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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02923973
• Other study ID #: #30/18
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• Transvaginal ultrasound cervical length screening
Serial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks

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 delivery		Less than 37 weeks gestation
Secondary	Gestational age at delivery		Time of delivery
Secondary	preterm birth rates		Less than 24, 28, 34 weeks gestation
Secondary	Birth weight		Time of delivery
Secondary	Low birth weight	Birth weight <2500g	Time of delivery
Secondary	Neonatal death		Between birth and 28 days of age
Secondary	Composite adverse neonatal outcome	Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death	Between birth and 28 days of age
Secondary	Admission to neonatal intensive care unit		Between birth and 28 days of age