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RCT assessing preterm delivery rate in singleton pregnancies having a physical-exam indicated cerclage placed between 24 weeks and 25 weeks and 6 days. Patients randomized to either cerclage intervention or routine standard of care (no cerclage).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerclage | Experimental | Perform physical exam indicated cerclage between 24w0d to 25w6d |
|
| Control | No Intervention | No intervention; routine monitoring in pregnancy for preterm delivery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Exam Indicated Cerclage | Procedure | Transvaginal cervical cerclage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preterm Delivery Rate | Compare preterm delivery rate between women receiving cerclage intervention between 24w0d and 25w6d vs those not receiving cerclage during this gestational age period | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Outcomes | Rate of neonatal outcomes compared between the two groups ( NICU length of stay, neonatal death, neonatal disease (bronchopulmonary dysplasia, Necrotizing enterocolitis, Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy of prematurity, sepsis, death) | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Cerclage Surgical Complications | Rate of cerclage complications (intra-operative PPROM, hemorrhage, need for blood transfusion, cervical or vaginal laceration | 1 year |
Inclusion Criteria:
Exclusion Criteria:
Twin or higher order multi-fetal gestation
Multiparous patient, has had one or more preterm to term deliveries
Cervical dilation more than 2 cm either at the beginning of the study or any time during the study
Amniotic membranes prolapsed beyond the external os
Fetal reduction procedure performed during current pregnancy
Ruptured membranes prior to randomization
Major fetal structural anomaly
Fetal chromosomal abnormality, suspected or confirmed with additional genetic testing
Cerclage already in place for other indication
Active vaginal bleeding
Suspicion of chorioamnionitis
Placenta previa
Painful regular uterine contractions
History of preterm birth before 37 weeks gestation
Non-English or non-Spanish speaking
a. Given that the study is explained in person and consent forms are written in English, there is no guarantee that the study will be explained correctly when using a phone translator. The same is true if the current English consent form were to be translated into a language other than English. There is no way to confirm that the integrity of the study is being upheld by using translating services. If the integrity of the study is not upheld, then this poses harm to the patient.
Women under 18 years of age
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Craig Zelig, MD | Contact | 9105464305 | zeligc@amc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center | Recruiting | Albany | New York | 12208 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Intervention (cerclage) and control (no-cerclage) to reduce/prevent preterm delivery in those with a dilated cervix between 24w0d and 25w6d
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| D000091642 | Urogenital Diseases |