Premature Birth
Conditions
Keywords
Cervical length, Short cervix, Shortened cervix, Prematurity, Preterm birth, Viability
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 ultrasound (TVU) cervical length (CL) ≤25mm between 24 0/7-26 6/7 weeks.
Detailed 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.
Interventions
PROCEDURECervical cerclage
Transvaginal cervical cerclage placed between 24 0/7 - 26 6/7 weeks of gestation.
DRUGVaginal Suppository Progesterone
Continuing or initiation of vaginal progesterone 200mg daily until 36 weeks of gestation.
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized trial of cerclage versus no cerclage in singleton high-risk pregnancies with a short TVU CL at 24-26 weeks of gestation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of preterm birth <37 weeks | At delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[white blood cell count \> 15,000\], 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. |
| Incidence of preterm birth <34 weeks, <32 weeks, and <28 weeks | 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 | — |
| Neonatal outcomes: incidence of low birthweight (<2500g) | At delivery | — |
Countries
United States
Contacts
Primary ContactMoti Gulersen, MD, MSc
Backup ContactVincenzo Berghella, MD
Outcome results
None listed