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

Not Applicable

• Conditions: PPROM

• Registration Number: NCT02069587
• Lead Sponsor: Hillel Yaffe Medical Center

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 Timeline

• Status Verified: 2014-01
• Study Start: 2014-02
• Study First Submitted: 2014-02-16
• Study First Submitted QC: 2014-02-20
• Last Update Submitted: 2014-02-20
• Study First Posted: 2014-02-24
• Last Update Posted: 2014-02-24
• Primary Completion: 2015-02
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal and fetal oxidative stress	10 weeks	Maternal blood and umbilical cord blodd will be drawn following delivery and oxidative blood markers inflammatory mediators will be assessed

Secondary Outcome Measures

Name	Time	Method
Time interval from PPROM to delivery	10 weeks	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).
time interval from PPROM to delivery	10 weeks	following birth the time interval from PPROM to delivey will be assessed, also RDS, fetal Ph and other neonatal complications

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel