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

NCT06788132 | Completed DMC

• 1 other identifier: PGO-UNAH-48-5-2025
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cranberry; Hibiscus; Vitamin C; Premature Rupture of membranes

Outcome Measures

Primary Outcomes (1)

• Duration of latency

  change in the duration of the latency of premature rupture of membranes in number of days

  Since intervention until delivery, assessed up to 48 hours

Secondary Outcomes (2)

• neonatal complications

  Since intervention until neonatal discharge, assessed up to 28 days.

• maternal complications

  Since intervention until maternal discharge, assessed up to 30 days.

Study Arms (2)

Cranberry, hibiscus and vitamin c extracts

EXPERIMENTAL

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 for 10 days

Combination Product: Cranberry products

Starch

PLACEBO COMPARATOR

One capsule of Starch per day for 10 days

Other: Placebo

Interventions

Cranberry products COMBINATION_PRODUCT

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

Cranberry, hibiscus and vitamin c extracts

Placebo OTHER

Starch one capsule per day for 10 days

Starch

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ricardo A Gutierrez Ramirez, MD, MSc, FACOG: lead
• Universidad Nacional Autonoma de Honduras: collaborator

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Related Publications (1)

• Gungorduk K, Asicioglu O, Gungorduk OC, Yildirim G, Besimoglu B, Ark C. Does vitamin C and vitamin E supplementation prolong the latency period before delivery following the preterm premature rupture of membranes? A randomized controlled study. Am J Perinatol. 2014 Mar;31(3):195-202. doi: 10.1055/s-0033-1343774. Epub 2013 Apr 16.

  PMID: 23592317 BACKGROUND

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ricardo A. Gutierrez Ramirez, MD, MSc.

  Universidad Nacional Autonoma de Honduras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: randomized, controlled, prospective, prospective, single-center, double-blind, parallel group, efficacy and superiority clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: randomized, controlled, prospective, prospective, single-center, double-blind, parallel group, efficacy and superiority clinical trial

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 22, 2025
• Study Start: January 30, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)