Cranberry, Hibiscus, and Vitamin C Extracts Versus Placebo in Latency of Premature Rupture of Mem… (NCT06788132) | Clinical Trial Compass
CompletedNot Applicable
Cranberry, Hibiscus, and Vitamin C Extracts Versus Placebo in Latency of Premature Rupture of Membranes.
Honduras84 participantsStarted 2025-01-30
Plain-language summary
The main objective of this clinical trial is to evaluate the effect of cranberry, hibiscus and vitamin C extracts supplementation on the duration of the latency of premature rupture of membranes in pregnant women between 24 and 34 weeks with PROM compared to placebo administration through a randomized double-blind clinical trial, which will be carried out from July to December 2024 in the pathological hospitalization ward of the Hospital Materno Infantil, with a sample of 84 pregnant women, divided into 2 equal groups (A and B), a control group and a placebo group, where 1 capsule per day will be administered, containing a combination of blueberry extract 100mg equivalent 36 mg, hibiscus extract 20 mg, vitamin C 500 mg with lactobacillus 200 MU or a starch capsule for 10 days. In addition, routine complementary studies will be carried out and through descriptive statistics using Redcap for data tabulation and analysis, it will be possible to prove or reject the hypothesis that proposes that the use of cranberry, vitamin C and Hibiscus supplementation does not prolong the latency of premature rupture of membranes.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who agree to participate in the study.
* Patients who sign the informed consent form.
* Patients who can read and write.
* Patients without alterations in the cognitive system.
* Patients who had their delivery at the Maternal and Child Hospital.
* Patients with admission criteria for conservative management in the pathology ward of the Hospital Escuela.
* Patients with a single non-abnormal fetus.
* Premature rupture of membranes with pregnancy of \>24.0 and \<34.0 weeks of gestation.
Exclusion Criteria:
* Patients who do not wish to participate in the study
* Fetus with pulmonary anomalies, central nervous system and cardiopathies.
* Patient with chorioamnionitis.
* Premature rupture of membranes experienced within 14 days after amniocentesis or cervical cerclage placement.
* Multiple gestation.
* Delivery within 24 hours after admission.
* Intrauterine fetal death at presentation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of latency
Timeframe: Since intervention until delivery, assessed up to 48 hours
Trial details
NCT IDNCT06788132
SponsorRicardo A Gutierrez Ramirez, MD, MSc, FACOG