Cervical Occlusion for the Prevention of Preterm Birth

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

Detailed Description
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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.

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

Conditions
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Uterine Cervical Incompetence

Intervention / Treatment
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* Procedure: Cervical occlusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Trial<br>Therapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (<25mm) | Procedure: Cervical occlusion<br>* 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.<br>|
| Experimental: Prophylactic Trial<br>Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency | Procedure: Cervical occlusion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at birth | Evaluated as a continuous variable and as a dichotomous variable (<34+0 weeks gestation) | At birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cerclage, Uterine Cervical Incompetence