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New treatment option for Preterm Spontaneous Labor With Preterm Delivery
Official title Synbiotics in Patients at RIsk fOr Preterm Birth
ClinicalTrials.gov ID: NCT05966649
What this study is testing
- What it's testing
- 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, prematurity can cause long-lasting health problems (e.g.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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:
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Edegem, Antwerpen, Belgium
- Genk, Limburg, Belgium
- Leuven, Limburg, Belgium
- Liège, Liège, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Bruges, West-Vlaanderen, Belgium
- Ghent, West-Vlaanderen, Belgium
- Kortrijk, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edegem, Antwerpen, Belgium; Genk, Limburg, Belgium; Leuven, Limburg, Belgium; Liège, Liège, Belgium; Ghent, Oost-Vlaanderen, Belgium; Bruges, West-Vlaanderen, Belgium and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.