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

PPROM Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02069587
• Other study ID #: 0074-13HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: February 16, 2014
• Last updated: February 20, 2014
• Start date: February 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2014
• Source: Hillel Yaffe Medical Center
• Contact: ron beloosesky, M.D
• Phone: 011972509205759
• Email: tomor2304[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• PPROM

Intervention

Dietary Supplement:
• pomegranate

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal and fetal oxidative stress	Maternal and fetal oxidative stress will be determined by blood tests.	10 weeks	No
Primary	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	No
Secondary	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	No
Secondary	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	No