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Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716909
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriele Saccone, Federico II University

Brief Summary:

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.

The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with a short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on the use of cervical pessary in pregnancy or guidelines for management have been assessed.


Condition or disease Intervention/treatment Phase
Preterm Birth Device: Cervical pessary Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pessary in Singleton Gestations With Short Cervix Without Prior Preterm Birth
Study Start Date : March 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: Cervical Pessary
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
Device: Cervical pessary
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)

No Intervention: No intervention
No pessary No pessary will be used. Subjects will receive standard obstetrical management



Primary Outcome Measures :
  1. Spontaneous preterm birth (SPTB) <34 weeks [ Time Frame: Less than 34 weeks gestation ]
    Spontaneous preterm delivery less than 34 weeks of gestation


Secondary Outcome Measures :
  1. SPTB <37w [ Time Frame: Less than 37 weeks gestation ]
  2. SPTB <32w [ Time Frame: Less than 32 weeks gestation ]
  3. SPTB <28w [ Time Frame: Less than 32 weeks gestation ]
  4. Gestational age at delivery [ Time Frame: Time of delivery ]
  5. Latency [ Time Frame: time of delivery ]
    interval from randomization to delivery in days

  6. preterm premature rupture of membranes [ Time Frame: Less than 34 weeks gestation ]
  7. Type of delivery [ Time Frame: time of delivery ]
    Cesarean delivery, operative vaginal delivery and spontaneous vaginal delivery

  8. Maternal side effects [ Time Frame: Time of delivery ]
    Vaginal discharge, bacterial vaginosis

  9. Birth weight [ Time Frame: Time of delivery ]
  10. Neonatal death [ Time Frame: Between birth and 28 days of age ]
  11. perinatal death [ Time Frame: fetal death after 20 weeks ]
    either fetal mortality or neonatal death

  12. Composite adverse perinatal 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

  13. Chorioamnionitis [ Time Frame: Time of delivery ]
  14. Adminssion 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 pregnancy (limits the participants to female gender)
  • Short cervical length (less than or equal to 25 mm) on second trimester transvaginal ultrasound at 18-23 6/7 weeks gestation

Exclusion Criteria:

  • Multiple gestation
  • Prior spontaneous preterm birth 16-36 6/7 weeks
  • Ruptured membranes
  • Lethal fetal structural anomaly
  • Fetal chromosomal abnormality
  • Cerclage in place (or planned placement)
  • Vaginal bleeding
  • Suspicion of chorioamnionitis
  • Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
  • Painful regular uterine contractions
  • Placenta previa

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): NCT02716909


Locations
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Italy
Gabriele Saccone
Napoli, Italy, 80129
Sponsors and Collaborators
Federico II University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gabriele Saccone, Medical Doctor, Federico II University
ClinicalTrials.gov Identifier: NCT02716909    
Other Study ID Numbers: 213/2015
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications