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Clinical Trials/NCT01584323
NCT01584323UnknownNot Applicable

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

Rambam Health Care Campus1 site in 1 country100 target enrollmentStarted: April 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Oxidative Stress

Study Overview

Brief Summary

In this study the investigators sought to determine the effects of Pomegranate (Natural pomegranate polyphenol (P. granatum L) extract) :

  1. On the maternal and fetal oxidative stress and inflammation associated with PPROM.
  2. On the time interval from PPROM to delivery and on fetal Ph and apger score.

Detailed Description

Preterm premature rupture of membranes is the rupture of membranes during pregnancy before 37 weeks' gestation. It occurs in 3 percent of pregnancies and is the cause of approximately one third of preterm deliveries. It can lead to significant perinatal morbidity, including respiratory distress syndrome, neonatal sepsis, umbilical cord prolapse, placental abruption, and fetal death.(ref) It increases the risk of prematurity and leads to a number of other perinatal and neonatal complications, including a 1 to 2 percent risk of fetal death.(2) The latent period, which is the time from membrane rupture until delivery, generally is inversely proportional to the gestational age at which PROM occurs. For example, one large study (3) of patients at term revealed that 95 percent of patients delivered within approximately one day of PROM, whereas an analysis of studies(4) evaluating patients with preterm PROM between 16 and 26 weeks' gestation determined that 57 percent of patients delivered within one week, and 22 percent had a latent period of four weeks Numerous risk factors are associated with preterm premature rupture of membrane, lower socioeconomic status, are smokers, have a history of sexually transmitted infections, have had a previous preterm delivery, have vaginal bleeding, or have uterine distension (e.g., polyhydramnios, choriodecidual infection, in many cases the PPROM is associated inflammatory process and increased oxidative stress. Intrauterine inflammation may be associated with, fetal injury preterm birth, low birth weight, and cerebral palsy (5,6,7,8,9). While treatment for PPROM Includes antibiotics it does not aimed to cope with the increased oxidative stress and inflammation that are associated with PPROM and are thought to play important role in the fetal injury Pomegranate juice contains a high concentration of vitamins (C, B1, B2, B3, B5), potassium, Magnesium, Zinc and is a good source for polyphenols (10). Polyphenols molecules have been found to possess antioxidant properties as well as effects on gene expression (11). Recent studies indicate that among foods that contain polyphenols, juice extracted from the pomegranate has the highest concentration of measurable polyphenols (12,13). Pomegranates have shown activity against the cytokine NF-κB and the MAP kinases JNK and ERK, which are critical steps in the cascade of events leading to inflammatory response The NF- κB pathway is activated in response to bacterial infection, and this may explain the effects against bacterial infection (14). Juice consumption may also inhibit viral infection (15).

In a rat animal model pomegranate juice that was given to the dams during pregnancy and lactation period was found as neuroprotective agent to the neonatal mouse brain.(16). Recently Tuuli et al published abstract at the annual meeting of the society of maternal fetal medicine 2011, demonstrating that pomefranate juice (8 oz a day) supplement for the last two weeks to pregnancy, reduced significantly the placental oxidative stress associated with delivery compared to control.

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 we sought to determine the effects of Pomegranate 1. on the maternal and fetal oxidative stress and inflammation associated with PPROM 2. On the time interval from PPROM to delivery and on fetal Ph and apger score.

Study protocol:

All the women admitted with PPROM will receive the usual protocol of the department (Penibrin for two days and Erythromycin for five days)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
17 Years to 45 Years (Child, Adult)
Sex
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

Arms & Interventions

Pomegranate pills

Active Comparator

treatment with pomgranate pills to women suffering preterm premature rupture of membranes

Intervention: Pomgranate pills (Dietary Supplement)

placebo pills

Placebo Comparator

treatment with placebo to women with preterm premature rupture of membranes

Intervention: Placebo pills (Dietary Supplement)

Outcomes

Primary Outcomes

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 1. Serum lipids peroxidation 2. Lipid peroxide formation 3. Paraoxonase activity measurements

Secondary Outcomes

  • Obstetrical outcomes(Measurments will be first taken at the day of admission (for the mother) and will be assessed immediatly after delivery (mother and newborn))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yuval Ginsberg, MD

M.D

Rambam Health Care Campus

Study Sites (1)

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