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Prevention of Preterm Birth With a Pessary in Twin Gestations (PoPPT)

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: NCT02056639
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : May 29, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE February 4, 2014
First Posted Date  ICMJE February 6, 2014
Results First Submitted Date  ICMJE October 24, 2017
Results First Posted Date  ICMJE May 29, 2018
Last Update Posted Date May 29, 2018
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
Number of Participants With Preterm Delivery [ Time Frame: Less than 34 weeks gestation ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
Preterm delivery [ Time Frame: Less than 34 weeks gestation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Average Birth Weight of Babies in Each Group [ Time Frame: Time of delivery ]
    The birth weight of babies is the pessary group and no pessary group were recorded and analyzed for comparison.
  • Spontaneous Preterm Birth Rates [ Time Frame: Less than 37 weeks gestation ]
  • Number of Participants That Experienced Neonatal Death [ Time Frame: Between birth and 28 days of age ]
    Number of participants that experienced neonatal deaths that occurred in each group following birth was recorded and analyzed.
  • Number of Subjects Experiencing Chorioamnionitis [ Time Frame: Time of delivery ]
    Chorioamnionitis was recorded and analyzed for participants in each group.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
  • Gestational age [ Time Frame: Time of delivery ]
  • Birth weight [ Time Frame: Time of delivery ]
  • Spontaneous Preterm Birth Rates [ Time Frame: Less than 24, 28, 34 and 37 weeks gestation ]
  • Spontaneous rupture of membranes [ Time Frame: Less than 34 weeks gestation ]
  • Cesarean section rate [ Time Frame: Time of delivery ]
  • Neonatal death [ Time Frame: Between birth and 28 days of age ]
  • 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
  • Chorioamnionitis [ Time Frame: Time of delivery ]
  • Significant adverse maternal effects [ Time Frame: Time of delivery ]
    Includes heavy bleeding, cervical tear and uterine rupture
  • Intolerance to pessary [ Time Frame: Prior to delivery ]
    Defined as request for removal secondary to discomfort and/or discharge
  • Preterm delivery [ Time Frame: Less than 24, 28 and 37 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Preterm Birth With a Pessary in Twin Gestations
Official Title  ICMJE Prevention of Preterm Birth With a Pessary in Twin Gestations
Brief Summary Preterm birth (PTB) is a major health problem and contributes to more than 50% of the overall perinatal mortality. Twins are at increased risk for PTB. The number of twins births has risen substantially due to the increased use of assisted reproductive technology. The rate of twin births in the United States rose from 18.9 to 32.2 per 100 live births between 1980 and 2004. The increased rate of PTB in twins is associated with increased morbidity and mortality rates. Almost one in four very low birth-weight infants (below 1500 g) born in the United States are twins, as are one in six infants who die in the first month of life. Cervical shortening is a risk factor for PTB. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. There is currently no effective treatment to decrease the incidence of PTB in women with twin gestations, but there is some evidence that the use of a cervical pessary in women with a short cervix has promise. If effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. Unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. We propose such a trial to study the effectiveness of the pessary in decreasing the incidence of PTB in an inner city Philadelphia population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Premature Birth
  • Short Cervix
Intervention  ICMJE Device: Bioteque cup pessary
Study Arms  ICMJE
  • Experimental: Pessary
    Use of the Bioteque cup pessary. Pessary will be placed between 18 and 27 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)
    Intervention: Device: Bioteque cup pessary
  • No Intervention: No pessary
    No pessary will be used. Subjects will receive standard obstetrical management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2016)
46
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2014)
164
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-50 years of age
  • Twin pregnancy (limits the participants to female gender)
  • Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-27 6/7 weeks gestation

Exclusion Criteria:

  • Singleton or higher order than twins multiple gestation
  • Monoamniotic twins
  • Twin twin transfusion syndrome
  • 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
  • Painful regular uterine contractions
  • Labor
  • Placenta previa
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02056639
Other Study ID Numbers  ICMJE 819122
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lorraine Dugoff, MD University of Pennsylvania
Principal Investigator: Vincenzo Berghella Thomas Jefferson University
Principal Investigator: Jack Ludmir University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP