Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

• Sponsor: Federico II University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02716922
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2016
• Anticipated Primary Completion Date: Apr 1, 2018
• Anticipated Study Completion Date: Mar 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Spontaneous preterm birth rates <34weeks [Less than 34 weeks gestation]

Secondary Outcome Measures

1. Spontaneous preterm birth rates <37, <28 and <24 weeks [Less than 24, 28, and 37 weeks gestation]

2. Type of delivery [Time of delivery]

   Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery

3. Spontaneous rupture of membranes [Less than 34 weeks gestation]

   Ruptured membranes <34 weeks

4. Neonatal death [Between birth and 28 days of age]

5. birth weight [Time of delivery]

6. Chorioamnionitis [Time of delivery]

   histologic diagnosis of chorioamnionitis

7. necrotizing enterocolitis [Between birth and 28 days of age]

8. intraventricular hemorrhage [Between birth and 28 days of age]

   intraventricular hemorrhage (grade 3 or higher)

9. respiratory distress syndrome [Between birth and 28 days of age]

10. bronchopulmonary dysplasia [Between birth and 28 days of age]

11. blood-culture proven sepsis [Between birth and 28 days of age]

12. neonatal mortality [Between birth and 28 days of age]

    death of a live-born baby within the first 28 days of life

13. perinatal death [Until 28 days of age]

    either fetal mortality or neonatal mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gabriele Saccone	Napoli		Italy	80129

Sponsors and Collaborators

• Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gabriele Saccone, Medical Doctor, Federico II University
• ClinicalTrials.gov Identifier: NCT02716922
• Other Study ID Numbers: 33/2016
• First Posted: Mar 23, 2016
• Last Update Posted: Mar 23, 2016
• Last Verified: Mar 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Mar 23, 2016