The aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
309
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.
Unnamed facility
Adelaide, South Australia, Australia
Unnamed facility
Odense, Funen, Denmark
Take-home baby rate
Take-home baby rate was defined as the proportion of living babies discharged from the hospital of all singleton pregnancies.
Time frame: 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.
Gestational age at birth
Evaluated as a continuous variable and as a dichotomous variable (\<34+0 weeks gestation)
Time frame: At birth
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Aalborg, Jutland, Denmark
Unnamed facility
Aarhus, Jutland, Denmark
Unnamed facility
Horsens, Jutland, Denmark
Unnamed facility
Kolding, Jutland, Denmark
Unnamed facility
Viborg, Jutland, Denmark
Unnamed facility
Copenhagen, Region Sjælland, Denmark
Unnamed facility
Gentofte, Copenhagen, Region Sjælland, Denmark
Unnamed facility
Glostrup, Copenhagen, Region Sjælland, Denmark
...and 13 more locations