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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00247104
• Other study ID #: CRANBERRIES-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2005
• Last updated: April 10, 2007
• Start date: May 2007
• Est. completion date: February 2008

Study information

• Verified date: March 2006
• Source: Hadassah Medical Organization
• Contact: Shay Porat, MD
• Phone: 00 972 2 5844222
• Email: shay.porat[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Rupture

Intervention

Drug:
• Cranberries - Vaccinium macrocarpon

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Jepson RG, Mihaljevic L, Craig J. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2004;(2):CD001321. Review. Update in: Cochrane Database Syst Rev. 2008;(1):CD001321. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length (in days) of the latent period
Primary	Neonatal infection
Primary	Respiratory distress
Primary	Admission to NICU (in days)
Primary	Neonatal complications rate (NEC, IVH etc)
Primary	Maternal infections (uterus, UTI)
Secondary	Urinary and vaginal flora before and after treatment
Secondary	Vaginal pH before and after treatment
Secondary	Amniotic fluid pH before and after treatment