Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.stuitonderzoek.nl

Contact information

Type

Scientific

Primary contact

Dr M. Kok

ORCID ID

Contact details

Academic Medical Centre
Department of Obstetrics and Gynaecology
H4-205
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5664167
mkok@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR140

Study information

Scientific title

Management of breech presentation - external cephalic version with tocolysis: a multicentre randomised controlled trial

Acronym

Study hypothesis

For women with a singleton at term foetus in breech presentation, what is the success rate of external cephalic version (ECV) with a calcium antagonist nifedipine compared to version without medication?

Ethics approval

Ethics approval received from local ethics committee

Study design

Multicentre, randomised, double blind, placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Breech presentation

Intervention

Group 1: external cephalic version with tocolysis (adalat 10 mg orally 30 and 15 minutes before procedure)
Group 2: external cephalic version without tocolysis.

Intervention type

Drug

Phase

Not Specified

Drug names

Tocolysis

Primary outcome measures

Successful version.

Secondary outcome measures

1. Cephalic presentation at birth
2. Caesarean section rate
3. Foetal complications
4. Maternal complications

Overall trial start date

01/08/2004

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant women (from 18 years of age) with a live singleton at term foetus in breech presentation.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300

Participant exclusion criteria

1. Contraindications to labour or vaginal birth
2. Any contraindication to ECV
3. Contraindications for nifedipine

Recruitment start date

01/08/2004

Recruitment end date

01/05/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18669722

Publication citations

  1. Results

    Kok M, Bais JM, van Lith JM, Papatsonis DM, Kleiverda G, Hanny D, Doornbos JP, Mol BW, van der Post JA, Nifedipine as a uterine relaxant for external cephalic version: a randomized controlled trial., Obstet Gynecol, 2008, 112, 2 Pt 1, 271-276, doi: 10.1097/AOG.0b013e31817f1f2e.

Additional files

Editorial Notes