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

NCT01584323 | Unknown DMC

• 1 other identifier: 0231-11-RMB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators sought to determine the effects of Pomegranate (Natural pomegranate polyphenol (P. granatum L) extract) :

1. 1.On the maternal and fetal oxidative stress and inflammation associated with PPROM.
2. 2.On the time interval from PPROM to delivery and on fetal Ph and apger score.

Conditions

Preterm Premature Rupture of Membranes; Pregnant State

Keywords

Preterm premature rupture of membranes; pomgranate; oxidative stress; pregnant women with Preterm premature rupture of membranes

Outcome Measures

Primary Outcomes (1)

• Oxidative Stress

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

  Measurments will be first taken at the day of admission (for the mother) and will be assessed immediatly after delivery (mother and newborn)

Secondary Outcomes (1)

• Obstetrical outcomes

  Measurments will be first taken at the day of admission (for the mother) and will be assessed immediatly after delivery (mother and newborn)

Study Arms (2)

Pomegranate pills

ACTIVE COMPARATOR

treatment with pomgranate pills to women suffering preterm premature rupture of membranes

Dietary Supplement: Pomgranate pills

placebo pills

PLACEBO COMPARATOR

treatment with placebo to women with preterm premature rupture of membranes

Dietary Supplement: Placebo pills

Interventions

Pomgranate pills DIETARY_SUPPLEMENT

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)

Pomegranate pills

Placebo pills DIETARY_SUPPLEMENT

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

placebo pills

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• gestational age \> 24wks
• fetal anomalies

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Study Officials

• Ido Solt, M.D

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 24, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

IL (1)