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Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth

Primary Purpose

Preterm Birth

Status

Withdrawn

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

TVU CL screening

About this trial

This is an interventional screening trial for Preterm Birth

Eligibility Criteria

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

Inclusion Criteria:

18-50 years of age
Singleton pregnancy (limits the participants to female gender)
No prior spontaneous preterm delivery, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks

Exclusion Criteria:

Multiple gestation
Prior spontaneous preterm birth 16-36 6/7 weeks
Ruptured membranes at time of randomization
Lethal fetal structural anomaly at time of randomization
Fetal chromosomal abnormality at time of randomization
Placenta previa and/or accreta at time of randomization
Women who already underwent TVU CL measurement during the index pregnancy

Sites / Locations

Gabriele Saccone

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TVU CL screening

no screening

Arm Description

TVU CL screening: single TVU CL at 18 0/7 to 23 6/7 every week

no TVU CL screening

Outcomes

Primary Outcome Measures

preterm birth rate

either spontaneous or indicated preterm delivery

Secondary Outcome Measures

Perinatal death

either neonatal death or fetal death

preterm birth rates

either spontaneous or indicated preterm delivery

admission to neonatal intensive care unit

Composite perinatal outcome

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

necrotizing enterocolitis

Defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation

intraventricular hemorrhage (grade 3 or higher)

IVH

respiratory distress syndrome

Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates

birth weight

Length of hospital stay

Days in NICU

Neonatal death

gestational age at delivery

latency

from randomization to delivery

Full Information

NCT ID

NCT02928302

First Posted

October 6, 2016

Last Updated

November 15, 2018

Sponsor

Federico II University

1. Study Identification

Unique Protocol Identification Number

NCT02928302

Brief Title

Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth

Official Title

Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Withdrawn

Why Stopped

new protocol started 31/18

Study Start Date

July 23, 2018 (Actual)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

December 2020 (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 a 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, we aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy without 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

Screening

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TVU CL screening

Arm Type

Experimental

Arm Description

TVU CL screening: single TVU CL at 18 0/7 to 23 6/7 every week

Arm Title

no screening

Arm Type

No Intervention

Arm Description

no TVU CL screening

Intervention Type

Other

Intervention Name(s)

TVU CL screening

Intervention Description

Transvaginal ultrasound cervical length screening

Primary Outcome Measure Information:

Title

preterm birth rate

Description

either spontaneous or indicated preterm delivery

Time Frame

Less than 37 weeks

Secondary Outcome Measure Information:

Title

Perinatal death

Description

either neonatal death or fetal death

Time Frame

Between birth and 28 days of age

Title

preterm birth rates

Description

either spontaneous or indicated preterm delivery

Time Frame

Less than 24, 28, 32, 30, and 34 weeks gestation

Title

admission to neonatal intensive care unit

Time Frame

time of delivery

Title

Composite perinatal outcome

Description

Time Frame

Between birth and 28 days of age

Title

necrotizing enterocolitis

Description

Time Frame

Between birth and 28 days of age

Title

intraventricular hemorrhage (grade 3 or higher)

Description

IVH

Time Frame

Between birth and 28 days of age

Title

respiratory distress syndrome

Description

Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates

Time Frame

Time of delivery

Title

birth weight

Time Frame

time of delivery

Title

Length of hospital stay

Description

Days in NICU

Time Frame

Discharge from hospital

Title

Neonatal death

Time Frame

Between birth and 28 days of age

Title

gestational age at delivery

Time Frame

time of delivery

Title

latency

Description

from randomization to delivery

Time Frame

time of delivery

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 pregnancy (limits the participants to female gender) No prior spontaneous preterm delivery, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks Exclusion Criteria: Multiple gestation Prior spontaneous preterm birth 16-36 6/7 weeks Ruptured membranes at time of randomization Lethal fetal structural anomaly at time of randomization Fetal chromosomal abnormality at time of randomization Placenta previa and/or accreta at time of randomization Women who already underwent TVU CL measurement during the index pregnancy

Facility Information:

Facility Name

Gabriele Saccone

City

Naples

ZIP/Postal Code

80100

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

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Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth

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