- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01266928
Does Vitamins C and E Supplementation of After Preterm Rupture of Membranes Prolong the Duration of Latency? A Prospective Randomized Controlled Study
Preterm premature rupture of membranes (PPROM) is a complication affecting 3-4.5% of all pregnancies. PPROM is the main known cause of preterm delivery and is associated worldwide with increased rates of neonatal and maternal morbidity and mortality. Despite its frequency, very little is known about its pathophysiologic mechanisms. Mechanical strength is provided to fetal membranes by an extracellular collagen matrix. Types I, II, III and IV are the main collagen types in these membranes. Studies have shown that total collagen content is reduced in the amnion of women with preterm PROM.
Vitamin C is involved in the metabolism of collagen and has been proposed to play an important role in the maintenance of the integrity of the chorioamniotic membranes. Vitamin E may play a synergic role with vitamin C, increasing the antioxidant capacity against reactive oxygen. Woods et al hypothesized that an increase in dietary consumption or supplementation of vitamin C and E during pregnancy might reduce the risk of that portion of preterm PROM that may be mediated by oxidative injury to fetal membranes. Plessinger et al report that pretreatment of human amnion-chorion with vitamins C and E prevents hypochlorous acid-induced membrane damage.
Borna et al. reported a randomized, double-blind controlled study of vitamin C and E supplementation, in which women with preterm rupture of membranes and singleton gestations at 26 to 34 weeks were randomized to vitamin C and E supplementation or placebo. Supplementation with vitamin C and E were associated with longer latency before delivery. However, the sample size in this study was very small.
The aim of this study was to evaluate the effect of supplementation with vitamins C and E after preterm premature rupture of membranes. We hypothesised that supplementation vitamins C and E may be effective in decreasing oxidative stress and increasing the latency period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Bakırkoy
-
İstanbul, Bakırkoy, Turkey, 34142
- Bakırkoy Women and Children Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with a single nonanomalous fetus and PPROM at ≥ 24.0 and ≤ 34.0 weeks' gestation.
Exclusion Criteria:
fetus with anomalies, chorioamnionitis, experienced PPROM within 14 days of either amniocentesis or cervical cerclage placement, multiple gestation, obstetrical indication for immediate delivery, delivery within 24 h of admission intrauterine fetal death at the time of presentation.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: vitaminCE
Eligible and consenting women were randomly assigned to capsules containing a combination of 1,000 mg vitamin C (ascorbic acid) and 400 international units of vitamin E (RRR alpha tocopherol acetate)
|
Eligible and consenting women were randomly assigned to capsules containing a combination of 1,000 mg vitamin C (ascorbic acid) and 400 international units of vitamin E (RRR alpha tocopherol acetate)
|
No Intervention: no drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
latency until delivery
Time Frame: 7 days
|
The primary outcome was the latency until delivery
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postpartum endometritis rate, early onset neonatal sepsis rate,
Time Frame: days
|
Other outcomes were the birth weight, mode of delivery, occurrence of clinical chorioamnionitis, postpartum endometritis, early onset neonatal sepsis, grade 3-4 intraventricular haemorrhage (IVH), stage 2-3 necrotizing enterocolitis (NEC), admission to intensive care unit (ICU), duration of stay in an intensive care unit and respiratory distress syndrome.
|
days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Rupture
- Premature Birth
- Fetal Membranes, Premature Rupture
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Ascorbic Acid
Other Study ID Numbers
- gungorduk10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Preterm Premature Rupture of Membranes
-
Thomas Jefferson UniversityUnknownPreterm Premature Rupture of MembranesUnited States
-
Western Galilee Hospital-NahariyaNot yet recruitingPreterm Labor With Preterm Delivery | Premature Rupture of Membranes Prolonged
-
Chelsea and Westminster NHS Foundation TrustSPD Development Company Limited; Borne CharityRecruitingPreterm Birth | Preterm Labor | Preterm Birth Complication | Preterm Premature Rupture of Membrane | Preterm PregnancyUnited Kingdom
-
Ain Shams Maternity HospitalCompletedManagement of Preterm Prelabor Rupture of MembranesEgypt
-
Woman'sRecruitingPreterm Birth | Preterm Labor | Rupture of Membranes; Premature | Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture) | Rupture of Membranes; Premature, Affecting Fetus | Preterm PROM (Pregnancy)United States
-
Seoul National University HospitalCompletedPreterm Labor | Preterm Premature Rupture of Membrane (PPROM)Korea, Republic of
-
University of PennsylvaniaCompletedWomen Admitted to Labor and Delivery for the Management of Preterm Labor and/or Preterm Premature Rupture of Membranes (PPROM)United States
-
Regional Obstetrical ConsultantsTerminatedPreterm Premature Rupture of MembranesUnited States
-
Ain Shams Maternity HospitalAin Shams UniversityUnknownPreterm Premature Rupture of MembranesEgypt
-
Eastern Virginia Medical SchoolNot yet recruitingPreterm Premature Rupture of Membrane
Clinical Trials on vitamine C and E
-
Centre Medicina Esportiva i Osteopatia, SpainCompletedOxidative Stress | Adverse Effects | Ascorbic AcidSpain
-
Swiss Federal Institute of TechnologyCompletedMetabolic SyndromeSwitzerland
-
Lovisenberg Diakonale HospitalUllevaal University Hospital; Zimmer Biomet; Helse Sor-OstUnknownOsteoarthritis | Primary ArthrosisNorway
-
Imperial Brands PLCCompleted
-
Hospital General Universitario ElcheCompleted
-
Gilead SciencesCompletedHIV Infections | HIVUnited States, United Kingdom, Sweden, France, Puerto Rico, Netherlands, Italy, Portugal, Canada, Mexico, Dominican Republic
-
Gilead SciencesCompletedHIV Infections | Acquired Immunodeficiency SyndromeUnited States, Puerto Rico
-
Gilead SciencesCompletedHIV Infections | HIVUnited States, Spain, Switzerland, Canada, Thailand, Puerto Rico, Australia, Austria, Belgium, Italy, Japan, United Kingdom
-
Mohammad Hassan EftekhariShiraz University of Medical SciencesCompleted
-
University of California, Los AngelesGilead SciencesCompletedHIV/AIDS | Mitochondrial Alteration | Antiviral Toxicity | Antiviral Drug Adverse ReactionUnited States