drugset / Trial / NCT06788132

Cranberry, Hibiscus, and Vitamin C Extracts Versus Placebo in Latency of Premature Rupture of Membranes.

NCT06788132

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2025-01-30
Primary completion
2025-07-31
Completion
2025-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cranberry juice Unknown 100 mg
Subject Lactobacillus Unknown 200 unknown
Subject Vitamin C Other / unclassified 500 mg
Subject hibiscus extract Unknown 20 mg