Pomegranate to Reduce Maternal and Fetal Oxidative Stress and Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of the Membranes
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ClinicalTrials.gov Identifier: NCT01584323 |
Recruitment Status : Unknown
Verified April 2012 by Yuval Ginsberg, MD, Rambam Health Care Campus.
Recruitment status was: Recruiting
First Posted : April 24, 2012
Last Update Posted : April 24, 2012
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In this study the investigators sought to determine the effects of Pomegranate (Natural pomegranate polyphenol (P. granatum L) extract) :
- On the maternal and fetal oxidative stress and inflammation associated with PPROM.
- On the time interval from PPROM to delivery and on fetal Ph and apger score.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preterm Premature Rupture of Membranes Pregnant State | Dietary Supplement: Pomgranate pills Dietary Supplement: Placebo pills | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | April 2015 |
Estimated Study Completion Date : | May 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Pomegranate pills
treatment with pomgranate pills to women suffering preterm premature rupture of membranes
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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
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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 |
- 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) ]
Serum lipid peroxidation
- Serum lipids peroxidation
- Lipid peroxide formation
- Paraoxonase activity measurements
- 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) ]
- Apgar score
- cord PH
- cord CRP levels
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Ages Eligible for Study: | 17 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- pregnancy
- singleton pregnancy
- preterm premature rupture of membranes
- gestational age > 24Wks
Exclusion Criteria:
- gestational age > 24wks
- fetal anomalies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584323
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 |
Principal Investigator: | Ido Solt, M.D | Rambam Health Care Campus |
Responsible Party: | Yuval Ginsberg, MD, M.D, Rambam Health Care Campus |
ClinicalTrials.gov Identifier: | NCT01584323 |
Other Study ID Numbers: |
0231-11-RMB |
First Posted: | April 24, 2012 Key Record Dates |
Last Update Posted: | April 24, 2012 |
Last Verified: | April 2012 |
Preterm premature rupture of membranes pomgranate oxidative stress pregnant women with Preterm premature rupture of membranes |
Premature Birth Fetal Membranes, Premature Rupture Rupture Obstetric Labor, Premature Obstetric Labor Complications |
Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Wounds and Injuries |