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

This study has been completed.
Information provided by:
Assiut University Identifier:
First received: November 7, 2008
Last updated: November 19, 2008
Last verified: November 2008
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:

Further study details as provided by Assiut University:

Primary Outcome Measures:
  • Gestational age at delivery [ Time Frame: 3-6 months ]

Secondary Outcome Measures:
  • Take home babies, neonatal morbidity [ Time Frame: 3-6 months ]

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
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.

Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00787813

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

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

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

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes processed this record on September 19, 2017