PPROMNCT02069587
Pomegranate to Reduce Maternal and Fetal Oxidative Stress and to Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of Membranes
A study testing pomegranate in people with PPROM, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- PPROM
- What is being tested?
- pomegranate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients
- admitted with PPROM
- between 24-32 weeks of gestation
Who cannot join
- Women with contractions
- abruption
- monochorionic multiple pregnancy
- abnormal (non-reassuring) cardiotocogram
- meconium-stained amniotic fluid
- signs of intrauterine infection
Show all 10Show fewer
- major fetal anomalies
- hemolysis
- elevated liver enzymes
- low platelets (HELLP syndrome); or severe preeclampsia.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Ron Balosesky, MD, 972509205759, tomor2304@yahoo.com
About this study
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
Read the 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
- Conditions
- PPROM
- Being tested
- pomegranate
- Keywords
- PPROM, PREGNANCY, POMEGRANATE, OXIDATIVE STRESS
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pomegranateDietary supplement
Also called Pomegranate juice
| Study group | Role | What they receive |
|---|---|---|
| Pomegranate | Experimental | The women in this group will drink pomegranate juice Receives: Dietary Supplement: pomegranate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal and fetal oxidative stress
Maternal and fetal oxidative stress will be determined by blood tests.
Measured: 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
Measured: 10 weeks
Secondary outcomes (2)
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).
Measured: 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
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPROMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ron beloosesky, Principal investigator, Hillel Yaffe Medical center technion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069587
- Sponsor's protocol ID
- 0074-13HYMC
- Status last verified
- Jan 2014
- First submitted
- 16 Feb 2014
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pomegranate to Reduce Maternal and Fetal Oxidative Stress and to Improve Outcome in Pregnancies Complicated With Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT02069587
- Acronym / sponsor ID
- 0074-13HYMC
- Conditions
- PPROM
- Keywords
- PPROM, PREGNANCY, POMEGRANATE, OXIDATIVE STRESS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pomegranate | Experimental | Dietary Supplement: pomegranateThe women in this group will drink pomegranate juice |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant patients
- admitted with PPROM
- between 24-32 weeks of gestation
Key exclusion criteria (10 listed)
- Women with contractions
- abruption
- monochorionic multiple pregnancy
- abnormal (non-reassuring) cardiotocogram
- meconium-stained amniotic fluid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pomegranateAlso: Pomegranate juice | Dietary supplement | Pomegranate |
Primary outcome
Maternal and fetal oxidative stress
Time frame: 10 weeks
Maternal and fetal oxidative stress will be determined by blood tests.
Maternal and fetal oxidative stress
Time frame: 10 weeks
Maternal blood and umbilical cord blodd will be drawn following delivery and oxidative blood markers inflammatory mediators will be assessed
2 secondary outcomes
Time interval from PPROM to delivery
Time frame: 10 weeks
time interval from PPROM to delivery
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
Related trials for PPROM
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Active, not recruitingPhase 3
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Premature Rupture of Membrane
Not yet recruitingObservational study
Preterm Parturation Study
Preterm Parturation, Preterm Premature Rupture of Membranes (PPROM)
Not yet recruitingObservational study
Prediction of Latency Interval in Patients With Preterm Prelabor Rupture of Membranes
Preterm Prelabor Rupture of Membranes (PPROM)
Recruiting
Effects of Emotional Freedom Technique and Music Therapy in High-Risk Pregnancy
Preterm Premature Rupture of Membranes (PPROM), Premature Rupture of Membranes (PROM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ron beloosesky principal investigator
Hillel Yaffe Medical center technion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pomegranate in people with PPROM, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ron beloosesky, M.D (011972509205759, tomor2304@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal and fetal oxidative stress (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.