Cervical Occlusion for the Prevention of Preterm Birth

Niels Jørgen Secher

Status: Terminated

Conditions: Uterine Cervical Incompetence

Treatments: Procedure: Cervical occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01737788

CervOcc-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 309 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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309 participants in 2 patient groups

Therapeutic Trial

Experimental group

Description:

Therapeutic cervical cerclage with or without cervical occlusion in women presenting with short cervix (\<25mm)

Treatment:

Procedure: Cervical occlusion

Prophylactic Trial

Experimental group

Description:

Prophylactic cervical cerclage with or without cervical occlusion in women with a history of cervical insufficiency

Treatment:

Procedure: Cervical occlusion