A multicentre randomised controlled trial of transabdominal versus transvaginal cervical cerclage

ISRCTN	ISRCTN33404560
DOI	https://doi.org/10.1186/ISRCTN33404560
Protocol serial number	Protocol 1
Sponsor	King's College London (UK)
Funder	The Moulton Charitable Foundation (UK)

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 of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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 objectives	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
Health condition(s) or problem(s) studied	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(s)	1. Rate of delivery <32 weeks' gestation 2. Rate of neonatal death
Key secondary outcome measure(s)	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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	129
Total final enrolment	111
Key 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
Key exclusion criteria	1. Inability or unwillingness to give informed consent 2. Women under the age of 16
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College London

London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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.