Clinical trial NCT02928302: Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth
Official title: Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy Without Prior Spontaneous Preterm Birth
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Preterm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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


Eligibility criteria: 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

Primary outcomes:
measure: preterm birth rate
timeFrame: Less than 37 weeks
Secondary outcomes:
measure: Perinatal death
timeFrame: Between birth and 28 days of age
measure: preterm birth rates
timeFrame: Less than 24, 28, 32, 30, and 34 weeks gestation
measure: admission to neonatal intensive care unit
timeFrame: time of delivery
measure: Composite perinatal outcome
timeFrame: Between birth and 28 days of age
measure: necrotizing enterocolitis
timeFrame: Between birth and 28 days of age
measure: intraventricular hemorrhage (grade 3 or higher)
timeFrame: Between birth and 28 days of age
measure: respiratory distress syndrome
timeFrame: Time of delivery
measure: birth weight
timeFrame: time of delivery
measure: Length of hospital stay
timeFrame: Discharge from hospital
measure: Neonatal death
timeFrame: Between birth and 28 days of age
measure: gestational age at delivery
timeFrame: time of delivery
measure: latency
timeFrame: time of delivery
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Gabriele Saccone
Study officials:
References: