Status:
UNKNOWN
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
Lead Sponsor:
Bürgerhospital Frankfurt
Conditions:
Preterm Birth
Premature Birth
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at deliver...
Detailed Description
The "Prometheus Trial" is a prospective, multicentre, multinational, open-label, randomised, controlled clinical trial in parallel groups. Up to now the risk factor previous PTB has only been investi...
Eligibility Criteria
Inclusion
- Women with a singleton pregnancy and a history of at least one previous preterm delivery before 34+0 weeks and/or a history of at least one previous cervical surgery
- 12+0 - 16+0 weeks of gestation at time of randomization
- only women with minimum age of 18 and capable of giving consent
Exclusion
- major fetal abnormalities
- uterine malformation, placenta previa totalis
- Cerclage prior to randomization
- At randomisation: active vaginal bleeding and/or spontaneous rupture of membranes and/or painful regular uterine contractions
- silicone allergy
- current participation in other RCT
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT03418012
Start Date
September 1 2020
End Date
October 1 2024
Last Update
May 5 2020
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Adelaide
Adelaide, Australia
2
Charité - Universitätsmedizin
Berlin, Germany, 10117
3
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
4
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590