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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Yuval Ginsberg, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01584323
First received: April 16, 2012
Last updated: April 22, 2012
Last verified: April 2012
  Purpose

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.

Condition Intervention
Preterm Premature Rupture of Membranes
Pregnant State
Dietary Supplement: Pomgranate pills
Dietary Supplement: Placebo pills

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pomegranate to Reduce Maternal and Fetal Oxidative Stress and Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of the Membranes

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Oxidative Stress [ Time Frame: Measurments will be first taken at the day of admission (for the mother) and will be assessed immediatly after delivery (mother and newborn) ] [ Designated as safety issue: Yes ]

    Serum lipid peroxidation

    1. Serum lipids peroxidation
    2. Lipid peroxide formation
    3. Paraoxonase activity measurements


Secondary Outcome Measures:
  • Obstetrical outcomes [ Time Frame: Measurments will be first taken at the day of admission (for the mother) and will be assessed immediatly after delivery (mother and newborn) ] [ Designated as safety issue: Yes ]
    1. Apgar score
    2. cord PH
    3. cord CRP levels


Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pomegranate pills
treatment with pomgranate pills to women suffering preterm premature rupture of membranes
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)

Placebo Comparator: placebo pills
treatment with placebo to women with preterm premature rupture of membranes
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnancy
  • singleton pregnancy
  • preterm premature rupture of membranes
  • gestational age > 24Wks

Exclusion Criteria:

  • gestational age > 24wks
  • fetal anomalies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584323

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Yuval Ginsberg, M.D    +972502061395    y_ginsberg@rambam.health.gov.il   
Contact: Ido Solt, M.D    +972502062681    I_solt@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ido Solt, M.D Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Yuval Ginsberg, MD, M.D, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01584323     History of Changes
Other Study ID Numbers: 0231-11-RMB
Study First Received: April 16, 2012
Last Updated: April 22, 2012
Health Authority: Israel: Ministry of Health
Israel: Rambam Health Care Campus

Keywords provided by Rambam Health Care Campus:
Preterm premature rupture of membranes
pomgranate
oxidative stress
pregnant women with Preterm premature rupture of membranes

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014