Premature Birth Clinical Trial
— LATCHOfficial title:
Cervical Cerclage for Short Cervix at 24-26 Weeks of Gestation: a Randomized Controlled Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
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
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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