Clinical trial NCT01737788: Cervical Occlusion for the Prevention of Preterm Birth
Official title: Randomised Trial of Cervical Cerclage With and Without Occlusion for the Prevention of Preterm Birth in Women Suspected for Cervical Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Cervical Incompetence
Keywords: Cervical cerclage
Uterine Cervical Incompetence
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 309
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Take-home baby rate
timeFrame: 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 outcomes:
measure: Gestational age at birth
timeFrame: At birth
Other outcomes:
measure: Days of admission to the neonatal intensive care unit
timeFrame: 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.
Locations:
city: Adelaide
country: Australia
state: South Australia
city: Odense
country: Denmark
state: Funen
city: Aalborg
country: Denmark
state: Jutland
city: Aarhus
country: Denmark
state: Jutland
city: Horsens
country: Denmark
state: Jutland
city: Kolding
country: Denmark
state: Jutland
city: Viborg
country: Denmark
state: Jutland
city: Copenhagen
country: Denmark
state: Zealand
city: Gentofte, Copenhagen
country: Denmark
state: Zealand
city: Glostrup, Copenhagen
country: Denmark
state: Zealand
city: Herlev, Copenhagen
country: Denmark
state: Zealand
city: Hillerød
country: Denmark
state: Zealand
city: Holbæk
country: Denmark
state: Zealand
city: Hvidovre
country: Denmark
facility: Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
state: Zealand
city: Roskilde
country: Denmark
state: Zealand
city: New Delhi
country: India
city: Makkah
country: Saudi Arabia
state: Makkah Province
city: Pretoria
country: South Africa
state: Gauteng
city: Barcelona
country: Spain
state: Catalonia
city: Malmö
country: Sweden
state: Scania
city: Basel
country: Switzerland
state: Basel-Stadt
city: Liverpool
country: United Kingdom
state: Lancashire
city: London
country: United Kingdom
Study officials:
affiliation: Department of Obstetrics and Gynecology, Hvidovre University Hospital, Denmark
name: Niels J Secher, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brix N, Secher NJ, McCormack CD, Helmig RB, Hein M, Weber T, Mittal S, Kurdi W, Palacio M, Henriksen TB; CERVO group. Randomised trial of cervical cerclage, with and without occlusion, for the prevention of preterm birth in women suspected for cervical insufficiency. BJOG. 2013 Apr;120(5):613-20. doi: 10.1111/1471-0528.12119. Epub 2013 Jan 18.