N-Acetyl Cysteine After Cervical Cerclage

Not Applicable

Completed

• Conditions: Cervical Cerclage
• Interventions: Drug: N-Acetyl Cysteine; Drug: Placebo

• Registration Number: NCT00787813
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-06
• Primary Completion: 2008-10
• Status Verified: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Last Update Submitted: 2008-11-19
• Last Update Posted: 2008-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	N-Acetyl Cysteine	N-Acetyl Cysteine
2	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
Gestational age at delivery	3-6 months

Secondary Outcome Measures

Name	Time	Method
Take home babies, neonatal morbidity	3-6 months

Trial Locations

Locations (1)

Women's Health Center; 🇪🇬 Assiut, Egypt