Preterm BirthNCT05334264
Prophylactic Cervical Cerclage in Twin Pregnancies With Non-shortened Cervix
A study testing Cervical cerclage in people with Preterm Birth and Twin Pregnancy, Antepartum Condition or Complication, run by Zagazig University at 1 site in Egypt.
Trial summary
This randomized controlled trial is aimed to assess the protective value of prophylactic cervical cerclage against preterm birth in twin pregnancies with history of one or more preterm births without having cervical shortening in the current pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Twin Pregnancy, Antepartum Condition or Complication, Cervical Cerclage
- 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
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2021to 15 Oct 2023
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-50 years.
- Dichorionic twins.
- History of ≥1 preterm birth.
- Transvaginal sonographic cervical length is ≥25 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, 1 recruiting
- Recruiting
Faculty of medicine, Zagazig University
Zagazig, Sharqia Province, 44519
Hytham Atia, M.D., hythamatia@gmail.com
Amro El Nemr, M.D.
About this study
Official title: The Value of Prophylactic Cervical Cerclage Against Preterm Birth in Twin Pregnancies With History of Preterm Birth and Non-shortened Cervix: A Randomized Controlled Trial
This randomized controlled trial is aimed to assess the protective value of prophylactic cervical cerclage against preterm birth in twin pregnancies with history of one or more preterm births without having cervical shortening in the current pregnancy.
Read the detailed description
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 deaths.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 births5, Fuchs and Senat6 concluded that cervical cerclage in asymptomatic twins did not reduce the risk of PTB. This conclusion came depending on small sample sized randomized trail done on less than 50 patients.7 Available meta-analytic data remained of limited value in view of the few and small clinical studies that were included.
Although the current meta-analyses indicate the lack of efficacy of cerclage in twin pregnancies, data from the US Standard Certificate of Live Birth indicated that roughly 10% of triplets and 1.3% of twins are still receiving cerclage.8 Some authors compared the efficacy of cerclage in twin pregnancies and singleton pregnancies and showed that women with twin pregnancies who received cerclage might show beneficial obstetric outcomes similar to those of women with singleton gestations.9,10 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.
- 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 |
|---|---|---|
| Group A | Experimental | cervical cerclage between 14 and 20 weeks will be done by one of the three authors. McDonald cervical cerclage. Receives: Procedure: Cervical cerclage |
| Group B | No intervention | Routine antenatal care 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 ≤35+6, ≤33+6, and ≤31+6 weeks.
Number of preterm deliveries stratified according to gestational age groups mentioned
Measured: immediately after delivery for study cases through study completion, an average of 1 year
Secondary outcomes (3)
The incidence of miscarriage.
Number of missed, inevitable and complete miscarriage less than 20 weeks
Measured: immediately after occurrence of miscarriage through study completion, an average of 1 year
Incidence of cervico-vaginal infection
Number of infections diagnosed by patient complaint, clinical examination and confirmed by culture and sensitivity
Measured: once reported or confirmed during pregnancy through study completion, an average of 1 year
Incidences of bad Neonatal outcomes in both groups
Number of of neonates with respiratory distress, IVH, necrotizing enterocolitis, sepsis, NICU admission
Measured: during early neonatal follow up 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 posted19 Apr 2022
- Study start20 Dec 2021
- Primary completion28 Sep 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hytham Atia, Zagazig University
- Investigators
- Amro El Nemr, Principal investigator, Zagazig UniversityMohamed Lashin, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334264
- Sponsor's protocol ID
- ZU-IRB #8084/17-10-2021
- Status last verified
- Jul 2023
- First submitted
- 11 Dec 2021
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Prophylactic Cervical Cerclage Against Preterm Birth in Twin Pregnancies With History of Preterm Birth and Non-shortened Cervix: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05334264
- Acronym / sponsor ID
- ZU-IRB #8084/17-10-2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 28 Sep 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 19 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 assess the protective value of prophylactic cervical cerclage against preterm birth in twin pregnancies with history of one or more preterm births without having cervical shortening in the current pregnancy.
Detailed description
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 deaths.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 births5, Fuchs and Senat6 concluded that cervical cerclage in asymptomatic twins did not reduce the risk of PTB. This conclusion came depending on small sample sized randomized trail done on less than 50 patients.7 Available meta-analytic data remained of limited value in view of the few and small clinical studies that were included.
Although the current meta-analyses indicate the lack of efficacy of cerclage in twin pregnancies, data from the US Standard Certificate of Live Birth indicated that roughly 10% of triplets and 1.3% of twins are still receiving cerclage.8 Some authors compared the efficacy of cerclage in twin pregnancies and singleton pregnancies and showed that women with twin pregnancies who received cerclage might show beneficial obstetric outcomes similar to those of women with singleton gestations.9,10 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Cervical cerclagecervical cerclage between 14 and 20 weeks will be done by one of the three authors. McDonald cervical cerclage. |
| Group B | No intervention | –Routine antenatal care without cerclage |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18-50 years.
- Dichorionic twins.
- History of ≥1 preterm birth.
- Transvaginal sonographic cervical length is ≥25 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 | Group A |
Primary outcome
The incidence of preterm birth at ≤35+6, ≤33+6, and ≤31+6 weeks.
Time frame: immediately after delivery for study cases through study completion, an average of 1 year
Number of preterm deliveries stratified according to gestational age groups mentioned
3 secondary outcomes
The incidence of miscarriage.
Time frame: immediately after occurrence of miscarriage through study completion, an average of 1 year
Incidence of cervico-vaginal infection
Time frame: once reported or confirmed during pregnancy through study completion, an average of 1 year
Incidences of bad Neonatal outcomes in both groups
Time frame: during early neonatal follow up through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- 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.
Amro El Nemr principal investigator
Zagazig University
Mohamed Lashin 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, Antepartum Condition or Complication, 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 5 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hytham Atia (+966538308500, hythamatia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of preterm birth at ≤35+6, ≤33+6, and ≤31+6 weeks. (time frame: immediately after delivery for study cases 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 12 Jul 2023.