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Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth

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ClinicalTrials.gov Identifier: NCT02923973
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Gabriele Saccone, Federico II University

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Preterm Birth Other: Transvaginal ultrasound cervical length screening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: TVU CL screening
TVU CL screening: serial TVU CL scan from 16 0/7 to 24 6/7 every week, for a total of nine scans Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery
Other: Transvaginal ultrasound cervical length screening
Serial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks

No Intervention: No TVU CL screening
no screening Vaginal progesterone 200mg suppository daily from 14 0/7 to 20 6/7 weeks for the history of prior spontaneous preterm delivery



Primary Outcome Measures :
  1. Preterm delivery [ Time Frame: Less than 37 weeks gestation ]

Secondary Outcome Measures :
  1. Gestational age at delivery [ Time Frame: Time of delivery ]
  2. preterm birth rates [ Time Frame: Less than 24, 28, 34 weeks gestation ]
  3. Birth weight [ Time Frame: Time of delivery ]
  4. Low birth weight [ Time Frame: Time of delivery ]
    Birth weight <2500g

  5. Neonatal death [ Time Frame: Between birth and 28 days of age ]
  6. Composite adverse neonatal outcome [ Time Frame: Between birth and 28 days of age ]
    Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia (BPD), retinopathy, blood-culture proven sepsis and neonatal death

  7. Admission to neonatal intensive care unit [ Time Frame: Between birth and 28 days of age ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-50 years of age
  • Singleton gestations
  • Women with prior spontaneous preterm birth, defined as spontaneous preterm delivery 16 0/7 - 36 6/7 weeks

Exclusion Criteria:

  • multiple gestation
  • Ruptured membranes or fetal structural or chromosomal abnormality at the time of randomization
  • Ballooning of membranes outside the cervix into the vagina at the time of randomization
  • Labor or cerclage in situ at the time of randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923973


Locations
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Italy
Gabriele Saccone Recruiting
Naples, Italy, 80100
Contact: Gabriele Saccone    0817461111    gabriele.saccone.1990@gmail.com   
Sponsors and Collaborators
Federico II University

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Responsible Party: Gabriele Saccone, MD, Federico II University
ClinicalTrials.gov Identifier: NCT02923973    
Other Study ID Numbers: #30/18
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications