N-Acetyl Cysteine After Cervical Cerclage

Assiut University100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Cervical Cerclage

Interventions

N-Acetyl CysteineDRUG

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

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Women's Health Center

Asyut, Asyut Governorate, Egypt

Outcomes

Primary Outcomes

Gestational age at delivery

Time frame: 3-6 months

Secondary Outcomes

Take home babies, neonatal morbidity

Time frame: 3-6 months

Data from ClinicalTrials.gov

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