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Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?

Primary Purpose

Preterm Birth

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cervical pessary
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 18-50 years of age
  • Twin pregnancy (limits the participants to female gender)
  • Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation

Exclusion Criteria:

  • Singleton or higher order than twins multiple gestation
  • Monoamniotic twins
  • Twin twin transfusion syndrome
  • Ruptured membranes
  • Lethal fetal structural anomaly
  • Fetal chromosomal abnormality
  • Cerclage in place (or planned placement)
  • Vaginal bleeding
  • Suspicion of chorioamnionitis
  • Ballooning of membranes outside the cervix into the vagina
  • Painful regular uterine contractions
  • Labor
  • Placenta previa

Sites / Locations

  • Gabriele SacconeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cervical Pessary

No intervention

Arm Description

The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)

No pessary No pessary will be used. Subjects will receive standard obstetrical management

Outcomes

Primary Outcome Measures

Spontaneous Preterm delivery <34 weeks

Secondary Outcome Measures

Gestational age
Birth weight
Spontaneous preterm birth rates <37, <28 and <24 weeks
Spontaneous rupture of membranes
Rupture of membranes <34 weeks
Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)
cesarean delivery, operative vaginal delivery, spontaneous vaginal delivery
Neonatal death
Composite perinatal outcome
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death
Maternal side effects

Full Information

First Posted
March 6, 2016
Last Updated
November 15, 2018
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02708264
Brief Title
Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?
Official Title
Pessary in Prevention of Preterm Birth for Women With Twin Pregnancies and Short Cervical Length
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.

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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
outcomes assessor and data analyst
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cervical Pessary
Arm Type
Experimental
Arm Description
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No pessary No pessary will be used. Subjects will receive standard obstetrical management
Intervention Type
Device
Intervention Name(s)
Cervical pessary
Intervention Description
The cervical pessary is a silicone device that has been used to prevent SPTB
Primary Outcome Measure Information:
Title
Spontaneous Preterm delivery <34 weeks
Time Frame
Less than 34 weeks gestation
Secondary Outcome Measure Information:
Title
Gestational age
Time Frame
Time of delivery
Title
Birth weight
Time Frame
Time of delivery
Title
Spontaneous preterm birth rates <37, <28 and <24 weeks
Time Frame
Less than 24, 28, 34 and 37 weeks gestation
Title
Spontaneous rupture of membranes
Description
Rupture of membranes <34 weeks
Time Frame
Less than 34 weeks gestation
Title
Type of delivery (if cesarean or operativa vaginal or spontaneous vaginal delivery)
Description
cesarean delivery, operative vaginal delivery, spontaneous vaginal delivery
Time Frame
Time of delivery
Title
Neonatal death
Time Frame
Between birth and 28 days of age
Title
Composite perinatal outcome
Description
Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death
Time Frame
Between birth and 28 days of age
Title
Maternal side effects
Time Frame
Maternal side effects

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-50 years of age Twin pregnancy (limits the participants to female gender) Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation Exclusion Criteria: Singleton or higher order than twins multiple gestation Monoamniotic twins Twin twin transfusion syndrome Ruptured membranes Lethal fetal structural anomaly Fetal chromosomal abnormality Cerclage in place (or planned placement) Vaginal bleeding Suspicion of chorioamnionitis Ballooning of membranes outside the cervix into the vagina Painful regular uterine contractions Labor 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
Email
gabriele.saccone@libero.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?

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