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

NCT02923973 | Recruiting

• 1 other identifier: #30/18
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Preterm delivery

  Less than 37 weeks gestation

Secondary Outcomes (7)

• Gestational age at delivery

  Time of delivery

• preterm birth rates

  Less than 24, 28, 34 weeks gestation

• Birth weight

  Time of delivery

• Low birth weight

  Time of delivery

• Neonatal death

  Between birth and 28 days of age

Study Arms (2)

TVU CL screening

EXPERIMENTAL

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

No TVU CL screening

NO INTERVENTION

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

Interventions

Transvaginal ultrasound cervical length screening OTHER

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

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 gestations
• Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead
• University of Pisa - Prof Paolo Mannella: collaborator

Study Sites (2)

Gabriele Saccone

Naples, 80100, Italy

RECRUITING

University of Pisa

Pisa, Italy

RECRUITING

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: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: June 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (2)