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N-Acetyl Cysteine After Cervical Cerclage

NCT ID: NCT00787813

Last Updated: 2008-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Cervical Cerclage

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

N-Acetyl Cysteine

Group Type ACTIVE_COMPARATOR

N-Acetyl Cysteine

Intervention Type DRUG

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

2

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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N-Acetyl Cysteine

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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placebo

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Department of Obstetrics & Gynecology

Principal Investigators

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AHMED M NASR, MD

Role: PRINCIPAL_INVESTIGATOR

Women's Health Center, Assiut University, EGYPT

Locations

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Women's Health Center

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 18851855 (View on PubMed)

Eleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.

Reference Type DERIVED
PMID: 32970845 (View on PubMed)

Other Identifiers

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NAC after cerclage

Identifier Type: -

Identifier Source: org_study_id