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

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

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Other: Transvaginal ultrasound cervical length screening

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • Recruiting
    • Gabriele Saccone
    • Contact: Gabriele Saccone; Phone Number: 0817461111; Email: gabriele.saccone.1990@gmail.com
  • Pisa, Italy
    • Recruiting
    • University of Pisa
    • Contact: Paolo Mannella, MD; Phone Number: 000; Email: paolo.mannella@unipi.it
    • Principal Investigator: Paolo Mannella, MD

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TVU CL screening; 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	Other: Transvaginal ultrasound cervical length screening; Serial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks
No Intervention: No TVU CL screening; no screening Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preterm delivery	Less than 37 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at delivery		Time of delivery
Birth weight		Time of delivery
Neonatal death		Between birth and 28 days of age
Low birth weight	Birth weight <2500g	Time of delivery
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	Between birth and 28 days of age
Admission to neonatal intensive care unit		Between birth and 28 days of age
preterm birth rates		Less than 24, 28, 34 weeks gestation

Collaborators and Investigators

• Sponsor: Federico II University
• Collaborators: University of Pisa - Prof Paolo Mannella

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimated): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: #30/18

Drug and device information, study documents

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