Preterm BirthNCT05338164
Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix
A study testing cervical cerclage in people with Preterm Birth and Twin Pregnancy With Antenatal Problem, run by Zagazig University at 1 site in Egypt.
Trial summary
This randomized controlled trial is aimed to evaluate pregnancy and neonatal outcomes in twin pregnancies, in which a cervical cerclage is placed due to the shortening of the cervix with or without visible fetal membranes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Twin Pregnancy With Antenatal Problem, Cervical Shortening
- What is being tested?
- cervical cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2021to 31 Oct 2024
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-45 years.
- Dichorionic twins.
- Transvaginal sonographic cervical length is <25 mm with or without internal os dilatation ≥10 mm at 14-20 weeks gestational age.
- Asymptomatic.
Who cannot join
- Triplets and quadruplets.
- Monochorionic twins.
- Threatened/ inevitable miscarriage
- Bulging membranes through the external os.
- Extremes of age.
- Major fetal anomalies.
Show all 9Show fewer
- Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis… etc.
- Fetal demise.
- Fetal reduction in the current pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine, Zagazig University
Zagazig, Sharqia Province, 44519
About this study
Official title: Protective Value of Cervical Cerclage Against Preterm Birth in Twin Pregnancy With Short Cervix. A Randomized Controlled Trial.
This randomized controlled trial is aimed to evaluate pregnancy and neonatal outcomes in twin pregnancies, in which a cervical cerclage is placed due to the shortening of the cervix with or without visible fetal membranes.
Read the detailed description
Introduction Multiple pregnancies are high-risk pregnancies and usually associated with an increased risk of neonatal morbidity and mortality, mainly due to preterm births. Preterm births occur in 50% of twin pregnancies and the mean gestational age for delivery is 35.3 weeks. Ten percent of all twin births take place before 32 weeks of gestation.1 Preterm births are responsible for more than 70% of all neonatal and infant mortality.2 Prematurity can have serious consequences for the child, such as hearing difficulties, vision impairment, learning disabilities, reduced IQ, and cerebral palsy. A cervical length of ≤25 mm in twin pregnancies is a good predictor of a spontaneous preterm birth when measured around 24 weeks of gestation.3,4 Numerous interventions have been attempted in order to prevent preterm births in twin gestations, but until now, no intervention has been effective. Use of cerclage in twin pregnancies is controversial. Some experts claim that placing a cervical cerclage could increase the risk of preterm births.5 However, there is growing evidence of beneficial effect of applying cervical cerclage. Based on a few, small, controlled trials, cervical cerclage may extend the pregnancy, if it is applied to a cervix of less than 15 mm.6,7 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.
Rationale:
Pregnant in twins with history suggesting cervical weakness and evidence of shortened cervix in the current pregnancy might get benefit from mechanical support by cervical cerclage in trial to reduce the risk of preterm birth.
- Being tested
- cervical cerclage
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical cerclageProcedure or surgery
McDonald cervical cerclage will be applied using Mersaline braided tape with double needle. Single stitch (4 bites) will be applied as close as possible to the level of internal os. The Knot will be put either anterior or posterior according to the surgeon desire.
| Study group | Role | What they receive |
|---|---|---|
| Cerclage group | Experimental | cervical cerclage between 14 and 20 weeks will be done by one of the three authors. Receives: Procedure: cervical cerclage |
| No Cerclage group | No intervention | Routine follow up without cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤25 mm
Rate of preterm births stratified by gestational age inside the included women
Measured: Immediate reporting of cases at time of delivery through study completion, an average of 1 year
Secondary outcomes (4)
Subgroup analysis for the risk of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤15 mm
subgroup analysis for rate of preterm births for very short cervix
Measured: Immediate reporting of cases at time of delivery through study completion, an average of 1 year
The incidence of miscarriage.
rate of missed, inevitable and complete miscarriages
Measured: Immediate reporting of cases at time of miscarriage through study completion, an average of 1 year
Incidence of cervico-vaginal infection
Rate of infections diagnosed during pregnancy by patient complaint, clinical examination and confirmed by culture and sensitivity).
Measured: after confirmation of infection through study completion, an average of 1 year
Neonatal outcomes in both groups
Rate of untoward early neonatal outcomes respiratory distress, IVH, necrotizing enterocolitis, sepsis, NICU admission
Measured: early neonatal through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start20 Dec 2021
- Primary completion27 Aug 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hytham Atia, Zagazig University
- Investigators
- Mohamed Lashiin, M.D., Principal investigator, Zagazig UniversityAmro El Nemr, M.D., Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338164
- Sponsor's protocol ID
- ZU-IRB #8090/17-10-2021
- Status last verified
- Feb 2025
- First submitted
- 11 Dec 2021
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Value of Cervical Cerclage Against Preterm Birth in Twin Pregnancy With Short Cervix. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05338164
- Acronym / sponsor ID
- ZU-IRB #8090/17-10-2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 21 Apr 2022 (actual)
- 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.
This randomized controlled trial is aimed to evaluate pregnancy and neonatal outcomes in twin pregnancies, in which a cervical cerclage is placed due to the shortening of the cervix with or without visible fetal membranes.
Detailed description
Introduction Multiple pregnancies are high-risk pregnancies and usually associated with an increased risk of neonatal morbidity and mortality, mainly due to preterm births. Preterm births occur in 50% of twin pregnancies and the mean gestational age for delivery is 35.3 weeks. Ten percent of all twin births take place before 32 weeks of gestation.1 Preterm births are responsible for more than 70% of all neonatal and infant mortality.2 Prematurity can have serious consequences for the child, such as hearing difficulties, vision impairment, learning disabilities, reduced IQ, and cerebral palsy. A cervical length of ≤25 mm in twin pregnancies is a good predictor of a spontaneous preterm birth when measured around 24 weeks of gestation.3,4 Numerous interventions have been attempted in order to prevent preterm births in twin gestations, but until now, no intervention has been effective. Use of cerclage in twin pregnancies is controversial. Some experts claim that placing a cervical cerclage could increase the risk of preterm births.5 However, there is growing evidence of beneficial effect of applying cervical cerclage. Based on a few, small, controlled trials, cervical cerclage may extend the pregnancy, if it is applied to a cervix of less than 15 mm.6,7 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.
Rationale:
Pregnant in twins with history suggesting cervical weakness and evidence of shortened cervix in the current pregnancy might get benefit from mechanical support by cervical cerclage in trial to reduce the risk of preterm birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerclage group | Experimental | Procedure: cervical cerclagecervical cerclage between 14 and 20 weeks will be done by one of the three authors. |
| No Cerclage group | No intervention | –Routine follow up without cerclage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18-45 years.
- Dichorionic twins.
- Transvaginal sonographic cervical length is <25 mm with or without internal os dilatation ≥10 mm at 14-20 weeks gestational age.
- Asymptomatic.
Key exclusion criteria (9 listed)
- Triplets and quadruplets.
- Monochorionic twins.
- Threatened/ inevitable miscarriage
- Bulging membranes through the external os.
- Extremes of age.
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 |
|---|---|---|
| cervical cerclageMcDonald cervical cerclage will be applied using Mersaline braided tape with double needle. Single stitch (4 bites) will be applied as close as possible to the level of internal os. The Knot will be put either anterior or posterior according to the surgeon desire. | Procedure or surgery | Cerclage group |
Primary outcome
The incidence of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤25 mm
Time frame: Immediate reporting of cases at time of delivery through study completion, an average of 1 year
Rate of preterm births stratified by gestational age inside the included women
4 secondary outcomes
Subgroup analysis for the risk of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤15 mm
Time frame: Immediate reporting of cases at time of delivery through study completion, an average of 1 year
The incidence of miscarriage.
Time frame: Immediate reporting of cases at time of miscarriage through study completion, an average of 1 year
Incidence of cervico-vaginal infection
Time frame: after confirmation of infection through study completion, an average of 1 year
Neonatal outcomes in both groups
Time frame: early neonatal through study completion, an average of 1 year
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Mohamed Lashiin, M.D. principal investigator
Zagazig University
Amro El Nemr, M.D. principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical cerclage in people with Preterm Birth and Twin Pregnancy With Antenatal Problem, run by Zagazig 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 4 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 27 Feb 2025. 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. 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?
The incidence of preterm birth at ≤33+6, and ≤31+6 weeks with cervical length ≤25 mm (time frame: Immediate reporting of cases at time of delivery through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2025.