Status:
COMPLETED
Randomized Study of Pessary Versus Standard Management in Women With Increased Chance of Premature Birth
Lead Sponsor:
King's College Hospital NHS Trust
Conditions:
Preterm Birth
Eligibility:
FEMALE
16-45 years
Phase:
PHASE3
Brief Summary
The aim of the study is to determine the effect of cerclage pessary on the incidence of spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic women with singleto...
Detailed Description
Prematurity is responsible for more than half of all neonatal deaths and whilst advances in neonatal care have dramatically improved survival of extremely premature infants, there remains a significan...
Eligibility Criteria
Inclusion
- Women with singleton pregnancies and with a cervical length of 25 mm or less
- Women with twin pregnancies
Exclusion
- Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), fetal death, severe twin to twin transfusion syndrome or severe fetal growth restriction in one of the fetuses (in the case of twin pregnancy) diagnosed before randomization.
- Painful regular uterine contractions, history of ruptured membranes, or prophylactic cerclage before randomization.
- Patients who are unconscious, severely ill, mentally handicapped or under the age of 16 years.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
2109 Patients enrolled
Trial Details
Trial ID
NCT00735137
Start Date
August 1 2008
End Date
February 1 2012
Last Update
February 12 2021
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna-department of Obstetrics and Gynaecology
Vienna, Austria, 1090
2
Universidade Federal Fluminense - Hospital Universitário Antônio Pedro
Niterói, Rio de Janeiro, Brazil, 24033-900
3
University of Campinas
São Paulo, Brazil
4
Hospital Clinico Universidad de Chile
Santiago, Chile