Status:
RECRUITING
Synbiotics in Patients at RIsk fOr Preterm Birth
Lead Sponsor:
Ziekenhuis Oost-Limburg
Conditions:
Preterm Spontaneous Labor With Preterm Delivery
Preterm Birth
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life...
Eligibility Criteria
Inclusion
- Signed written informed consent must be obtained before any study assessment is performed;
- 18 years of age or older;
- Singleton pregnancy;
- Pregnancy consultation between 8 and 10 weeks gestation.
- At least one of the following risk factors for spontaneous preterm birth:
- Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency
- PPROM ≤36 weeks in previous pregnancy
- Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks.
Exclusion
- Patients who are already using pro-, pre- or synbiotics and not willing to stop
- Multiple pregnancy
- Need for primary (type 1) cerclage
- Inflammatory bowel disease
- Known congenital uterine anomaly
- History of LLETZ conization
Key Trial Info
Start Date :
March 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT05966649
Start Date
March 16 2023
End Date
June 1 2028
Last Update
June 13 2024
Active Locations (7)
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1
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
2
Universitaire Ziekenhuizen Leuven
Leuven, Limburg, Belgium, 3000
3
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
4
AZ Sint-Jan
Bruges, West-Vlaanderen, Belgium, 8300