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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06036446
Other study ID # iRISID-2023-2321
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 10, 2023
Est. completion date February 2027

Study information

Verified date November 2023
Source Thomas Jefferson University
Contact Moti Gulersen, MD, MSc
Phone 215-955-5000
Email moti.gulersen@jefferson.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 329
Est. completion date February 2027
Est. primary completion date October 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 18-50 years old, pregnant, assigned female at birth - Singleton pregnancy - TVU CL =25mm between 24 0/7 - 26 6/7 weeks of gestation Exclusion Criteria: - Initial multifetal gestation with subsequent multifetal pregnancy reduction, or selective fetal termination performed >14 weeks, or cotwin pregnancy loss diagnosed >14 weeks - Cerclage in situ - Preterm labor, defined as painful regular uterine contractions and change in cervical dilation - PPROM - Active vaginal bleeding - Suspected intraamniotic infection - Major fetal structural abnormality or chromosomal disorder - Placenta previa or accreta - Other contraindication to cerclage placement - Participation in another clinical trial related to preterm birth prevention, cerclage, or progesterone

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cervical cerclage
Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.
Drug:
Vaginal Suppository Progesterone
Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.

Locations

Country Name City State
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of preterm birth <37 weeks At delivery
Secondary Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks At delivery
Secondary Gestational age at delivery At delivery
Secondary Time interval from randomization to delivery At delivery
Secondary Incidence of preterm prelabor rupture of membranes (PPROM) At occurrence up to 36 weeks and 6 days of gestation
Secondary 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
Secondary Neonatal outcomes: incidence of low birthweight (<2500g) At delivery
Secondary Neonatal outcomes: incidence of very low birthweight (<1500g) At delivery
Secondary Neonatal outcomes: incidence of admission to neonatal intensive care unit At delivery
Secondary 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
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