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

NCT ID: NCT02923973

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2025-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Transvaginal ultrasound cervical length screening

Intervention Type: OTHER

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transvaginal ultrasound cervical length screening

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa - Prof Paolo Mannella

UNKNOWN

Sponsor Role: collaborator

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Saccone

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriele Saccone

Naples, , Italy

Site Status: RECRUITING

University of Pisa

Pisa, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Gabriele Saccone

Role: primary

gabriele.saccone.1990@gmail.com

0817461111

Paolo Mannella, MD

Role: primary

paolo.mannella@unipi.it

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Other Identifiers

#30/18

Identifier Type: -

Identifier Source: org_study_id