Fetal Membranes, Premature RuptureNCT00247104
The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
A study testing Cranberries - Vaccinium macrocarpon in people with Fetal Membranes, Premature Rupture and Premature Birth, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Cranberries have been proved to reduce the rate of urinary tract infections in a population of women with recurrent urinary tract infections in previous studies. The purpose of the study is to examine the efficacy of cranberries in pregnant women with preterm premature rupture of membranes in a)prolonging the latent… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Membranes, Premature Rupture, Premature Birth
- What is being tested?
- Cranberries - Vaccinium macrocarpon
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- May 2007to Feb 2008
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Proven premature rupture of membranes
- less than 35 weeks of gestation with good obstetrical dating
- no suspicion of amnionitis
- signed informed consent
Who cannot join
- Known sensitivity / allergy to cranberries
- Women treated with warfarin
- Drug intolerance
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Cranberries have been proved to reduce the rate of urinary tract infections in a population of women with recurrent urinary tract infections in previous studies. The purpose of the study is to examine the efficacy of cranberries in pregnant women with preterm premature rupture of membranes in a)prolonging the latent period (=the time period between the time the water broke and delivery of the fetus) and b)reduction of infectious morbidity of both the mother and infant.
Read the detailed description
Preterm premature rupture of membranes (PPROM) complicates 2-3.5% of pregnancies and precipitates labor in 30-40% of preterm deliveries. The common practice in early PPROM with no evidence of chorioamnionitis is admission for close surveillance, antibiotic treatment and steroids for fetal lung maturation (until 32 weeks gestation. Intraamniotic infection is evident in up to 75% of women who develop labor during admission. The infection is for the most an ascending infection.
Cranberries have been recognized by the American Indians as a natural means for preventing urinary tract infection. The mechanism of action includes acidification of urine and inhibition of adhesion of pili-harboring bacteria to the transitional epithelium of the urinary tract.
We assume that cranberries will lower the rate of maternal urinary tract infection. Moreover, the active ingredients will pass transplacentally to the fetus, will be secreted in its urine hence, in the amniotic fluid. The active substances would coat the vagina and bring about their effect also in that environment. Having in mind that most if not all chorioamnionitis infections are caused by ascending infection, the cranberries might lengthen the latent period and reduce infectious maternal and neonatal morbidity.
- Being tested
- Cranberries - Vaccinium macrocarpon
- Keywords
- Urinary tract infection, Endometritis, Respiratory Distress Syndrome, Necrotizing enterocolitis, Intraventricular hemorrhage, Latent period, Neonatal infection
- Medical subject headings
- Fetal Membranes, Premature Rupture, Premature Birth, Urinary Tract Infections, Endometritis, Respiratory Distress Syndrome, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberries - Vaccinium macrocarponDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Length (in days) of the latent period
Neonatal infection
Respiratory distress
Admission to NICU (in days)
Neonatal complications rate (NEC, IVH etc)
Maternal infections (uterus, UTI)
Secondary outcomes (3)
Urinary and vaginal flora before and after treatment
Vaginal pH before and after treatment
Amniotic fluid pH before and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startMay 2007
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fetal Membranes, Premature RuptureStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Drorit Hochner-Celnikier, MD, Study director, Hadassah Medical OrganizationUriel Elchalal, MD, Study director, Hadassah Medical OrganizationHagit Daum, MD, Principal investigator, Hadassah Medical OrganizationShay Porat, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247104
- Sponsor's protocol ID
- CRANBERRIES-HMO-CTIL
- Status last verified
- Mar 2006
- First submitted
- 31 Oct 2005
- Last updated
- 11 Apr 2007
- Results posted
- No
Publications
Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2004;(2):CD001321. doi: 10.1002/14651858.CD001321.pub3.
PubMed 15106157Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
PubMed 37947276Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
PubMed 37068952
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Cranberries in Women With Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT00247104
- Acronym / sponsor ID
- CRANBERRIES-HMO-CTIL
- Keywords
- Urinary tract infection, Endometritis, Respiratory Distress Syndrome, Necrotizing enterocolitis, Intraventricular hemorrhage, Latent period, Neonatal infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2007
- Study completion
- Feb 2008 (estimated)
- First posted
- 1 Nov 2005 (estimated)
- 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.
Cranberries have been proved to reduce the rate of urinary tract infections in a population of women with recurrent urinary tract infections in previous studies. The purpose of the study is to examine the efficacy of cranberries in pregnant women with preterm premature rupture of membranes in a)prolonging the latent period (=the time period between the time the water broke and delivery of the fetus) and b)reduction of infectious morbidity of both the mother and infant.
Detailed description
Preterm premature rupture of membranes (PPROM) complicates 2-3.5% of pregnancies and precipitates labor in 30-40% of preterm deliveries. The common practice in early PPROM with no evidence of chorioamnionitis is admission for close surveillance, antibiotic treatment and steroids for fetal lung maturation (until 32 weeks gestation. Intraamniotic infection is evident in up to 75% of women who develop labor during admission. The infection is for the most an ascending infection.
Cranberries have been recognized by the American Indians as a natural means for preventing urinary tract infection. The mechanism of action includes acidification of urine and inhibition of adhesion of pili-harboring bacteria to the transitional epithelium of the urinary tract.
We assume that cranberries will lower the rate of maternal urinary tract infection. Moreover, the active ingredients will pass transplacentally to the fetus, will be secreted in its urine hence, in the amniotic fluid. The active substances would coat the vagina and bring about their effect also in that environment. Having in mind that most if not all chorioamnionitis infections are caused by ascending infection, the cranberries might lengthen the latent period and reduce infectious maternal and neonatal morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Proven premature rupture of membranes
- less than 35 weeks of gestation with good obstetrical dating
- no suspicion of amnionitis
- signed informed consent
Key exclusion criteria (3 listed)
- Known sensitivity / allergy to cranberries
- Women treated with warfarin
- Drug intolerance
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 |
|---|---|---|
| Cranberries - Vaccinium macrocarpon | Drug | – |
Primary outcome
Length (in days) of the latent period
Neonatal infection
Respiratory distress
Admission to NICU (in days)
Neonatal complications rate (NEC, IVH etc)
Maternal infections (uterus, UTI)
3 secondary outcomes
Urinary and vaginal flora before and after treatment
Vaginal pH before and after treatment
Amniotic fluid pH before and after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2007.
- Background: PubMed 15106157Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2004;(2):CD001321. doi: 10.1002/14651858.CD001321.pub3.
- Derived from this study: PubMed 37947276Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.
- Derived from this study: PubMed 37068952Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.
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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.
Drorit Hochner-Celnikier, MD study director
Hadassah Medical Organization
Uriel Elchalal, MD study director
Hadassah Medical Organization
Hagit Daum, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberries - Vaccinium macrocarpon in people with Fetal Membranes, Premature Rupture and Premature Birth, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Apr 2007. 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shay Porat, MD (00 972 2 5844222, shay.porat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length (in days) of the latent period. The study lists 6 primary outcomes in all. 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 NCT00247104, which also lists 3 linked publications.
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 11 Apr 2007.