Cervical Cerclage Clinical Trial
— NAC-CCOfficial title:
Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial
Verified date | November 2008 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Health and Population |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Egypt | Women's Health Center | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gestational age at delivery | 3-6 months | No | |
Secondary | Take home babies, neonatal morbidity | 3-6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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