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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

NCT01266928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2012-02-07

No results posted yet for this study

Summary

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.

Conditions

  • Preterm Premature Rupture of Membranes

Interventions

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)

Sponsors & Collaborators

  • Erzincan Military Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266928 on ClinicalTrials.gov