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Does Vitamins C and E Supplementation of After Preterm Rupture of Membranes Prolong the Duration of Latency? A Prospective Randomized Controlled Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kemal GUNGORDUK, Erzincan Military Hospital
ClinicalTrials.gov Identifier:
NCT01266928
First received: December 20, 2010
Last updated: February 6, 2012
Last verified: February 2012

December 20, 2010
February 6, 2012
January 2011
November 2011   (final data collection date for primary outcome measure)
latency until delivery [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
The primary outcome was the latency until delivery
Same as current
Complete list of historical versions of study NCT01266928 on ClinicalTrials.gov Archive Site
postpartum endometritis rate, early onset neonatal sepsis rate, [ Time Frame: days ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Does Vitamins C and E Supplementation of After Preterm Rupture of Membranes Prolong the Duration of Latency? A Prospective Randomized Controlled Study
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Preterm Premature Rupture of Membranes
Drug: vitamine C and E
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)
  • 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)
    Intervention: Drug: vitamine C and E
  • No Intervention: no drug
    no drug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
244
November 2011
November 2011   (final data collection date for primary outcome measure)

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.

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Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01266928
gungorduk10
Yes
Kemal GUNGORDUK, Erzincan Military Hospital
Erzincan Military Hospital
Not Provided
Not Provided
Erzincan Military Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP