A multicentre randomised controlled trial of transabdominal versus transvaginal cervical cerclage

ISRCTN	ISRCTN33404560
DOI	https://doi.org/10.1186/ISRCTN33404560
Secondary identifying numbers	Protocol 1

Submission date: 29/08/2008
Registration date: 26/09/2008
Last edited: 06/05/2020

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

Not provided at time of registration

Study website

Contact information

Prof Andrew Shennan
Scientific

King's College London
Division of Reproduction & Endocrinology
Maternal and Foetal Research Unit
10th Floor North Wing
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Phone	+44 (0)207 188 3639
Email	andrew.shennan@kcl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Patient information can be found at: http://www.medscinet.net/mavric/patientinfodocs/PIS_221107[1].doc
Scientific title	A multicentre randomised controlled trial of transabdominal versus transvaginal cervical cerclage
Study acronym	MAVRIC - Multicentre Abdominal vs Vaginal Randomised Investigation of Cerclage
Study hypothesis	A transbadominal or a high vaginal cerclage will be associated with a lower rate of preterm birth (<32 weeks) and neonatal death than a low vaginal cerclage in women who have had a second trimester loss or early preterm birth (<28 weeks) despite having a low vaginal cerclage in situ.
Ethics approval(s)	South East Research Ethics Committee, 20/11/2007, ref: 07/H1102/113
Condition	Preterm birth - prevention
Intervention	The participants will be randomly allocated to the following three arms: 1. Low vaginal cervical cerclage 2. High vaginal cervical cerclage 3. Transabdominal cervical cerclage
Intervention type	Procedure/Surgery
Primary outcome measure	1. Rate of delivery <32 weeks' gestation 2. Rate of neonatal death
Secondary outcome measures	1. Serious operative complication rates 2. Complications of pre- and post-conception cerclages for high vaginal cerclages and transabdominal cerclages Duration of follow up: a maximum of 2 years
Overall study start date	01/01/2008
Overall study end date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	129
Total final enrolment	111
Participant inclusion criteria	1. Previous second trimester miscarriage or preterm birth before 28 weeks' gestation despite having a low vaginal cerclage in place 2. Not yet pregnant or <14 weeks' pregnant
Participant exclusion criteria	1. Inability or unwillingness to give informed consent 2. Women under the age of 16
Recruitment start date	01/01/2008
Recruitment end date	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

King's College London

London
SE1 7EH
United Kingdom

Sponsor information

King's College London (UK)
University/education

c/o Keith Brennan
Assistant Head of Administration (Health)
Room 1.8
Hodgkin Building
Guy's Campus
London
SE1 4UL
England
United Kingdom

Phone	+44 (0)207 848 6960
Email	keith.brennan@kcl.ac.uk
Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Charity

The Moulton Charitable Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2020	06/05/2020	Yes	No

Editorial Notes

06/05/2020: Publication reference and total final enrolment number added.
06/06/2016: No publications found, verifying study status with principal investigator.