Labor Induction After Cesarean Section: Outcome, Hormonal Trends

Western Galilee Hospital-Nahariya

Status: Completed

Conditions: Previous Cesarean Section; Induction of Labor; Hormonal Changes

Treatments: Device: induction of labor by breast stimulation; Device: induction of labor by catheter balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT04244747

0190-15-NHR

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

induction of labour by breast stimulation

Active Comparator group

Description:

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.

Treatment:

Device: induction of labor by breast stimulation

induction of labour by catheter balloon

Active Comparator group

Description:

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.

Treatment:

Device: induction of labor by catheter balloon

spontaneous labour

No Intervention group

Description:

women in latent phase of spontaneous labour .