Condition category
Pregnancy and Childbirth
Date applied
01/06/2020
Date assigned
21/08/2020
Last edited
21/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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, rudlowski@t-online.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christian Rudlowski

ORCID ID

Contact details

EVK Bergisch Gladbach
Ferrenbergstr 24
Bergisch Gladbach
51465
Germany
+49 22021222400
rudlowski@t-online.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

MISO-001

Study information

Scientific title

Efficacy and safety of misoprostol vaginal insert to induce labour in pregnancies beyond 40+0 weeks of gestation

Acronym

Study hypothesis

Misoprostol vaginal insert is save and efficient for women with prolonged pregnancies

Ethics approval

Approved 03/01/2014, Local Ethic Commitee, EVK Bergisch Gladbach (Ferrenbergstrasse 24. 51465 Bergisch Gladbach, Germany; +49 22021221088; seelsorge@evk.de), ref: none provided

Study design

Observational cohort study non-interventional

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet in German

Condition

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

Phase

Phase IV

Drug names

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 trial start date

03/01/2014

Overall trial end date

01/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. No prior history of Caesarean section
3. Prolonged pregnancy requiring induction of labour

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300

Total final enrolment

304

Participant exclusion criteria

Contraindications for prostaglandins

Recruitment start date

01/12/2014

Recruitment end date

01/09/2019

Locations

Countries of recruitment

Germany

Trial participating centre

EVK Hospital Bergisch Gladbach
Department of Obstetrics Ferrenbergstrasse 24
Bergisch Gladbach
51465
Germany

Sponsor information

Organisation

Lutheran-Protestant Hospital (EVK)

Sponsor details

Ferrenbergstr 24
Bergisch Gladbach
51465
Germany
+49 22021222400
frauenklinik@evk.de

Sponsor type

Hospital/treatment centre

Website

http://www.evk.de

Funders

Funder type

Hospital/treatment centre

Funder name

EVK Bergisch Gladbach

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/07/2020: Trial’s existence confirmed by Clinical Ethics Committee of the EVK Bergisch Gladbach