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Completed

NCT Number: NCT03251729

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

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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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Naples Federico II, Naples, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical cerclage

Procedure

Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks

vaginal progesterone

Drug

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

Primary outcomes

  1. Preterm birth <35 weeks

    Time frame: At delivery

    Incidence of spontaneous preterm birth less than 35 weeks

Secondary outcomes

  1. Preterm birth <37 weeks, <34 weeks, <32 weeks, <28 weeks, <24 weeks

    Time frame: At delivery

  2. Mean gestational age at delivery

    Time frame: At delivery

  3. Histologically proven clinical chorioamnionitis

    Time frame: At delivery

  4. Neonatal outcomes: birth weight

    Time frame: At delivery

  5. Neonatal outcomes: low birth weight (<2500g),

    Time frame: At delivery

  6. Neonatal outcomes: admission to intensive care nursery

    Time frame: At delivery

  7. Neonatal outcomes: length of neonatal hospital admission

    Time frame: at least 30 days after delivery, up to 6 months after delivery

  8. Neonatal outcomes: respiratory distress syndrome

    Time frame: at least 30 days after delivery, up to 6 months after delivery

  9. Neonatal outcomes: IVH grade 3 or 4

    Time frame: at least 30 days after delivery, up to 6 months after delivery

  10. Neonatal outcomes: retinopathy of prematurity

    Time frame: at least 30 days after delivery, up to 6 months after delivery

  11. Neonatal outcomes: bronchopulmonary dysplasia

    Time frame: at least 30 days after delivery, up to 6 months after delivery

  12. Neonatal outcomes: neonatal mortality

    Time frame: 28 days after delivery

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2017
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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