Short Cervix, TwinsNCT02912390
Cerclage for Short Cervix in Twins
A study testing Cerclage and Expectant management in people with Short Cervix, Twins, run by St. Louis University at 1 site in United States.
Trial summary
Through cervical length measurement in uncomplicated twin gestations, women with cervical length ≤ 25 mm will be approached for randomization to cerclage placement or expectant management with activity restriction and treatment of preterm labor Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Short Cervix, Twins
- What is being tested?
- Cerclage and Expectant management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2017to 11 Apr 2018
- 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 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- at least 14 years of age, but less than 55 yrs of age
- must be able to read and write English
- must be able to give informed consent.
- Twin pregnancy
Who cannot join
- Women with a serious physical or mental illness or condition that would substantially interfere with participation in the study
- membrane prolapse beyond the external cervical os,
- major fetal anomaly in either twins will be excluded from randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerclage for Ultrasound-Diagnosed Short Cervix in Twins: A Randomized Controlled Trial
Through cervical length measurement in uncomplicated twin gestations, women with cervical length ≤ 25 mm will be approached for randomization to cerclage placement or expectant management with activity restriction and treatment of preterm labor
Read the detailed description
Pregnant women with twin gestations are screened for short cervix with transvaginal cervical length measurements as part of routine care at St. Mary's Health Center (SMHC) and Saint Louis University's (SLUCare) Physician Group. (Transvaginal cervical length measurement every 2 weeks from 16weeks/0days-23weeks/6days weeks, per hospital practice) Women pregnant with twin gestations at SMHC who meet study criteria will undergo transvaginal length screening between 16 and 24 weeks gestation. Those women with transvaginal cervical length measurements at or below 25 mm will be approached for study participation.
If a patient agrees to participate in the trial, they will be randomized in 1:1 fashion to cerclage vs. expectant management.
Participants found to have a vaginal infection by cultures performed at randomization will be treated with appropriate antibiotics per usual institutional practices
Cerclage arm:
- Macdonald cerclage placed in standard fashion: mersilene suture preferred for standardization
Expectant management arm:
- Patient is placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest.
If a participant does not consent to participate in the trial, permission to collect their outcome information in an observational manner will be requested.
The neonatal medical record will be reviewed for outcome data on twins, weights, complications, neonatal intensive care unit (NICU) stay, to 28 day after discharge.
- Conditions
- Short Cervix, Twins
- Being tested
- Cerclage, Expectant management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerclageProcedure or surgery
Macdonald cerclage placed in standard fashion
Expectant managementOther
placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest.
| Study group | Role | What they receive |
|---|---|---|
| Cerclage | Active comparator | - Macdonald cerclage placed in standard fashion Receives: Procedure: Cerclage |
| Expectant management | Active comparator | - Patient is placed on activity restrictions Receives: Other: Expectant management |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical length ≤ 25 mm.
To determine whether cerclage placement in women with twin gestation and cervical length ≤ 25 mm results in pregnancy prolongation.
Measured: 1 year
Secondary outcomes (1)
cervical length ≤ 15 mm.
To perform a planned subgroup analysis with adequate power to determine whether cerclage placement results in pregnancy prolongation in twins gestations with cervical length ≤ 15 mm.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start12 Jan 2017
- Primary completionMar 2018
- Study completion11 Apr 2018
Why it stopped: On Internal Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Cervix, TwinsStudies 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
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Vricella, MD, St. Louis University
- Investigators
- Laura Vricella, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912390
- Sponsor's protocol ID
- 27073a
- Other IDs
- Cerclage in Twins
- Status last verified
- Apr 2018
- First submitted
- 2 Aug 2016
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerclage for Ultrasound-Diagnosed Short Cervix in Twins: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02912390
- Acronym / sponsor ID
- 27073a
- Conditions
- Short Cervix, Twins
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: On Internal Hold
- Enrolment
- 9 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 12 Jan 2017
- Primary completion
- Mar 2018 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 23 Sep 2016 (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.
Through cervical length measurement in uncomplicated twin gestations, women with cervical length ≤ 25 mm will be approached for randomization to cerclage placement or expectant management with activity restriction and treatment of preterm labor
Detailed description
Pregnant women with twin gestations are screened for short cervix with transvaginal cervical length measurements as part of routine care at St. Mary's Health Center (SMHC) and Saint Louis University's (SLUCare) Physician Group. (Transvaginal cervical length measurement every 2 weeks from 16weeks/0days-23weeks/6days weeks, per hospital practice) Women pregnant with twin gestations at SMHC who meet study criteria will undergo transvaginal length screening between 16 and 24 weeks gestation. Those women with transvaginal cervical length measurements at or below 25 mm will be approached for study participation.
If a patient agrees to participate in the trial, they will be randomized in 1:1 fashion to cerclage vs. expectant management.
Participants found to have a vaginal infection by cultures performed at randomization will be treated with appropriate antibiotics per usual institutional practices
Cerclage arm:
- Macdonald cerclage placed in standard fashion: mersilene suture preferred for standardization
Expectant management arm:
- Patient is placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest.
If a participant does not consent to participate in the trial, permission to collect their outcome information in an observational manner will be requested.
The neonatal medical record will be reviewed for outcome data on twins, weights, complications, neonatal intensive care unit (NICU) stay, to 28 day after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerclage | Active comparator | Procedure: Cerclage- Macdonald cerclage placed in standard fashion |
| Expectant management | Active comparator | Other: Expectant management- Patient is placed on activity restrictions |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- at least 14 years of age, but less than 55 yrs of age
- must be able to read and write English
- must be able to give informed consent.
- Twin pregnancy
Key exclusion criteria (3 listed)
- Women with a serious physical or mental illness or condition that would substantially interfere with participation in the study
- membrane prolapse beyond the external cervical os,
- major fetal anomaly in either twins will be excluded from randomization.
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 |
|---|---|---|
| CerclageMacdonald cerclage placed in standard fashion | Procedure or surgery | Cerclage |
| Expectant managementplaced on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest. | Other | Expectant management |
Primary outcome
cervical length ≤ 25 mm.
Time frame: 1 year
To determine whether cerclage placement in women with twin gestation and cervical length ≤ 25 mm results in pregnancy prolongation.
1 secondary outcome
cervical length ≤ 15 mm.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: On Internal Hold). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Short Cervix, Twins
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.
Laura Vricella, MD principal investigator
St. Louis 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 Cerclage and Expectant management in people with Short Cervix, Twins, run by St. Louis University at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 13 Apr 2018. 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 United States. 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 was stopped early (reason given: On Internal Hold). Results are not available in the source record.
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?
cervical length ≤ 25 mm. (time frame: 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 13 Apr 2018.