Condition category
Pregnancy and Childbirth
Date applied
29/08/2008
Date assigned
26/09/2008
Last edited
06/06/2016
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.medscinet.net/mavric/

Contact information

Type

Scientific

Primary contact

Prof Andrew Shennan

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol 1

Study information

Scientific title

A multicentre randomised controlled trial of transabdominal versus transvaginal cervical cerclage

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

South East Research Ethics Committee, 20/11/2007, ref: 07/H1102/113

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Patient information can be found at: http://www.medscinet.net/mavric/patientinfodocs/PIS_221107[1].doc

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

129

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

United Kingdom

Trial participating centre

King's College London
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

c/o Keith Brennan
Assistant Head of Administration (Health)
Room 1.8
Hodgkin Building
Guy's Campus
London
SE1 4UL
United Kingdom
+44 (0)207 848 6960
keith.brennan@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk

Funders

Funder type

Charity

Funder name

The Moulton Charitable Foundation (UK)

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

Publication citations

Additional files

Editorial Notes

06/06/2016: No publications found, verifying study status with principal investigator.