Misoprostol for Labour Induction

Asklepios Kliniken Hamburg GmbH

Status

Completed

Conditions

Labour Induction

Study type

Observational

Funder types

Other

Identifiers

NCT02904317

PV4803-2

Details and patient eligibility

About

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.

Full description

Open, non-interventional study in a tertiary referral center in Germany N/A The rationale of our observational study is to describe the efficacy and safety profile of the drug with definition of active labor according to local clinical practice in a descriptive observational study in a tertiary referral center.

A time interval from induction of labor to delivery is depending on the duration of the MISODEL® application. By an observational study the investigators want to describe the efficacy and safety with regard to time to delivery and complication rate.

Primary Objective:

The aim of this study is to describe time to vaginal delivery with definition of active labor according to local clinical practice.

The time period needed to induce any delivery and to describe the drug safety profile.

Primary endpoints:

Time to vaginal delivery in hours in patients with vaginal delivery.
Length of time until any delivery
Caesarean section rate
Time until onset of labor
Frequency of vaginal operative delivery
Frequency of abnormal CTG (Figo)
Frequency of uterine Tachysystole leading to abnormal fetal heartrate i.e. Figo P. Tachysystole is defined as five or more contractions in 10 minutes averaged over three consecutive 10-minute periods.
Written informed consent of the patients
≥18 years of age
Parity five or less with singleton pregnancies
≥36 weeks of gestation
Unfavourable cervix (baseline modified Bishop score ≤6)

Misoprostol 200mcg VDS is contraindicated according to the SmPC in the following cases:

When there is hypersensitivity to the active substance or to any of the excipients
When labour has started
When oxytocic drugs and/or other labour induction agents are being given
When there is suspicion or evidence of uterine scar resulting from previous uterine surgery, e.g. C-section
When there is uterine abnormality (e.g. bicornate uterus)
When there is placenta praevia or unexplained vaginal bleeding after 24 weeks gestation with this pregnancy
When there is foetal malpresentation
When there are signs or symptoms of chorioamnionitis, unless adequate prior treatment has been instituted
Before week 36 of gestation

For evaluation of the primary and secondary endpoints of the study, descriptive statistical methods will be used.

Enrollment

138 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria