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

Phase 3

Withdrawn

• Conditions: Preterm Birth
• Interventions: Other: TVU CL screening

• Registration Number: NCT02928302
• Lead Sponsor: Federico II University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-06
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-10
• Study Start: 2018-07-23
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
preterm birth rate	Less than 37 weeks	either spontaneous or indicated preterm delivery

Secondary Outcome Measures

Name	Time	Method
Neonatal death	Between birth and 28 days of age
necrotizing enterocolitis	Between birth and 28 days of age	Defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation
Perinatal death	Between birth and 28 days of age	either neonatal death or fetal death
gestational age at delivery	time of delivery
latency	time of delivery	from randomization to delivery
admission to neonatal intensive care unit	time of delivery
intraventricular hemorrhage (grade 3 or higher)	Between birth and 28 days of age	IVH
preterm birth rates	Less than 24, 28, 32, 30, and 34 weeks gestation	either spontaneous or indicated preterm delivery
Composite perinatal outcome	Between birth and 28 days of age	Includes necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH) (grade 3 or higher), respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), retinopathy (ROP), blood-culture proven sepsis and neonatal death
Length of hospital stay	Discharge from hospital	Days in NICU
respiratory distress syndrome	Time of delivery	Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates
birth weight	time of delivery

Trial Locations

Locations (1)

Gabriele Saccone; 🇮🇹 Naples, Italy