NCT02069587

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 24, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

February 16, 2014

Last Update Submit

February 20, 2014

Conditions

PPROM

Keywords

PPROMPREGNANCYPOMEGRANATEOXIDATIVE STRESS

Outcome Measures

Primary Outcomes (2)

  • Maternal and fetal oxidative stress

    Maternal and fetal oxidative stress will be determined by blood tests.

    10 weeks

  • Maternal and fetal oxidative stress

    Maternal blood and umbilical cord blodd will be drawn following delivery and oxidative blood markers inflammatory mediators will be assessed

    10 weeks

Secondary Outcomes (2)

  • Time interval from PPROM to delivery

    10 weeks

  • time interval from PPROM to delivery

    10 weeks

Study Arms (1)

Pomegranate

EXPERIMENTAL

The women in this group will drink pomegranate juice

Dietary Supplement: pomegranate

Interventions

pomegranateDIETARY_SUPPLEMENT
Also known as: Pomegranate juice
Pomegranate

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Study Officials

  • ron beloosesky

    Hillel Yaffe Medical center technion

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ron beloosesky, M.D

CONTACT

011972509205759tomor2304@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2014

First Posted

February 24, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

February 24, 2014

Record last verified: 2014-01

Locations

IL(1)