Cervical Occlusion for the Prevention of Preterm Birth

Uterine Cervical Incompetence Clinical Trial

Official title:

Randomised Trial of Cervical Cerclage With and Without Occlusion for the Prevention of Preterm Birth in Women Suspected for Cervical Insufficiency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01737788
• Other study ID #: CervOcc-001
• Status: Terminated
• Phase: N/A
• First received: November 24, 2012
• Last updated: November 29, 2012
• Start date: August 2006
• Est. completion date: August 2011

Study information

• Verified date: November 2012
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 309
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Uterine Cervical Incompetence

Intervention

Procedure:
• Cervical occlusion
Women were randomized to receive cervical occlusion or no cervical occlusion in addition to a cervical cerclage (McDonald or Shirodkar cerclage). Cervical occlusion was performed with interrupted or continuous sutures, placed approximately 1 cm deep on each lip, and 0.5 cm apart with a nylon 2-0/3-0 suture.

Locations

Country	Name	City	State
Denmark	Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark	Hvidovre	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Niels Jørgen Secher

Countries where clinical trial is conducted

Australia,  Denmark,  India,  Saudi Arabia,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Days of admission to the neonatal intensive care unit		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.	No
Primary	Take-home baby rate	Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.	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.	No
Secondary	Gestational age at birth	Evaluated as a continuous variable and as a dichotomous variable (<34+0 weeks gestation)	At birth	No