Premature Rupture of MembranesSBERRYNCT06788132
Cranberry, Hibiscus, and Vitamin C Extracts Versus Placebo in Latency of Premature Rupture of Membranes.
A study testing Cranberry products in people with Premature Rupture of Membranes and Fetal Complications, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Rupture of Membranes, Fetal Complications
- What is being tested?
- Cranberry products
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteHonduras
- Study dates
- 30 Jan 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
About this study
Official title: 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.
Read the 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.
- Being tested
- Cranberry products, Placebo
- Keywords
- Cranberry, Hibiscus, Vitamin C, Premature Rupture of membranes
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry productsCombination 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
PlaceboOther
Starch one capsule per day for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: Cranberry products |
| Starch | Placebo comparator | One capsule of Starch per day for 10 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of latency
change in the duration of the latency of premature rupture of membranes in number of days
Measured: Since intervention until delivery, assessed up to 48 hours
Secondary outcomes (2)
neonatal complications
incidence of neonatal complications (APGAR<7 at 5 minutes, admission to neonatal ICU, respiratory distress syndrome, periventricular leukomalacia and necrotizing enterocolitis)
Measured: Since intervention until neonatal discharge, assessed up to 28 days.
maternal complications
incidence of maternal complications (puerperal fever, postpartum endometritis)
Measured: Since intervention until maternal discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start30 Jan 2025
- Primary completion31 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Rupture of MembranesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, prospective, prospective, single-center, double-blind, parallel group, efficacy and superiority clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Honduras
- Responsible party
- Sponsor-investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A. Gutierrez Ramirez, MD, MSc., Study director, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788132
- Sponsor's protocol ID
- PGO-UNAH-48-5-2025
- Acronym
- SBERRY
- Status last verified
- Aug 2025
- First submitted
- 13 Jan 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not necessary, none of the 18 HIPAA identifiers will be placed
Publications
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.
PubMed 23592317
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranberry, Hibiscus, and Vitamin C Extracts Versus Placebo in Latency of Premature Rupture of Membranes. Randomized Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT06788132
- Acronym / sponsor ID
- SBERRY / PGO-UNAH-48-5-2025
- Keywords
- Cranberry, Hibiscus, Vitamin C, Premature Rupture of membranes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOGUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Honduras
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, controlled, prospective, prospective, single-center, double-blind, parallel group, efficacy and superiority clinical trial
| Arm | Type | Receives |
|---|---|---|
| Cranberry, hibiscus and vitamin c extracts | Experimental | Combination Product: Cranberry products1 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 |
| Starch | Placebo comparator | Other: PlaceboOne capsule of Starch per day for 10 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranberry productsOne 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 | Combination product | Cranberry, hibiscus and vitamin c extracts |
| PlaceboStarch one capsule per day for 10 days | Other | Starch |
Primary outcome
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
2 secondary outcomes
neonatal complications
Time frame: Since intervention until neonatal discharge, assessed up to 28 days.
maternal complications
Time frame: Since intervention until maternal discharge, assessed up to 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 23592317Gungorduk 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.
- Individual participant dataSharing planned: No. It is not necessary, none of the 18 HIPAA identifiers will be placed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A. Gutierrez Ramirez, MD, MSc. study director
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry products in people with Premature Rupture of Membranes and Fetal Complications, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of latency (time frame: Since intervention until delivery, assessed up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06788132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.