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

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

Study Overview

• Status: Withdrawn
• Conditions: Preterm Birth
• Intervention / Treatment: Other: TVU CL screening

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • Gabriele Saccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TVU CL screening; TVU CL screening: single TVU CL at 18 0/7 to 23 6/7 every week	Other: TVU CL screening; Transvaginal ultrasound cervical length screening
No Intervention: no screening; no TVU CL screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preterm birth rate	either spontaneous or indicated preterm delivery	Less than 37 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal death		Between birth and 28 days of age
birth weight		time of delivery
admission to neonatal intensive care unit		time of delivery
Perinatal death	either neonatal death or fetal death	Between birth and 28 days of age
preterm birth rates	either spontaneous or indicated preterm delivery	Less than 24, 28, 32, 30, and 34 weeks gestation
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	Between birth and 28 days of age
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	Between birth and 28 days of age
intraventricular hemorrhage (grade 3 or higher)	IVH	Between birth and 28 days of age
respiratory distress syndrome	Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates	Time of delivery
Length of hospital stay	Days in NICU	Discharge from hospital
gestational age at delivery		time of delivery
latency	from randomization to delivery	time of delivery

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 254/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No