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Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

Primary Purpose

Preterm Birth

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Cervical cerclage

About this trial

This is an interventional treatment trial for Preterm Birth

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Gabriele SacconeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cervical cerclage

No intervention

Arm Description

Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix

No cerclage Women randomized to not receive cerclage represent the control arm

Outcomes

Primary Outcome Measures

Spontaneous preterm birth rates <34weeks

Secondary Outcome Measures

Spontaneous preterm birth rates <37, <28 and <24 weeks

Type of delivery

Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery

Spontaneous rupture of membranes

Ruptured membranes <34 weeks

Neonatal death

birth weight

Chorioamnionitis

histologic diagnosis of chorioamnionitis

necrotizing enterocolitis

intraventricular hemorrhage

intraventricular hemorrhage (grade 3 or higher)

respiratory distress syndrome

bronchopulmonary dysplasia

blood-culture proven sepsis

neonatal mortality

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

perinatal death

either fetal mortality or neonatal mortality

Full Information

NCT ID

NCT02716922

First Posted

March 6, 2016

Last Updated

March 17, 2016

Sponsor

Federico II University

1. Study Identification

Unique Protocol Identification Number

NCT02716922

Brief Title

Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

Official Title

Cervical Cerclage for Singleton Gestations With Short Cervix and Without Prior Preterm Birth

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federico II University

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Birth

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cervical cerclage

Arm Type

Experimental

Arm Description

Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix

Arm Title

No intervention

Arm Type

No Intervention

Arm Description

No cerclage Women randomized to not receive cerclage represent the control arm

Intervention Type

Procedure

Intervention Name(s)

Cervical cerclage

Intervention Description

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)

Primary Outcome Measure Information:

Title

Spontaneous preterm birth rates <34weeks

Time Frame

Less than 34 weeks gestation

Secondary Outcome Measure Information:

Title

Spontaneous preterm birth rates <37, <28 and <24 weeks

Time Frame

Less than 24, 28, and 37 weeks gestation

Title

Type of delivery

Description

Cesarean delivery, Spontaneous vaginal delivery, operative vaginal delivery

Time Frame

Time of delivery

Title

Spontaneous rupture of membranes

Description

Ruptured membranes <34 weeks

Time Frame

Less than 34 weeks gestation

Title

Neonatal death

Time Frame

Between birth and 28 days of age

Title

birth weight

Time Frame

Time of delivery

Title

Chorioamnionitis

Description

histologic diagnosis of chorioamnionitis

Time Frame

Time of delivery

Title

necrotizing enterocolitis

Time Frame

Between birth and 28 days of age

Title

intraventricular hemorrhage

Description

intraventricular hemorrhage (grade 3 or higher)

Time Frame

Between birth and 28 days of age

Title

respiratory distress syndrome

Time Frame

Between birth and 28 days of age

Title

bronchopulmonary dysplasia

Time Frame

Between birth and 28 days of age

Title

blood-culture proven sepsis

Time Frame

Between birth and 28 days of age

Title

neonatal mortality

Description

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

Time Frame

Between birth and 28 days of age

Title

perinatal death

Description

either fetal mortality or neonatal mortality

Time Frame

Until 28 days of age

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Gabriele Saccone

City

Napoli

ZIP/Postal Code

80129

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabriele Saccone

Phone

3394685179

gabriele.saccone@libero.it

12. IPD Sharing Statement

Plan to Share IPD

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Cerclage for Singletons With Short Cervix Without Prior Preterm Birth

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