Efficacy and safety for women and their unborn babies using misoprostol as a vaginal insert to induce labour for women past 40 weeks of pregnancy

ISRCTN	ISRCTN14702259
DOI	https://doi.org/10.1186/ISRCTN14702259
Secondary identifying numbers	MISO-001

Submission date: 01/06/2020
Registration date: 21/08/2020
Last edited: 04/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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, rudlowski@t-online.de

Contact information

Prof Christian Rudlowski
Scientific

EVK Bergisch Gladbach
Ferrenbergstr 24
Bergisch Gladbach
51465
Germany

Phone	+49 22021222400
Email	rudlowski@t-online.de

Study information

Study design	Observational cohort study non-interventional
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet in German
Scientific title	Efficacy and safety of misoprostol vaginal insert to induce labour in pregnancies beyond 40+0 weeks of gestation
Study objectives	Misoprostol vaginal insert is save and efficient for women with prolonged pregnancies
Ethics approval(s)	Approved 03/01/2014, Local Ethic Commitee, EVK Bergisch Gladbach (Ferrenbergstrasse 24. 51465 Bergisch Gladbach, Germany; +49 22021221088; seelsorge@evk.de), ref: none provided
Health condition(s) or problem(s) studied	Induction of labour in women with prolonged pregnancies
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Misodel (misoprostol)
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 study start date	03/01/2014
Completion date	01/09/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	300
Total final enrolment	304
Key inclusion criteria	1. Aged over 18 years 2. No prior history of Caesarean section 3. Prolonged pregnancy requiring induction of labour
Key exclusion criteria	Contraindications for prostaglandins
Date of first enrolment	01/12/2014
Date of final enrolment	01/09/2019

Locations

Countries of recruitment

Germany

Study participating centre

EVK Hospital Bergisch Gladbach

Department of Obstetrics
Ferrenbergstrasse 24
Bergisch Gladbach
51465
Germany

Sponsor information

Lutheran-Protestant Hospital (EVK)
Hospital/treatment centre

Ferrenbergstr 24
Bergisch Gladbach
51465
Germany

Phone	+49 22021222400
Email	frauenklinik@evk.de
Website	http://www.evk.de

Funders

Funder type

Hospital/treatment centre

EVK Bergisch Gladbach

No information available

Results and Publications

Intention to publish date	01/08/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Preprint results		16/09/2020	04/03/2022	No	No

Editorial Notes

04/03/2022: Link to preprint added.
24/07/2020: Trial’s existence confirmed by Clinical Ethics Committee of the EVK Bergisch Gladbach