Misoprostol for Labour Induction

NCT02904317 | Completed

• 1 other identifier: PV4803-2
• Study Type: observational
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To compare the efficacy and safety of the misoprostol vaginal insert (MVI) with an off-label use of oral misoprostol (OM). Design: Pair-matched case-control study. Setting: Tertiary-care academic centre in Germany. Population: A cohort of 138 women ≥ 37/0 weeks pregnant undergoing labour induction. Methods: The induction of labour with a retrievable prostaglandin vaginal insert in a consecutive series of 69 women was compared with induction using oral misoprostol in a pair-matched cohort. Main outcome measures: The primary outcomes were the time from induction to delivery and the caesarean section rate. Secondary outcomes included uterine tachysystole, tocolysis, fetal scalp blood testing, meconium-stained amniotic fluid, umbilical arterial pH, and Apgar score.

Conditions

Labour Induction

Outcome Measures

Primary Outcomes (1)

• time from application of the medication until delivery in minutes

  September 2015

Secondary Outcomes (4)

• Rate of participants receiving a caesarean section compared to all participants being induced

  September 2015

• Number of participants with treatment-related tachysystole as assessed by cardiotocography

  September 2015

• Number of participants with treatment-related adverse events following tocolysis with Partusisten

  September 2015

• Number of participants with fetal compromise assessed by the APGAR-Score and the postpartum fetal pH-value

  September 2015

Study Arms (2)

Misprostol vaginal insert for labour induction

69 patients matching the inclusion criteria and received MVI for labour induction

Oral misoprostol for labour induction

69 patients matching the inclusion criteria and received OM for labour induction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• gynaecologist'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

You may not qualify if:

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

Sponsors & Collaborators

• Asklepios Kliniken Hamburg GmbH: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: September 16, 2016
• Study Start: August 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: January 1, 2016
• Last Updated: September 16, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share