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

Federico II University

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Conditions

Preterm Birth

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

preterm birth rate

either spontaneous or indicated preterm delivery

Time frame: Less than 37 weeks

Secondary Outcomes

Perinatal death

either neonatal death or fetal death

Time frame: Between birth and 28 days of age

preterm birth rates

either spontaneous or indicated preterm delivery

Time frame: Less than 24, 28, 32, 30, and 34 weeks gestation

admission to neonatal intensive care unit

Time frame: time of delivery

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

Time frame: Between birth and 28 days of age

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

Time frame: Between birth and 28 days of age

intraventricular hemorrhage (grade 3 or higher)

IVH

Time frame: Between birth and 28 days of age

respiratory distress syndrome

Respiratory distress with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates

Time frame: Time of delivery

birth weight

Time frame: time of delivery

Length of hospital stay

Days in NICU

Time frame: Discharge from hospital

Neonatal death

Time frame: Between birth and 28 days of age

gestational age at delivery

Time frame: time of delivery

latency

from randomization to delivery

Time frame: time of delivery

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes