N-Acetyl Cysteine After Cervical Cerclage
NAC-CC
Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 7, 2008
CompletedFirst Posted
Study publicly available on registry
November 10, 2008
CompletedNovember 20, 2008
November 1, 2008
4 months
November 7, 2008
November 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gestational age at delivery
3-6 months
Secondary Outcomes (1)
Take home babies, neonatal morbidity
3-6 months
Study Arms (2)
1
ACTIVE COMPARATORN-Acetyl Cysteine
2
PLACEBO COMPARATORplacebo
Interventions
oral daily dose of 0.6 g of N-acetyl cysteine in effervescent form
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's Health Center
Asyut, Asyut Governorate, 71516, Egypt
Related Publications (2)
Shahin AY, Hassanin IM, Ismail AM, Kruessel JS, Hirchenhain J. Effect of oral N-acetyl cysteine on recurrent preterm labor following treatment for bacterial vaginosis. Int J Gynaecol Obstet. 2009 Jan;104(1):44-8. doi: 10.1016/j.ijgo.2008.08.026. Epub 2008 Oct 11.
PMID: 18851855BACKGROUNDEleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.
PMID: 32970845DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AHMED M NASR, MD
Women's Health Center, Assiut University, EGYPT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 7, 2008
First Posted
November 10, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2008
Study Completion
November 1, 2008
Last Updated
November 20, 2008
Record last verified: 2008-11