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| ID | Type | Description | Link |
|---|---|---|---|
| Cerclage in Twins | Other Identifier | Saint Louis University Institutional Review Board |
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On Internal Hold
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerclage | Active Comparator | - Macdonald cerclage placed in standard fashion |
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| Expectant management | Active Comparator | - Patient is placed on activity restrictions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerclage | Procedure | Macdonald cerclage placed in standard fashion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| cervical length ≤ 25 mm. | To determine whether cerclage placement in women with twin gestation and cervical length ≤ 25 mm results in pregnancy prolongation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| cervical and vaginal microbiomes | To assess the cervical and vaginal microbiomes as well as presence of vaginal infections to determine potential predictors for spontaneous preterm birth in twin gestations with short cervix | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Vricella, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mary's Health Center | St Louis | Missouri | 63117 | United States |
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| ID | Term |
|---|---|
| D023802 | Cerclage, Cervical |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
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| Expectant management |
| Other |
placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest. |
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| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |