Cervical cerclage
ProcedureTransvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks
NCT Number: NCT03251729
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
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Notify Me18 year–50 year
Female
Interventional
Phase 4
University of Naples Federico II, Naples, Italy
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks
Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks
Time frame: At delivery
Incidence of spontaneous preterm birth less than 35 weeks
Time frame: At delivery
Time frame: At delivery
Time frame: At delivery
Time frame: At delivery
Time frame: At delivery
Time frame: At delivery
Time frame: at least 30 days after delivery, up to 6 months after delivery
Time frame: at least 30 days after delivery, up to 6 months after delivery
Time frame: at least 30 days after delivery, up to 6 months after delivery
Time frame: at least 30 days after delivery, up to 6 months after delivery
Time frame: at least 30 days after delivery, up to 6 months after delivery
Time frame: 28 days after delivery
Thomas Jefferson University
Other
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
Acronym: COLORS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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