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Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth

Primary Purpose

Preterm Birth

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Transvaginal ultrasound cervical length screening

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

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

Inclusion Criteria:

18-50 years of age
Singleton gestations
Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks

Exclusion Criteria:

multiple gestation
Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization
Ballooning of membranes outside the cervix into the vagina at the time of randomization
Labor or cerclage in situ at the time of randomization

Sites / Locations

Gabriele SacconeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TVU CL screening

No TVU CL screening

Arm Description

TVU CL screening: serial TVU CL scan from 16 0/7 to 24 6/7 every week, for a total of nine scans Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery

no screening Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery

Outcomes

Primary Outcome Measures

Preterm delivery

Secondary Outcome Measures

Gestational age at delivery

preterm birth rates

Birth weight

Low birth weight

Birth weight <2500g

Neonatal death

Composite adverse neonatal outcome

Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death

Admission to neonatal intensive care unit

Full Information

NCT ID

NCT02923973

First Posted

October 3, 2016

Last Updated

February 20, 2020

Sponsor

Federico II University

1. Study Identification

Unique Protocol Identification Number

NCT02923973

Brief Title

Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth

Official Title

Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations. However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB

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

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TVU CL screening

Arm Type

Experimental

Arm Description

Arm Title

No TVU CL screening

Arm Type

No Intervention

Arm Description

no screening Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery

Intervention Type

Other

Intervention Name(s)

Transvaginal ultrasound cervical length screening

Intervention Description

Serial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks

Primary Outcome Measure Information:

Title

Preterm delivery

Time Frame

Less than 37 weeks gestation

Secondary Outcome Measure Information:

Title

Gestational age at delivery

Time Frame

Time of delivery

Title

preterm birth rates

Time Frame

Less than 24, 28, 34 weeks gestation

Title

Birth weight

Time Frame

Time of delivery

Title

Low birth weight

Description

Birth weight <2500g

Time Frame

Time of delivery

Title

Neonatal death

Time Frame

Between birth and 28 days of age

Title

Composite adverse neonatal outcome

Description

Time Frame

Between birth and 28 days of age

Title

Admission to neonatal intensive care unit

Time Frame

Between birth and 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: 18-50 years of age Singleton gestations Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks Exclusion Criteria: multiple gestation Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization Ballooning of membranes outside the cervix into the vagina at the time of randomization Labor or cerclage in situ at the time of randomization

Facility Information:

Facility Name

Gabriele Saccone

City

Naples

ZIP/Postal Code

80100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabriele Saccone

Phone

0817461111

gabriele.saccone.1990@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth

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