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Clinical Trials/NCT00787813
NCT00787813CompletedNot Applicable

Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial

Assiut University1 site in 1 country100 target enrollmentStarted: June 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Gestational age at delivery
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of the study is to evaluate the effect of N-acetyl cysteine (NAC) on pregnancy outcome in women undergoing cervical cerclage for cervical insufficiency.

Detailed Description

A randomized controlled clinical trial to be carried out in a university-affiliated tertiary center.Participating women will be randomized into two groups: Group A will be given an oral daily dose of 0.6 g of NAC in effervescent form; group B, serving as controls, will not receive NAC.The two groups will then be compared according to pregnancy outcome.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •women with history suggestive of cervical insufficiency together with ultrasound findings suggestive of cervical insufficiency undergoing elective cervical cerclage between the 11th and 12th gestational week.
  • •singelton viable fetus

Exclusion Criteria

  • •women tested positive for bacterial vaginosis
  • •women currently with threatened abortion (vaginal bleeding or uterinecramps)
  • •age older than 35 years or younger than 20 years
  • •unwillingness to participate
  • •irregular and/or uncertain menstrual dates
  • •rupture of membranes
  • •previous cesarean delivery
  • •possible risks for preterm birth in the current or previous pregnancy such as twin pregnancy, IUFD, malpresentation, known fetal anomaly, progesterone or heparin treatment during the current pregnancy, hypertension, and/or seizure disorders.
  • •women with contra indications for cervical cerclage or anesthesia.

Arms & Interventions

1

Active Comparator

N-Acetyl Cysteine

Intervention: N-Acetyl Cysteine (Drug)

2

Placebo Comparator

placebo

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Gestational age at delivery

Time Frame: 3-6 months

Secondary Outcomes

  • Take home babies, neonatal morbidity(3-6 months)

Investigators

Sponsor Class
Other

Study Sites (1)

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