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Completed

NCT Number: NCT00787813

N-Acetyl Cysteine After Cervical Cerclage

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.

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Key information

Conditions

Cervical Cerclage

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Health Center

Asyut, Asyut Governorate, 71516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetyl cysteine

Drug

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

Other names: placebo

Placebo

Drug

Primary outcomes

  1. Gestational age at delivery

    Time frame: 3-6 months

Secondary outcomes

  1. Take home babies, neonatal morbidity

    Time frame: 3-6 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: NAC-CC

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 10, 2008
Registry last updated
Nov 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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