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

NCT ID: NCT02069587

Last Updated: 2014-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-04-30

Brief Summary

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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

Detailed Description

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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

Conditions

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PPROM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Pomegranate

The women in this group will drink pomegranate juice

Group Type EXPERIMENTAL

pomegranate

Intervention Type DIETARY_SUPPLEMENT

Interventions

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pomegranate

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Pomegranate juice

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ron beloosesky

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical center technion

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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ron beloosesky, M.D

Role: CONTACT

011972509205759

Facility Contacts

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Ron Balosesky, MD

Role: primary

972509205759

Other Identifiers

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0074-13HYMC

Identifier Type: -

Identifier Source: org_study_id

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