A multicentre randomised controlled trial of transabdominal versus transvaginal cervical cerclage

• Register: ISRCTN
• Last refreshed on: 1 April 2013
• Main ID: ISRCTN33404560
• Date of registration: 26/09/2008
• Primary sponsor: King's College London (UK)
• Public title: A multicentre randomised controlled trial of transabdominal versus transvaginal cervical cerclage MAVRIC - Multicentre Abdominal vs Vaginal Randomised Investigation of Cerclage
• Date of first enrolment: Jan 1 2008
• Target sample size: 129
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN33404560
• Study type: Interventional
• Study design: Randomised controlled trial

Countries of recruitment

United Kingdom

Contacts

• Name: Andrew Shennan

Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Inability or unwillingness to give informed consent
2. Women under the age of 16

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Preterm birth - prevention

Intervention(s)

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

Primary Outcome(s)

1. Rate of delivery <32 weeks' gestation
2. Rate of neonatal death

Secondary Outcome(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

Secondary ID(s)

Protocol 1

Source(s) of Monetary Support

The Moulton Charitable Foundation (UK)

Secondary Sponsor(s)

N/A