Uterine Cervical Incompetence
Conditions
Keywords
Cervical cerclage, Uterine Cervical Incompetence
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.
Interventions
PROCEDURECervical 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.
Sponsors
Niels Jørgen Secher
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Gestational age at birth | At birth | Evaluated as a continuous variable and as a dichotomous variable (\<34+0 weeks gestation) |
Other
| Measure | Time frame |
|---|---|
| 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. |
Countries
Australia, Denmark, India, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed