Cervical CerclageNAC-CCNCT00787813
N-Acetyl Cysteine After Cervical Cerclage
A study testing N-Acetyl Cysteine in people with Cervical Cerclage, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cerclage
- What is being tested?
- N-Acetyl Cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2008to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cervical Cerclage
- Being tested
- N-Acetyl Cysteine, Placebo
- Keywords
- N-acetyl cysteine (NAC), Cervical cerclage, cervical cerclage for cervical insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl CysteineDrug
Also called placebo
oral daily dose of 0.6 g of N-acetyl cysteine in effervescent form
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | N-Acetyl Cysteine Receives: Drug: N-Acetyl Cysteine |
| 2 | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at delivery
Measured: 3-6 months
Secondary outcomes (1)
Take home babies, neonatal morbidity
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical CerclageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Investigators
- AHMED M NASR, MD, Principal investigator, Women's Health Center, Assiut University, EGYPT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787813
- Sponsor's protocol ID
- NAC after cerclage
- Acronym
- NAC-CC
- Status last verified
- Nov 2008
- First submitted
- 7 Nov 2008
- Last updated
- 20 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18851855Eleje 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.
PubMed 32970845
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral N-Acetyl Cysteine on Pregnancy Outcome After Cervical Cerclage: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00787813
- Acronym / sponsor ID
- NAC-CC / NAC after cerclage
- Conditions
- Cervical Cerclage
- Keywords
- N-acetyl cysteine (NAC), Cervical cerclage, cervical cerclage for cervical insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: N-Acetyl CysteineN-Acetyl Cysteine |
| 2 | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetyl CysteineAlso: placebooral daily dose of 0.6 g of N-acetyl cysteine in effervescent form | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Gestational age at delivery
Time frame: 3-6 months
1 secondary outcome
Take home babies, neonatal morbidity
Time frame: 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2008.
- Background: PubMed 18851855Shahin 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.
- Derived from this study: PubMed 32970845Eleje 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED M NASR, MD principal investigator
Women's Health Center, Assiut University, EGYPT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-Acetyl Cysteine in people with Cervical Cerclage, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at delivery (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00787813, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2008; AzTrials last refreshed its copy on 5 Nov 2026.