Actively Recruiting
Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
Led by Federico II University · Updated on 2024-09-19
500
Participants Needed
2
Research Sites
352 weeks
Total Duration
On this page
Sponsors
F
Federico II University
Lead Sponsor
U
University of Pisa - Prof Paolo Mannella
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18-50 years of age
- Singleton pregnancies
- Women with a prior spontaneous preterm birth between 16 0/7 and 36 6/7 weeks
You will not qualify if you...
- Multiple pregnancies
- Ruptured membranes or fetal structural or chromosomal abnormalities at randomization
- Ballooning of membranes outside the cervix into the vagina at randomization
- Labor or cerclage in place at randomization
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Trial Site Locations
Total: 2 locations
1
Gabriele Saccone
Naples, Italy, 80100
Actively Recruiting
2
University of Pisa
Pisa, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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