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Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

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ClinicalTrials.gov Identifier: NCT02716922
Recruitment Status : Unknown
Verified March 2016 by Gabriele Saccone, Federico II University.
Recruitment status was:  Recruiting
First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Gabriele Saccone, Federico II University

Brief Summary:
Preterm birth remains the most common cause of perinatal morbidity and mortality. A short cervi- cal length on transvaginal ultrasonography has been shown to be one of the best predictors of preterm birth. In 2005 a meta-analysis by Berghella et al. showed that cervical cerclage does not prevent preterm birth (PTB) in women with short cervical lenght without prior PTB. However maybe the meta-analysis did not reach the statistical significance due to the small sample size

Condition or disease Intervention/treatment Phase
Preterm Birth Procedure: Cervical cerclage Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth
Study Start Date : March 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: Cervical cerclage
Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix
Procedure: Cervical cerclage
Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)

No Intervention: No intervention
No cerclage Women randomized to not receive cerclage represent the control arm



Primary Outcome Measures :
  1. Spontaneous preterm birth rates <34weeks [ Time Frame: Less than 34 weeks gestation ]

Secondary Outcome Measures :
  1. Spontaneous preterm birth rates <37, <28 and <24 weeks [ Time Frame: Less than 24, 28, and 37 weeks gestation ]
  2. Type of delivery [ Time Frame: Time of delivery ]
    Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery

  3. Spontaneous rupture of membranes [ Time Frame: Less than 34 weeks gestation ]
    Ruptured membranes <34 weeks

  4. Neonatal death [ Time Frame: Between birth and 28 days of age ]
  5. birth weight [ Time Frame: Time of delivery ]
  6. Chorioamnionitis [ Time Frame: Time of delivery ]
    histologic diagnosis of chorioamnionitis

  7. necrotizing enterocolitis [ Time Frame: Between birth and 28 days of age ]
  8. intraventricular hemorrhage [ Time Frame: Between birth and 28 days of age ]
    intraventricular hemorrhage (grade 3 or higher)

  9. respiratory distress syndrome [ Time Frame: Between birth and 28 days of age ]
  10. bronchopulmonary dysplasia [ Time Frame: Between birth and 28 days of age ]
  11. blood-culture proven sepsis [ Time Frame: Between birth and 28 days of age ]
  12. neonatal mortality [ Time Frame: Between birth and 28 days of age ]
    death of a live-born baby within the first 28 days of life

  13. perinatal death [ Time Frame: Until 28 days of age ]
    either fetal mortality or neonatal mortality



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy (limits the participants to female gender)
  • Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
  • 18-50 years of age

Exclusion Criteria:

  • Multiple gestation
  • Prior spontaneous preterm birth 16-36 6/7 weeks
  • Ruptured membranes
  • Lethal fetal structural anomaly
  • Fetal chromosomal abnormality
  • Pessary in place (or planned placement)
  • Vaginal bleeding
  • Suspicion of chorioamnionitis
  • Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
  • Painful regular uterine contractions
  • Placenta previa

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716922


Locations
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Italy
Gabriele Saccone Recruiting
Napoli, Italy, 80129
Contact: Gabriele Saccone    3394685179    gabriele.saccone@libero.it   
Sponsors and Collaborators
Federico II University

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Responsible Party: Gabriele Saccone, Medical Doctor, Federico II University
ClinicalTrials.gov Identifier: NCT02716922     History of Changes
Other Study ID Numbers: 33/2016
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications