Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix (COLORS)

Thomas Jefferson University

Status and phase: Completed; Phase 4

Conditions: Premature Birth

Treatments: Drug: Vaginal progesterone; Procedure: Cervical cerclage

Study type: Interventional

Funder types: Other

Identifiers

NCT03251729

17D.164

Details and patient eligibility

About

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

Full 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

Enrollment: 93 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Cerclage

Experimental group

Description:

Cervical cerclage placement along with vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.

Treatment:

Procedure: Cervical cerclage

Drug: Vaginal progesterone

Control

Other group

Description:

Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks.

Treatment:

Drug: Vaginal progesterone