Plain English Summary
Background and study aims
One of the most common reasons for inducing labour is a prolonged pregnancy. Prostaglandins (a chemical that is produced in the body) have been proven to induce labour. A drug that can be given to induce labour called misoprostol vaginal insert (MVI) was available in Germany from 2014 to 2019. This study has the aim to clarify whether MVI is safe and efficient for women with prolonged pregnancies (40 to 42 weeks) due to the lack of studies focussing on this particular group of women.
Who can participate?
Pregnant women aged 18 years or above who are 40 or more weeks pregnant.
What does the study involve?
Participants will receive the MVI to induce labour and are closely monitored by the healthcare staff until the baby is delivered.
What are the possible benefits and risks of participating?
None. Treatment is given as usual.
Where is the study run from?
Presbitarian Hospital Bergisch Gladbach (Germany)
When is the study starting and how long is it expected to run for?
January 2014 to September 2019.
Who is funding the study?
Lutheran-Protestant (EVK) Hospital Bergisch Gladbach (Germany)
Who is the main contact?
Prof. Christian Rudlowski, firstname.lastname@example.org
Prof Christian Rudlowski
EVK Bergisch Gladbach
Efficacy and safety of misoprostol vaginal insert to induce labour in pregnancies beyond 40+0 weeks of gestation
Misoprostol vaginal insert is save and efficient for women with prolonged pregnancies
Approved 03/01/2014, Local Ethic Commitee, EVK Bergisch Gladbach (Ferrenbergstrasse 24. 51465 Bergisch Gladbach, Germany; +49 22021221088; email@example.com), ref: none provided
Observational cohort study non-interventional
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet in German
Induction of labour in women with prolonged pregnancies
All women participating in our study gave informed consent. All patients are induced to labour at 40 and more weeks of gestation based on their first-trimester ultrasound examination. Baseline demographic data is collected which includes age, parity, gestational age, gestational diabetes and BISHOP scores, among others. Labour is induced with Misodel® (approved by the European Medicines Agency [EMA]). Prior to the misoprostol vaginal insert application, every woman has a cardiotocography for thirty minutes. A vaginal examination is performed before the vaginal insert placed to determine the cervical ripeness.
Misoprostol is placed in the posterior vaginal fornix and removed within 24 h. Indications for removing misoprostol are either the onset of labour (three or more contractions in 10 min), a cervical dilatation of 4 cm, hyper frequency contractions or after an exposure time of not more than 12 h. All women will have another cardiotocography after MVI removal. The time period from (1) insertion to the onset of labour, (2) onset of labour until delivery and (3) duration from insertion to birth is observed.
Primary outcome measure
Measured using case report forms:
1. Time from insertion to the onset of labour (hours)
2. Time from onset of labour until delivery (hours)
3. Time from insertion to birth was measured (hours)
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Aged over 18 years
2. No prior history of Caesarean section
3. Prolonged pregnancy requiring induction of labour
Target number of participants
Total final enrolment
Participant exclusion criteria
Contraindications for prostaglandins
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
EVK Hospital Bergisch Gladbach
Department of Obstetrics Ferrenbergstrasse 24
EVK Bergisch Gladbach
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)