Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 2/27/2019 |
| Start Date: | September 22, 2017 |
| End Date: | December 2020 |
| Contact: | Vincenzo Berghella, MD |
| Email: | vincenzo.berghella@jefferson.edu |
| Phone: | 215-955-9200 |
Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length: a Randomized Clinical Trial
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
spontaneous preterm birth in singleton pregnancies with a short transvaginal cervical length
(<=25mm) and without prior spontaneous preterm birth
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
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
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
We found this trial at
2
sites
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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