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

February 20, 2014 updated by: Hillel Yaffe Medical Center
Preterm premature rupture of membrane is associated with increased oxidative stress and inflammatory process, enhancing the activity or the availability of antioxidants may modulate the inflammatory response associated with PPROM, thereby reducing oxidative stress and the risk to the fetus. In this study the investigators sought to determine the effects of Pomegranate 1. On the patients (maternal and fetal) oxidative stress and inflammation associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients (fetal )Ph and apger scores

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In this study the investigators sought to determine the effects of Pomegranate 1. On the patients (maternal and fetal )oxidative stress and inflammation associated with PPROM. 2. On the time interval from PPROM to delivery and on the patients (fetal )Ph and apger scores

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant patients
  • admitted with PPROM
  • between 24-32 weeks of gestation

Exclusion Criteria:

  • Women with contractions
  • abruption
  • monochorionic multiple pregnancy
  • abnormal (non-reassuring) cardiotocogram
  • meconium-stained amniotic fluid
  • signs of intrauterine infection
  • major fetal anomalies
  • hemolysis
  • elevated liver enzymes
  • low platelets (HELLP syndrome); or severe preeclampsia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pomegranate
The women in this group will drink pomegranate juice
Dietary supplement: pomegranate
Other Names:
  • Pomegranate juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal and fetal oxidative stress
Time Frame: 10 weeks
Maternal and fetal oxidative stress will be determined by blood tests.
10 weeks
Maternal and fetal oxidative stress
Time Frame: 10 weeks
Maternal blood and umbilical cord blodd will be drawn following delivery and oxidative blood markers inflammatory mediators will be assessed
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time interval from PPROM to delivery
Time Frame: 10 weeks
Time interval from PPROM to delivery, respiratory distress syndrome (RDS), meconium aspiration syndrome, asphyxia, late onset neonatal sepsis, hypoglycemia, necrotizing enterocolitis, hyperbilirubinemia, intraventricular hemorrhage, periventricular leucomalacia, convulsions, other neurological abnormalities, other complications, intrapartum death, total length of hospital stay and admission, and length of stay on neonatal intensive care unit (NICU).
10 weeks
time interval from PPROM to delivery
Time Frame: 10 weeks
following birth the time interval from PPROM to delivey will be assessed, also RDS, fetal Ph and other neonatal complications
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: ron beloosesky, Hillel Yaffe Medical center technion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

February 16, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0074-13HYMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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