Twin; Pregnancy, Affecting Fetus or NewbornNCT03781466
Effect of Cervical Cerclage With Vaginal Progesterone in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix
A study testing Cervical cerclage and vaginal progesterone in people with Twin; Pregnancy, Affecting Fetus or Newborn, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Twin; Pregnancy, Affecting Fetus or Newborn
- What is being tested?
- Cervical cerclage and vaginal progesterone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2021
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women pregnant in dichorionic twins.
- Transvaginal sonographic cervical length is <25 mm at 16-20 weeks gestational age.
- No symptoms, signs or other risk factors for preterm labor
Who cannot join
- Age < 18 years or > 45 years.
- Known allergy or contraindication (relative or absolute) to progesterone therapy.
- Monochorionic twins.
- Known major fetal structural or chromosomal abnormality.
- Intrauterine death of one fetus or death of both fetuses.
- Fetal reduction in the current pregnancy.
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- Medical conditions that may lead to preterm delivery.
- Rupture of membranes.
- Vaginal bleeding
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, 81528
hany f sallam, md, 01092440504 ext. 002, nahla.elsayed@aswu.ed.eg
Nahla w Shady, md, 1019240504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Effect of Cervical Cerclage With or Without Vaginal Progesterone Versus Vaginal Progesterone Alone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix: A Randomized Clinical Trial
The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
Read the detailed description
There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
- Being tested
- Cervical cerclage, vaginal progesterone
- Keywords
- Preterm birth, Twin gestation, Vaginal progesterone, 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
Also called Active Comparator
Cervical cerclage indicated by short cervix ≤25mm
vaginal progesteroneDrug
Also called Active Comparator
Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cervical cerclage | Active comparator | Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm Receives: Procedure: Cervical cerclage |
| vaginal progesterone | Active comparator | Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks Receives: Drug: vaginal progesterone |
| Cervical cerclage plus vaginal progesterone | Active comparator | Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks Receives: Procedure: Cervical cerclage; Drug: vaginal progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm labor before 34 weeks
Number of patients with preterm birth before 34 weeks gestations
Measured: Up to 34 weeks gestational age
Secondary outcomes (2)
Neonatal respiratory distress syndrome
number of neonatal respiratory distress syndrome
Measured: At birth
Early neonatal death
number babies died in the neonatal period
Measured: within one month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin; Pregnancy, Affecting Fetus or NewbornStudies of the same condition, open and under way.
- 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
- Model description
- A randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781466
- Sponsor's protocol ID
- aswu/190/18
- Status last verified
- Feb 2019
- First submitted
- 18 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Cerclage With or Without Vaginal Progesterone Versus Vaginal Progesterone Alone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With a Sonographic Short Cervix: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03781466
- Acronym / sponsor ID
- aswu/190/18
- Keywords
- Preterm birth, Twin gestation, Vaginal progesterone, cervical cerclage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 20 Dec 2018 (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.
The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
Detailed description
There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Cervical cerclage | Active comparator | Procedure: Cervical cerclageCervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm |
| vaginal progesterone | Active comparator | Drug: vaginal progesteroneDaily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks |
| Cervical cerclage plus vaginal progesterone | Active comparator | Procedure: Cervical cerclage, Drug: vaginal progesteroneCervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women pregnant in dichorionic twins.
- Transvaginal sonographic cervical length is <25 mm at 16-20 weeks gestational age.
- No symptoms, signs or other risk factors for preterm labor
Key exclusion criteria (9 listed)
- Age < 18 years or > 45 years.
- Known allergy or contraindication (relative or absolute) to progesterone therapy.
- Monochorionic twins.
- Known major fetal structural or chromosomal abnormality.
- Intrauterine death of one fetus or death of both fetuses.
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 cerclageAlso: Active ComparatorCervical cerclage indicated by short cervix ≤25mm | Procedure or surgery | Cervical cerclage, Cervical cerclage plus vaginal progesterone |
| vaginal progesteroneAlso: Active ComparatorDaily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks | Drug | Cervical cerclage plus vaginal progesterone, vaginal progesterone |
Primary outcome
Preterm labor before 34 weeks
Time frame: Up to 34 weeks gestational age
Number of patients with preterm birth before 34 weeks gestations
2 secondary outcomes
Neonatal respiratory distress syndrome
Time frame: At birth
Early neonatal death
Time frame: within one month postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Twin; Pregnancy, Affecting Fetus or Newborn
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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.
hany f sallam, md principal investigator
Aswan University Hospital
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 and vaginal progesterone in people with Twin; Pregnancy, Affecting Fetus or Newborn, run by Aswan University Hospital 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 3 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 15 Feb 2019. 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 hany f sallam, md (01022336052 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm labor before 34 weeks (time frame: Up to 34 weeks gestational age). 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 15 Feb 2019.