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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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PPROM

Intervention / Treatment
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* Dietary Supplement: pomegranate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pomegranate<br>The women in this group will drink pomegranate juice | Dietary Supplement: pomegranate<br> <br> * Other names: Pomegranate juice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 10 weeks | 
| 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 | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OXIDATIVE STRESS, PPROM, PREGNANCY, POMEGRANATE