Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to determine whether cervical cerclage reduces the risk of preterm birth in patients with a short transvaginal ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks.
Singleton high-risk pregnancies < 24 weeks of gestation will be screened for enrollment and randomized, if a short TVU CL (≤25mm) is detected between 24 0/7 - 26 6/7 weeks, to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for continuing or initiating daily vaginal progesterone 200mg from randomization until 36 6/7 weeks. The primary outcome will be the incidence of preterm birth <37 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerclage | Experimental | Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated. |
|
| Control | Other | Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical cerclage | Procedure | Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of preterm birth <37 weeks | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks | At delivery | |
| Gestational age at delivery | At delivery | |
| Time interval from randomization to delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moti Gulersen, MD, MSc | Contact | 215-955-5000 | moti.gulersen@jefferson.edu | |
| Vincenzo Berghella, MD | Contact | 215-955-5000 | vincenzo.berghella@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Moti Gulersen, MD, MSc | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Carolinas Medical Center | Recruiting | Charlotte | North Carolina | 28204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36924844 | Background | Gulersen M, Lenchner E, Nicolaides KH, Otsuki K, Rust OA, Althuisius S, Bornstein E, Berghella V. Cervical cerclage for short cervix at 24 to 26 weeks of gestation: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Am J Obstet Gynecol MFM. 2023 Jun;5(6):100930. doi: 10.1016/j.ajogmf.2023.100930. Epub 2023 Mar 15. |
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D023802 | Cerclage, Cervical |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short TVU CL at 24-26 weeks of gestation.
Not provided
Not provided
Not provided
Not provided
| Vaginal Suppository Progesterone | Drug | Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation. |
|
|
| At delivery |
| Incidence of preterm prelabor rupture of membranes (PPROM) | At occurrence up to 36 weeks and 6 days of gestation |
| Incidence of intraamniotic infection | Defined by either presence of clinical criteria (i.e. includes maternal fever [temperature > 100.4 on two occasions at least 30 minutes apart] and one or more of the following: maternal leukocytosis [white blood cell count > 15,000], purulent cervical drainage, or fetal tachycardia), laboratory testing (positive amniotic fluid test result [gram stain, glucose level [<15], or culture results consistent with infection]), or placental pathology demonstrating histologic evidence of placental infection or inflammation. | At the time of delivery at any gestational age |
| Neonatal outcomes: incidence of low birthweight (<2500g) | At delivery |
| Neonatal outcomes: incidence of very low birthweight (<1500g) | At delivery |
| Neonatal outcomes: incidence of admission to neonatal intensive care unit | At delivery |
| Neonatal outcomes: composite outcome of incidence of either respiratory distress syndrome, bronchopulmonary dysplasia, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture confirmed sepsis, stillbirth, and neonatal mortality | At least 30 days after delivery, up to 6 months after delivery for outcomes except neonatal mortality |
| Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| D000091642 | Urogenital Diseases |