The Misoprostol Vaginal Insert for Labour Induction

Asklepios Kliniken Hamburg GmbH

Status: Completed

Conditions: Labour Induction

Treatments: Drug: Misoprostol vaginal insert

Study type: Observational

Funder types: Other

Identifiers

NCT03016208

Miso2017

Details and patient eligibility

About

Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) for labour induction using standard (MVI-24) and adjusted (MVI-10) criteria.

Design: Non-interventional observational case control study.

Setting: Tertiary-care academic centre in Germany.

Population: A cohort of 138 pregnant women ≥ 37/0 weeks undergoing labour induction.

Methods: Induction of labour with MVI in a consecutive series of women using standard (MVI-24, n = 69) or adjusted (MVI-10, n = 69) criteria.

Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. The secondary outcomes included the need for additional measures to induce labour, uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.

Enrollment: 138 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gynecologist's indication for induction
• informed consent
• ≥ 37 weeks of gestation
• singleton pregnancies
• cephalic presentation
• cervical Bishop score of < 5 before priming reassuring fetal heart rate

Exclusion criteria

• known hypersensitivity to prostaglandins
• uterine scar
• parity > 5
• any contraindication for vaginal delivery
• cephalopelvic disproportion
• placenta praevia
• chorioamnionitis
• antepartum bleeding of unknown etiology
• cardiopulmonary, renal, hepatic maternal disease
• glaucoma
• fetal congenital abnormalities

Trial design

138 participants in 2 patient groups

Misoprostol vaginal insert for max. 24hrs

Description:

69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 24 hours

Treatment:

Drug: Misoprostol vaginal insert

Misoprostol vaginal insert for max. 10hrs

Description:

69 patients matching the inclusion criteria and received MVI for labour induction for a maximum of 10 hours

Treatment:

Drug: Misoprostol vaginal insert