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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

Primary Purpose

Preterm Premature Rupture of Membranes

Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
vitamine C and E
Sponsored by
Erzincan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Premature Rupture of Membranes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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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Sites / Locations

  • Bakırkoy Women and Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

vitaminCE

no drug

Arm Description

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 drug

Outcomes

Primary Outcome Measures

latency until delivery
The primary outcome was the latency until delivery

Secondary Outcome Measures

postpartum endometritis rate, early onset neonatal sepsis rate,
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.

Full Information

First Posted
December 20, 2010
Last Updated
February 6, 2012
Sponsor
Erzincan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01266928
Brief Title
Does Vitamins C and E Supplementation of After Preterm Rupture of Membranes Prolong the Duration of Latency? A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzincan Military Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of Membranes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitaminCE
Arm Type
Active Comparator
Arm Description
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)
Arm Title
no drug
Arm Type
No Intervention
Arm Description
no drug
Intervention Type
Drug
Intervention Name(s)
vitamine C and E
Intervention Description
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)
Primary Outcome Measure Information:
Title
latency until delivery
Description
The primary outcome was the latency until delivery
Time Frame
7 days
Secondary Outcome Measure Information:
Title
postpartum endometritis rate, early onset neonatal sepsis rate,
Description
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.
Time Frame
days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. -
Facility Information:
Facility Name
Bakırkoy Women and Children Hospital
City
İstanbul
State/Province
Bakırkoy
ZIP/Postal Code
34142
Country
Turkey

12. IPD Sharing Statement

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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

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