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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02928302
• Other study ID #: 254/16
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 23, 2018
• Est. completion date: December 2020

Study information

• Verified date: November 2018
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• TVU CL screening
Transvaginal ultrasound cervical length screening

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preterm birth rate	either spontaneous or indicated preterm delivery	Less than 37 weeks
Secondary	Perinatal death	either neonatal death or fetal death	Between birth and 28 days of age
Secondary	preterm birth rates	either spontaneous or indicated preterm delivery	Less than 24, 28, 32, 30, and 34 weeks gestation
Secondary	admission to neonatal intensive care unit		time of delivery
Secondary	Composite perinatal outcome	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	Between birth and 28 days of age
Secondary	necrotizing enterocolitis	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	Between birth and 28 days of age
Secondary	intraventricular hemorrhage (grade 3 or higher)	IVH	Between birth and 28 days of age
Secondary	respiratory distress syndrome	Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates	Time of delivery
Secondary	birth weight		time of delivery
Secondary	Length of hospital stay	Days in NICU	Discharge from hospital
Secondary	Neonatal death		Between birth and 28 days of age
Secondary	gestational age at delivery		time of delivery
Secondary	latency	from randomization to delivery	time of delivery