LATCH: LATe Cerclage in High-risk Pregnancies
Study Details
Study Description
Brief 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 cervical length (≤25mm) between 24 0/7-26 6/7 weeks.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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N/A |
Detailed Description
Singleton high-risk pregnancies < 24 weeks of gestation will be screened for enrollment and randomized, if a short transvaginal cervical length (≤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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cerclage Cervical cerclage placement with removal during the 36th week of gestation or earlier if clinically indicated. |
Procedure: Cervical cerclage
Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.
Other Names:
Drug: Vaginal Suppository Progesterone
Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
Other Names:
|
Other: Control Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation. |
Drug: Vaginal Suppository Progesterone
Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of preterm birth <37 weeks [At delivery]
Secondary Outcome Measures
- 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 [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 [At the time of delivery at any gestational age]
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 [WBC > 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.
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-50 years old, pregnant, assigned female at birth
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Singleton pregnancy
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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
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Preterm labor, defined as painful regular uterine contractions and change in cervical dilation
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Preterm prelabor rupture of membranes (PPROM)
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Active vaginal bleeding
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Suspected intraamniotic infection
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Major fetal structural abnormality or chromosomal disorder
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Placenta previa or accreta
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Other contraindication to cerclage placement
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Participation in another clinical trial related to PTB prevention, cerclage, or progesterone
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Thomas Jefferson University
Investigators
- Principal Investigator: Moti Gulersen, MD, MSc, Thomas Jefferson University
Study Documents (Full-Text)
None provided.More Information
Publications
- iRISID-2023-2321