Status:
UNKNOWN
Emergency Cerclage in Twin Pregnancies at Imminent Risk of Preterm Birth: an Open-Label Randomised Controlled Trial
Lead Sponsor:
St George's, University of London
Conditions:
Preterm Birth
Twin Pregnancy With Antenatal Problem
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Twin pregnancies are at an increased risk of early delivery. One of the reasons for this may be due to a weakened neck of the womb (cervix). There are 2 main ways to manage a weakened cervix in pregna...
Detailed Description
The study hypothesis is that the placement of an emergency cervical cerclage prolongs the pregnancy in (1) twin pregnancies with a dilated internal cervical os between 14+0 and 26+0 weeks, and (2) in ...
Eligibility Criteria
Inclusion
- Twin pregnancies presenting with an open cervix between 14 and 26 weeks of gestation, OR
- Twin pregnancies complicated by TTTS treated by Laser surgery between 16+0 and 26+0 weeks' gestation in whom a short cervix (\<15mm) is identified.
- Age \>18 years
- Informed consent
Exclusion
- Cervical dilatation ≥5cm
- Amniotic membranes prolapsed beyond external os into the vagina, unable to visualise cervical tissue
- Preterm premature rupture of the membranes (PPROM) at the time of diagnosis of dilated cervix
- Major fetal malformations unrelated to TTTS
- Intrauterine death of one or both fetuses
- Symptoms or signs of threatened imminent delivery, e.g. painful regular uterine contractions, active vaginal bleeding, history of ruptured membranes
- Suspected chorioamnionitis \[based on maternal uterine tenderness, a temperature of 38°C or greater, significant leucocytosis (\>15,000 x 106/L) or elevated C-reactive protein (\>15 mg/L), or maternal tachycardia\].
- Placenta praevia
- Monochorionic monoamniotic twin pregnancies
- Prophylactic cervical cerclage
- Women who are not able to give valid consent, e.g. unconscious or severely ill
- Mental health disorder which impairs the ability to give fully informed consent
- Women under the age of 18 years
- Higher order multiple pregnancies
Key Trial Info
Start Date :
May 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03818867
Start Date
May 15 2017
End Date
December 1 2019
Last Update
January 28 2019
Active Locations (1)
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1
St George's Hospital
London, United Kingdom, SW17 0QT