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N-Acetyl Cysteine After Cervical Cerclage (NAC-CC)

This study has been completed.
Sponsor:
Information provided by:
Assiut University
ClinicalTrials.gov Identifier:
NCT00787813
First received: November 7, 2008
Last updated: November 19, 2008
Last verified: November 2008
History of Changes
  Purpose

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.


Condition Intervention
Cervical Cerclage
 Drug: N-Acetyl Cysteine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assiut University:

Primary Outcome Measures:
  • Gestational age at delivery [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Take home babies, neonatal morbidity [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
N-Acetyl Cysteine
 Drug: N-Acetyl Cysteine
oral daily dose of 0.6 g of N-acetyl cysteine in effervescent form
Other Name: placebo
Placebo Comparator: 2
placebo
 Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787813

Locations
Egypt
Women's Health Center
Assiut, Egypt, 71516
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: AHMED M NASR, MD Women's Health Center, Assiut University, EGYPT
  More Information

Publications:

Responsible Party: Prof. Ezat Hamed Sayed, Department of Obstetrics & Gynecology
ClinicalTrials.gov Identifier: NCT00787813     History of Changes
Other Study ID Numbers: NAC after cerclage
Study First Received: November 7, 2008
Last Updated: November 19, 2008
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Assiut University:
N-acetyl cysteine (NAC)
Cervical cerclage
cervical cerclage for cervical insufficiency

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
 Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on June 18, 2013