Cervical incompetence Pregnancy and Childbirth Maternal care for cervical incompetence
Conditions
Interventions
Women will be randomised to either:
1. Cerclage group
2. Amniocentesis and cerclage group
Randomisation will be organised by a random numbers table and assigned by telephone. Women randomised to the
Sponsors
Mount Sinai Hospital (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Singleton gestation 2. Presence of cervical dilatation 3. Membranes visible at or protruding through the cervical opening 4. Absence of any uterine activity 5. Absence of any overt signs of maternal infection: 5.1. Maternal temperature greater than 37.8°C 5.2. Diffuse abdominal pain 5.3. Foul/pus like discharge 5.4. Maternal or foetal tachycardia
Exclusion criteria
Exclusion criteria: 1. Intrauterine foetal demise or distress 2. Intrauterine growth restriction 3. Foetal anomaly 4. Poly- or oligo-hydramnious 5. Ruptured foetal membranes 6. Current history of significant antepartum haemorrhage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary comparison will be the prolongation of gestation to greater than 34 weeks of gestation, defined as rescue cerclage success. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maternal morbidity: will include complications of cerclage insertion, through gestation and at the time of the delivery 2. Neonatal morbidity: will include complications during the initial admission to the nursery following the delivery | — |
Countries
Canada
Outcome results
None listed