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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02928302
Other study ID # 254/16
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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