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 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266928
• Other study ID #: gungorduk10
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2010
• Last updated: February 6, 2012
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: Erzincan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTurkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Preterm Premature Rupture of Membranes
• Rupture

Intervention

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)

Locations

Country	Name	City	State
Turkey	Bakirkoy Women and Children Hospital	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan Military Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	latency until delivery	The primary outcome was the latency until delivery	7 days	Yes
Secondary	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.	days	Yes