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Labor Induction After Cesarean Section: Outcome, Hormonal Trends

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04244747
Enrollment
100
Registered
2020-01-28
Start date
2016-01-31
Completion date
2020-01-01
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormonal Changes, Induction of Labor, Previous Cesarean Section

Keywords

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

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.

Interventions

DEVICEinduction of labor by breast stimulation
DEVICEinduction of labor by catheter balloon

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
changes in labour-associated maternal and fetal hormone levelsat 0, 3 and 6 hours post induction initiation or at controls during the latent phaseMaternal 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

Secondary

MeasureTime frameDescription
To compare efficacy and safety of labour induction methods in women with previous caesarean sectionat birththe 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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026