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
  Purpose

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.


Condition Intervention Phase
Preterm Premature Rupture of Membranes
Drug: vitamine C and E
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Erzincan Military Hospital:

Primary Outcome Measures:
  • latency until delivery [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    The primary outcome was the latency until delivery


Secondary Outcome Measures:
  • 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.


Enrollment: 244
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)
No Intervention: no drug
no drug

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266928

Locations
Turkey
Bakırkoy Women and Children Hospital
İstanbul, Bakırkoy, Turkey, 34142
Sponsors and Collaborators
Erzincan Military Hospital
  More Information

No publications provided

Responsible Party: Kemal GUNGORDUK, M.D, Erzincan Military Hospital
ClinicalTrials.gov Identifier: NCT01266928     History of Changes
Other Study ID Numbers: gungorduk10
Study First Received: December 20, 2010
Last Updated: February 6, 2012
Health Authority: United States: Food and Drug Administration
Turkey: Ethics Committee
Turkey: Ministry of Health

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Ascorbic Acid
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 14, 2014