-associated maternal and fetal hormone levels
timeFrame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
measure: changes in labour-associated maternal and fetal hormone levels
timeFrame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
measure: changes in labour-associated maternal and fetal hormone levels
timeFrame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
measure: changes in labour-associated maternal and fetal hormone levels
timeFrame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
measure: changes in labour-associated maternal and fetal hormone levels
timeFrame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
measure: changes in labour-associated maternal and fetal hormone levels
timeFrame: at 0, 3 and 6 hours post induction initiation or at controls during the latent phase
Secondary outcomes:
measure: To compare efficacy and safety of labour induction methods in women with previous caesarean section
timeFrame: at birth
measure: To compare efficacy and safety of labour induction methods in women with previous caesarean section
timeFrame: at birth
measure: To compare efficacy and safety of labour induction methods in women with previous caesarean section
timeFrame: at birth
measure: To compare efficacy and safety of labour induction methods in women with previous caesarean section
timeFrame: at birth
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Galil Medical Center
Study officials:
affiliation: Galilee Medical Center, Bar-Ilan University
name: Maya Wolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.