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

NCT06788132 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Premature Rupture of Membranes
  • Fetal Complications

Interventions

COMBINATION_PRODUCT

Cranberry products

One capsule of cranberry extract 100mg equivalent 36 mg, hibiscus extract 20 mg, vitamin C 500 mg with lactobacillus 200 MU per day for 10 days

OTHER

Placebo

Starch one capsule per day for 10 days

Sponsors & Collaborators

  • Universidad Nacional Autonoma de Honduras

    collaborator OTHER

  • Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

    lead OTHER

Principal Investigators

  • Ricardo A. Gutierrez Ramirez, MD, MSc. · Universidad Nacional Autonoma de Honduras

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Honduras

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788132 on ClinicalTrials.gov