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

NCT02928302 | Withdrawn Phase 3

• 1 other identifier: 254/16
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• preterm birth rate

  either spontaneous or indicated preterm delivery

  Less than 37 weeks

Secondary Outcomes (12)

• Perinatal death

  Between birth and 28 days of age

• preterm birth rates

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

• admission to neonatal intensive care unit

  time of delivery

• Composite perinatal outcome

  Between birth and 28 days of age

• necrotizing enterocolitis

  Between birth and 28 days of age

Study Arms (2)

TVU CL screening

EXPERIMENTAL

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

Other: TVU CL screening

no screening

NO INTERVENTION

no TVU CL screening

Interventions

TVU CL screening OTHER

Transvaginal ultrasound cervical length screening

TVU CL screening

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Gabriele Saccone

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 10, 2016
• Study Start: July 23, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)