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

Not Applicable

• Conditions: Preterm Birth
• Interventions: Other: Transvaginal ultrasound cervical length screening

• Registration Number: NCT02923973
• Lead Sponsor: Federico II University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Study Start: 2018-06-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TVU CL screening	Transvaginal ultrasound cervical length 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

Primary Outcome Measures

Name	Time	Method
Preterm delivery	Less than 37 weeks gestation

Secondary Outcome Measures

Name	Time	Method
Low birth weight	Time of delivery	Birth weight \<2500g
Neonatal death	Between birth and 28 days of age
Composite adverse neonatal outcome	Between birth and 28 days of age	Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death
Admission to neonatal intensive care unit	Between birth and 28 days of age
Gestational age at delivery	Time of delivery
preterm birth rates	Less than 24, 28, 34 weeks gestation
Birth weight	Time of delivery

Trial Locations

Locations (2)

University of Pisa; 🇮🇹 Pisa, Italy

Gabriele Saccone; 🇮🇹 Naples, Italy