Premature Birth
Conditions
Keywords
cerclage, preterm birth, short cervix
Brief summary
The aim of this study is to evaluate the efficacy of cervical cerclage in prevention of spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length (\<=25mm) and without prior spontaneous preterm birth
Detailed description
Singleton pregnancies between 18 0/7 to 23 6/7 weeks without a prior spontaneous preterm birth found to have a short transvaginal ultrasound cervical length (\<=25mm) and meeting all other eligibility criteria will be randomized to either cervical cerclage or control (no cerclage). Aside from cerclage placement, management of included women will be the same including recommendation for daily vaginal progesterone 200mg suppository or 90mg gel from randomization until 36 6/7 weeks. The primary outcome will be the incidence of spontaneous preterm birth \<35 weeks
Interventions
PROCEDURECervical cerclage
Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks
DRUGVaginal progesterone
Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks
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 pregnancies without prior spontaneous preterm birth and with a short transvaginal ultrasound cervical length
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 year old or older * Singleton pregnancy * No prior SPTB or second trimester losses between 160 and 366 weeks * TVU CL ≤25mm between 180 and 236 weeks
Exclusion criteria
* Multiple pregnancy * Prior SPTB or second trimester losses between 160 and 366 weeks * Cerclage in situ * Painful regular uterine contraction and/or preterm labor * Rupture membranes * Major fetal anomaly or aneuploidy * Active vaginal bleeding * Placenta previa and/or accreta * Cervical dilation \>1.0 cm and/or visible membranes by pelvic exam * Suspicion of chorioamnionitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm birth <35 weeks | At delivery | Incidence of spontaneous preterm birth less than 35 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Neonatal outcomes: low birth weight (<2500g), | At delivery |
| Neonatal outcomes: admission to intensive care nursery | At delivery |
| Neonatal outcomes: neonatal mortality | 28 days after delivery |
| Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks | At delivery |
| Mean gestational age at delivery | At delivery |
| Neonatal outcomes: birth weight | At delivery |
| Neonatal outcomes: length of neonatal hospital admission | at least 30 days after delivery, up to 6 months after delivery |
| Neonatal outcomes: respiratory distress syndrome | at least 30 days after delivery, up to 6 months after delivery |
| Neonatal outcomes: IVH grade 3 or 4 | at least 30 days after delivery, up to 6 months after delivery |
| Neonatal outcomes: retinopathy of prematurity | at least 30 days after delivery, up to 6 months after delivery |
| Neonatal outcomes: bronchopulmonary dysplasia | at least 30 days after delivery, up to 6 months after delivery |
| Histologically proven clinical chorioamnionitis | At delivery |
Countries
Italy, United States
Outcome results
None listed