Cranberry, hibiscus, and vitamin C extracts for managing premature rupture of membranes
Cranberry, Hibiscus, and Vitamin C Extracts Versus Placebo in Latency of Premature Rupture of Membranes. Randomized Double-blind Clinical Trial.
This study is testing if cranberry, hibiscus, and vitamin C extracts can help pregnant women with premature rupture of membranes stay pregnant longer before going into labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Universidad Nacional Autonoma de Honduras Academic / other |
| Locations | 1 site (Tegucigalpa, Francisco Morazan) |
| Trial ID | NCT06788132 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of cranberry, hibiscus, and vitamin C extracts on the duration of latency in pregnant women experiencing premature rupture of membranes (PROM) between 24 and 34 weeks of gestation. Conducted as a randomized double-blind trial, 84 participants will be divided into two groups, receiving either the extract combination or a placebo for 10 days. The study aims to determine if these natural supplements can extend the time before labor begins, potentially reducing fetal complications. Data will be analyzed using descriptive statistics to assess the efficacy of the intervention.
Who should consider this trial
Good fit: Ideal candidates are pregnant women between 24 and 34 weeks of gestation with a single non-abnormal fetus experiencing premature rupture of membranes.
Not a fit: Patients with multiple gestations, fetal anomalies, or those who have experienced PROM within 14 days of certain medical procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural intervention to prolong latency in PROM, potentially improving outcomes for both mothers and infants.
How similar studies have performed: While the specific combination of cranberry, hibiscus, and vitamin C has not been extensively tested, other studies on natural supplements for pregnancy complications have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tegucigalpa, Francisco Morazan
- Hospital Escuela — Tegucigalpa, Francisco Morazan, Honduras (Recruiting)
Study contacts
- Study coordinator: Ricardo A. Gutierrez Ramirez, MD, MSc
- Email: ricardo.gutierrez@unah.edu.hn
- Phone: 50497546940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.