Status:
UNKNOWN
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children's Long-Term Outcome
Lead Sponsor:
Bürgerhospital Frankfurt
Conditions:
Preterm Birth
Premature Birth
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Preterm birth (PTB) complicates 13% of all pregnancies worldwide and is the most important cause of neonatal morbidity and mortality. Women with a twin pregnancy are at increased risk of preterm deliv...
Detailed Description
Impetus is a prospective, multicentre, multinational, open-label, randomised, controlled clinical trail in parallel groups. For sample size calculation, a the stratified design is accounted for and t...
Eligibility Criteria
Inclusion
- women with a diamniote twin pregnancy at 16-28 weeks of gestation with a shortened cervix ≤ 25 percentile
- women ≥ 18 years and capable of giving consent
Exclusion
- monoamniote pregnancy
- major fetal abnormalities
- suspected twin-to-twin transfusion syndrome
- intrauterine death of one twin
- uterine malformation
- placenta previa totalis
- Cerclage prior to randomization
- active vaginal bleeding and/or spontaneous rupture of membranes and/or painful regular uterine contractions
- silicone allergy
- current participation in other RCT to avoid treatment conflicts
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
672 Patients enrolled
Trial Details
Trial ID
NCT03418311
Start Date
September 1 2020
End Date
December 1 2024
Last Update
May 5 2020
Active Locations (10)
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1
University of Adelaide
Adelaide, Australia
2
Charite-Universitätsmedizin Berlin
Berlin, Germany, 10117
3
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
4
Bürgerhospital Frankfurt/M.
Frankfurt, Germany, 60318