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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00787813
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : November 20, 2008
Information provided by:
Assiut University

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.

Condition or disease Intervention/treatment Phase
Cervical Cerclage Drug: N-Acetyl Cysteine Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00787813

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Women's Health Center
Assiut, Egypt, 71516
Sponsors and Collaborators
Assiut University
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Principal Investigator: AHMED M NASR, MD Women's Health Center, Assiut University, EGYPT
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Ezat Hamed Sayed, Department of Obstetrics & Gynecology Identifier: NCT00787813    
Other Study ID Numbers: NAC after cerclage
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: November 20, 2008
Last Verified: November 2008
Keywords provided by Assiut University:
N-acetyl cysteine (NAC)
Cervical cerclage
cervical cerclage for cervical insufficiency
Additional relevant MeSH terms:
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Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs