N-Acetyl Cysteine After Cervical Cerclage

Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00787813

Acronym

NAC-CC

Enrollment

100

Registered

2008-11-10

Start date

2008-06-30

Completion date

2008-11-30

Last updated

2008-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cerclage

Keywords

N-acetyl cysteine (NAC), Cervical cerclage, cervical cerclage for cervical insufficiency

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.

Interventions

DRUGN-Acetyl Cysteine

oral daily dose of 0.6 g of N-acetyl cysteine in effervescent form

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Gestational age at delivery	3-6 months

Secondary

Measure	Time frame
Take home babies, neonatal morbidity	3-6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026