Pomegranate to Reduce Maternal and Fetal Oxidative Stress and to Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of Membranes
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Maternal and fetal oxidative stress
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Pomegranate
The women in this group will drink pomegranate juice
Intervention: pomegranate (Dietary Supplement)
Outcomes
Primary Outcomes
Maternal and fetal oxidative stress
Time Frame: 10 weeks
Maternal and fetal oxidative stress will be determined by blood tests.
Secondary Outcomes
- Time interval from PPROM to delivery(10 weeks)
- time interval from PPROM to delivery(10 weeks)