Cranberry, Hibiscus, and Vitamin C Extracts Versus Placebo in Latency of Premature Rupture of Membranes. (SBERRY)
August 30, 2025 updated by: Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Cranberry, Hibiscus, and Vitamin C Extracts Versus Placebo in Latency of Premature Rupture of Membranes. Randomized Double-blind Clinical Trial.
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Premature Rupture of Membranes (PROM) is the loss of the integrity of the amniotic membranes, which includes amniotic fluid leakage via the transvaginal route and manifests itself prior to the onset of labor.
It has a worldwide prevalence between 2 and 4% as a complication of pregnancies, which means that it plays an important role in preterm births and maternal-fetal complications as it is a very frequent identifiable factor.
Latin America is no exception, Peru has reported up to 0.31% of the total morbidities attended in the Emergency Obstetric Service.
Its management can vary from expectant, pharmacological to surgical depending on factors associated with the mother and the product, for example, gestational age, clinical condition of the mother, toxic habits, among others.
Epidemiological studies carried out in Mexico explain a series of factors that increase the risk of PROM.
These include: maternal reproductive tract infections (bacterial vaginitis, trichomonas, gonorrhea, chlamydia and occult chorioamnioitis); behavioral factors (smoking, substance abuse, nutritional status and sexual relations); obstetric complications (multiple pregnancy, polyhydramnios, cervical incompetence, hemorrhage during pregnancy and trauma during pregnancy), as well as environmental changes (barometric pressure).
On the other hand, the results of epidemiological, clinical, histological, microbiological and molecular biology studies support that focal infection and inflammation play a primary and secondary role in the pathogenesis of PROM.
In 2001, the article Frequency of premature rupture of membranes in preterm labor and evaluation of short and long term management protocols in the labor and delivery room of the Honduran Institute of Social Security was published, which reported a prevalence of 20% of this condition in the study population.7% of this condition in the population studied, a situation that has improved and by 2016 the national document on Initial management and referral of obstetric and neonatal complications was adopted, which includes premature rupture of membranes and establishes a prevalence of 10% of pregnancies and 20% of cases occur in preterm gestations.
PROM in preterm pregnancies is the cause of one third of preterm births and 10% of perinatal deaths; it is also associated with an increase in maternal infectious morbidity due to chorioamnionitis and puerperal infection, constituting a problem for the national health system.
The present research is aimed at the interpretation and analysis of the effects observed in two groups of pregnant women diagnosed with premature rupture of membranes after the administration of cranberry extract, hibiscus and vitamin C in comparison with a group that will be administered placebo, which is consider important to know in view of the high prevalence of this pathology in our environment, since through the results new guidelines could be developed in its management that are cost effective and adapted to the availability of our institutional resources and to the condition of each patient.
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Francisco Morazán Department
-
Tegucigalpa, Francisco Morazán Department, Honduras, 11101
- Hospital Escuela
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cranberry, hibiscus and vitamin c extracts
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
|
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
|
|
Placebo Comparator: Starch
One capsule of Starch per day for 10 days
|
Starch one capsule per day for 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of latency
Time Frame: Since intervention until delivery, assessed up to 48 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neonatal complications
Time Frame: Since intervention until neonatal discharge, assessed up to 28 days.
|
incidence of neonatal complications (APGAR<7 at 5 minutes, admission to neonatal ICU, respiratory distress syndrome, periventricular leukomalacia and necrotizing enterocolitis)
|
Since intervention until neonatal discharge, assessed up to 28 days.
|
|
maternal complications
Time Frame: Since intervention until maternal discharge, assessed up to 30 days.
|
incidence of maternal complications (puerperal fever, postpartum endometritis)
|
Since intervention until maternal discharge, assessed up to 30 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Ricardo A. Gutierrez Ramirez, MD, MSc., Universidad Nacional Autonoma de Honduras
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2025
Primary Completion (Actual)
July 31, 2025
Study Completion (Actual)
August 31, 2025
Study Registration Dates
First Submitted
January 13, 2025
First Submitted That Met QC Criteria
January 16, 2025
First Posted (Actual)
January 22, 2025
Study Record Updates
Last Update Posted (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
August 30, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PGO-UNAH-48-5-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
It is not necessary, none of the 18 HIPAA identifiers will be placed
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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