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

Assiut University

Status

Completed

Conditions

Cervical Cerclage

Treatments

Drug: N-Acetyl Cysteine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00787813

NAC after cerclage

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.