Preterm Birth
Conditions
Brief summary
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).
Interventions
PROCEDUREPhysical Exam Indicated Cerclage
Transvaginal cervical cerclage
Sponsors
Albany Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Intervention (cerclage) and control (no-cerclage) to reduce/prevent preterm delivery in those with a dilated cervix between 24w0d and 25w6d
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant women 18 years of age or older 2. Nulliparous patient, has not had a preterm to term delivery 3. Singleton pregnancy 4. English or Spanish speaking 5. Asymptomatic cervical dilation between 1- 2 cm, without visible membranes beyond the external cervical os and without any evidence of infection, active labor or active bleeding between 24 0/7 and 25 6/7 weeks gestation
Exclusion criteria
1. Twin or higher order multi-fetal gestation 2. Multiparous patient, has had one or more preterm to term deliveries 3. Cervical dilation more than 2 cm either at the beginning of the study or any time during the study 4. Amniotic membranes prolapsed beyond the external os 5. Fetal reduction procedure performed during current pregnancy 6. Ruptured membranes prior to randomization 7. Major fetal structural anomaly 8. Fetal chromosomal abnormality, suspected or confirmed with additional genetic testing 9. Cerclage already in place for other indication 10. Active vaginal bleeding 11. Suspicion of chorioamnionitis 12. Placenta previa 13. Painful regular uterine contractions 14. History of preterm birth before 37 weeks gestation 15. 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. 16. Women under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm Delivery Rate | 1 Year | Compare preterm delivery rate between women receiving cerclage intervention between 24w0d and 25w6d vs those not receiving cerclage during this gestational age period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Outcomes | 1 Year | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cerclage Surgical Complications | 1 year | Rate of cerclage complications (intra-operative PPROM, hemorrhage, need for blood transfusion, cervical or vaginal laceration |
Countries
United States
Contacts
Primary ContactCraig Zelig, MD
Outcome results
None listed