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Pomegranate to Reduce Maternal and Fetal Oxidative Stress and Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of the Membranes

NCT01584323 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-04-24

No results posted yet for this study

Summary

In this study the investigators sought to determine the effects of Pomegranate (Natural pomegranate polyphenol (P. granatum L) extract) :

1. On the maternal and fetal oxidative stress and inflammation associated with PPROM.
2. On the time interval from PPROM to delivery and on fetal Ph and apger score.

Conditions

  • Preterm Premature Rupture of Membranes
  • Pregnant State

Interventions

DIETARY_SUPPLEMENT

Pomgranate pills

Treatment arm will receive The POMx pomegranate 1,000 mg capsule a day for maximum of two weeks or until they deliver if occurs before The POMx pomegranate 1,000 mg capsule contains at least 800 mg natural polyphenol using a pomegranate polyphenol standard and is comparable to mg/8 oz juice.(attached is confirmation Similarity of Pomegranate Juice and POMx Polyphenols)

DIETARY_SUPPLEMENT

Placebo pills

The placebo group will receive placebo pills , for maximum of two weeks or until they deliver if occurs before The palecbo capsule contains gelatin and lactose. The capsuls are manufactured by the hospital pharmacy.All the components are medically approved fot use during pregnancy

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Ido Solt, M.D · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-04-30
Completion
2015-05-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01584323 on ClinicalTrials.gov