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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00787813
Other study ID # NAC after cerclage
Secondary ID
Status Completed
Phase N/A
First received November 7, 2008
Last updated November 19, 2008
Start date June 2008
Est. completion date November 2008

Study information

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

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
N-Acetyl Cysteine
oral daily dose of 0.6 g of N-acetyl cysteine in effervescent form
Placebo


Locations

Country Name City State
Egypt Women's Health Center Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT06399965 - Perioperative Use of Atosiban for Ultrasound-indicated Cerclage to Reduce Spontaneous Preterm Birth(sPTB) N/A
Recruiting NCT05334264 - Prophylactic Cervical Cerclage in Twin Pregnancies With Non-shortened Cervix N/A