Cervical Occlusion for the Prevention of Preterm Birth

Not Applicable

Terminated

• Conditions: Uterine Cervical Incompetence
• Interventions: Procedure: Cervical occlusion

• Registration Number: NCT01737788
• Lead Sponsor: Niels Jørgen Secher

Brief Summary

The aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages.

Detailed Description

Cervical weakness and ascending infection have long been considered important causes of preterm birth. Cervical occlusion could theoretically be used for the treatment of cervical weakness and to protect the cervix against infection. A cervical cerclage could be placed to increase the cervical resistance, and occlusion of the external os could be performed to retain the cervical mucus plug thereby preventing infection. The aim of this multicentre, stratified, randomised controlled trial was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with prophylactic and therapeutic cervical cerclages.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-11
• Study First Submitted: 2012-11-24
• Study First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Study First Posted: 2012-11-30
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 309

Inclusion Criteria

• The physician in charge considered that a cerclage was indicated.
• Gestational age between 12 and 27 completed weeks.
• Previous late mid-trimester miscarriage, or spontaneous preterm labour and delivery before 28 weeks with or without previous cerclages.
• Previous cerclage because of short cervix.
• Confirmed gestational age defined as gestational age estimated by ultrasound at less than or equal to 22+0 weeks, and/or certain last menstrual period.
• Vaginal infection treated before cerclage.
• Ability to read and understand the relevant national language.
• Consent obtained in accordance with specifications of the local research ethics committee.
• 18 years or more of age and legally competent.

Exclusion Criteria

• Demonstrated cervical infection.
• Obstetrical complications in the current pregnancy.
• Multiple pregnancies.
• History of a significant abruptio placenta in a previous pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Trial	Cervical occlusion	Therapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (\<25mm)
Prophylactic Trial	Cervical occlusion	Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency

Primary Outcome Measures

Name	Time	Method
Take-home baby rate	Neonates will be followed for the duration of stay in the neonatal intensive care unit, an expected average of 28 days with a minimum of 0 days up to a maximum of 98 days.	Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.

Secondary Outcome Measures

Name	Time	Method
Gestational age at birth	At birth	Evaluated as a continuous variable and as a dichotomous variable (\<34+0 weeks gestation)

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark; 🇩🇰 Hvidovre, Zealand, Denmark