The Use of Cranberries in Women With Preterm Premature Rupture of Membranes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00247104
First received: October 31, 2005
Last updated: April 10, 2007
Last verified: March 2006
  Purpose

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.


Condition Intervention
Fetal Membranes, Premature Rupture
Premature Birth
Drug: Cranberries - Vaccinium macrocarpon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Use of Cranberries in Women With Preterm Premature Rupture of Membranes

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Urinary and vaginal flora before and after treatment
  • Vaginal pH before and after treatment
  • Amniotic fluid pH before and after treatment

Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Study Completion Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Proven premature rupture of membranes
  • less than 35 weeks of gestation with good obstetrical dating
  • no suspicion of amnionitis
  • signed informed consent

Exclusion Criteria:

  • Known sensitivity / allergy to cranberries
  • Women treated with warfarin
  • Drug intolerance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247104

Contacts
Contact: Shay Porat, MD 00 972 2 5844222 shay.porat@gmail.com

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: Drorit Hochner-Celnikier, MD Hadassah Medical Organization
Study Director: Uriel Elchalal, MD Hadassah Medical Organization
Principal Investigator: Hagit Daum, MD Hadassah Medical Organization
Principal Investigator: Shay Porat, MD Hadassah Medical Organization
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00247104     History of Changes
Other Study ID Numbers: CRANBERRIES-HMO-CTIL
Study First Received: October 31, 2005
Last Updated: April 10, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Urinary tract infection
Endometritis
Respiratory Distress Syndrome
Necrotizing enterocolitis
Intraventricular hemorrhage
Latent period
Neonatal infection

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Premature Birth
Rupture
Obstetric Labor Complications
Pregnancy Complications
Obstetric Labor, Premature
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014