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โ† Trials
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Synbiotics in Patients at RIsk fOr Preterm Birth

RecruitingNAAges 18 Years - anyFemaleZiekenhuis Oost-Limburg
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In plain words

What the trial is, and whether it could suit you

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. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated. Previous preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth. Infections ascending from the vagina may be an importa

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Signed written informed consent must be obtained before any study assessment is performed; 2. 18 years of age or older; 3. Singleton pregnancy; 4. Pregnancy consultation between 8 and 10 weeks gestation. 5. 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 โ‰ค36 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 Criteria: 1. Patients who are already using pro-, pre- or synbiotics and not willing to stop 2. Multiple pregnancy 3. Need for primary (type 1) cerclage 4. Inflammatory bowel disease 5. Known congenital uterine anomaly 6. History of LLETZ conization
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What it tests

  • Synbiotics
  • Placebo
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Where

9 sites
Universitaire Ziekenhuis Antwerpen
Edegem, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
CHR Citadelle
Liรจge, Belgium
UZ Gent
Ghent, Belgium
AZ Sint-Jan
Bruges, Belgium
AZ Sint-Lucas
Bruges, Belgium
AZ Maria Middelares
Ghent, Belgium

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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