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

NCT ID: NCT02928302

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2020-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

TVU CL screening

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

Group Type: EXPERIMENTAL

TVU CL screening

Intervention Type: OTHER

Transvaginal ultrasound cervical length screening

no screening

no TVU CL screening

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TVU CL screening

Transvaginal ultrasound cervical length screening

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Saccone

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriele Saccone

Naples, , Italy

Countries

Italy

Other Identifiers

254/16

Identifier Type: -

Identifier Source: org_study_id