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

Primary Purpose

PPROM

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
pomegranate
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PPROM focused on measuring PPROM, PREGNANCY, POMEGRANATE, OXIDATIVE STRESS

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pomegranate

Arm Description

The women in this group will drink pomegranate juice

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time interval from PPROM to delivery
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).
time interval from PPROM to delivery
following birth the time interval from PPROM to delivey will be assessed, also RDS, fetal Ph and other neonatal complications

Full Information

First Posted
February 16, 2014
Last Updated
February 20, 2014
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02069587
Brief Title
Pomegranate to Reduce Maternal and Fetal Oxidative Stress and to Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of Membranes
Official Title
Pomegranate to Reduce Maternal and Fetal Oxidative Stress and to Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of Membranes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PPROM
Keywords
PPROM, PREGNANCY, POMEGRANATE, OXIDATIVE STRESS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pomegranate
Arm Type
Experimental
Arm Description
The women in this group will drink pomegranate juice
Intervention Type
Dietary Supplement
Intervention Name(s)
pomegranate
Other Intervention Name(s)
Pomegranate juice
Primary Outcome Measure Information:
Title
Maternal and fetal oxidative stress
Description
Maternal and fetal oxidative stress will be determined by blood tests.
Time Frame
10 weeks
Title
Maternal and fetal oxidative stress
Description
Maternal blood and umbilical cord blodd will be drawn following delivery and oxidative blood markers inflammatory mediators will be assessed
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Time interval from PPROM to delivery
Description
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).
Time Frame
10 weeks
Title
time interval from PPROM to delivery
Description
following birth the time interval from PPROM to delivey will be assessed, also RDS, fetal Ph and other neonatal complications
Time Frame
10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ron beloosesky, M.D
Phone
011972509205759
Email
tomor2304@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ron beloosesky
Organizational Affiliation
Hillel Yaffe Medical center technion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Balosesky, MD
Phone
972509205759
Email
tomor2304@yahoo.com

12. IPD Sharing Statement

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

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