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

Federico II University

Status and phase: Withdrawn; Phase 3

Conditions: Preterm Birth

Treatments: Other: TVU CL screening

Study type: Interventional

Funder types: Other

Identifiers

NCT02928302

254/16

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

TVU CL screening

Experimental group

Description:

TVU CL screening: single TVU CL at 18 0/7 to 23 6/7 every week

Treatment:

Other: TVU CL screening

no screening

No Intervention group

Description:

no TVU CL screening