N-Acetyl Cysteine After Cervical Cerclage | NCT00787813

Studies
N-Acetyl Cysteine After Cervical Cerclage

NCT00787813

Sponsor

Assiut University

Status

Completed

Last Update Posted

Nov 20, 2008Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Cervical Cerclage

Interventions

N-Acetyl Cysteine
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Nov 7, 2008

First Submission Date that Met QC Criteria

Nov 7, 2008

First Posted Date

Nov 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2008

Last Update Posted Date

Nov 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	N-Acetyl Cysteine	Drug: N-Acetyl Cysteine
2	Placebo Comparator	placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-Acetyl Cysteine	Drug	oral daily dose of 0.6 g of N-acetyl cysteine in effervescent form	1

Measure	Description	Time Frame
Gestational age at delivery		3-6 months

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AHMED M NASR, MD	Women's Health Center, Assiut University, EGYPT	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's Health Center		Asyut	Asyut Governorate	71516	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18851855	Background	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.
32970845	Derived	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.

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals