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Prevention of Preterm Birth With a Pessary in Singleton Gestations (PoPPS)

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: NCT02056652
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 September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
Number of Subjects Experiencing Preterm Birth [ Time Frame: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks) ]
Birth before 37 weeks gestation was captured.
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
Preterm birth [ Time Frame: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • Average Birth Weight of Babies Born on Trial [ Time Frame: Time of delivery ]
    The birth weights of babies born in the pessary group was compared to those born in the no pessary group
  • Number of Participants That Experienced Spontaneous Preterm Births on Trial [ Time Frame: Before 37 weeks gestation ]
    The number of spontaneous births that occurred in participants on trial before 37 weeks was captured.
  • Number of Participants Experiencing Spontaneous Rupture of Membranes [ Time Frame: Less than 34 weeks gestation ]
    Rupture of membranes before 34 weeks gestation was captured in each group.
  • Number of Subjects Experiencing Neonatal Death [ Time Frame: Between birth and 28 days of age ]
    Number of participants who experienced neonatal deaths from birth to day 28 was captured for each group.
  • Number of Subjects Experiencing Chorioamnionitis [ Time Frame: Time of delivery ]
    The AE of Chorioamnionitis was captured for each group.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
  • Gestational age at delivery [ Time Frame: Time of delivery ]
  • Birth weight [ Time Frame: Time of delivery ]
  • Spontaneous preterm birth [ Time Frame: Before 24, 28, 34 and 37 weeks gestation ]
  • Spontaneous rupture of membranes [ Time Frame: Less than 34 weeks gestation ]
  • 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 birth [ Time Frame: Before 24, 28 and 34 weeks gestation ]
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 Singleton Gestations
Official Title  ICMJE Prevention of Preterm Birth With a Pessary in Singleton Gestations
Brief Summary Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. 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
  • Preterm 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 23 6/7 weeks gestation, and will be removed during the 37th 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: April 27, 2018)
122
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2014)
242
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
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 NCT02056652
Other Study ID Numbers  ICMJE 817797
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, MD Thomas Jefferson University
Principal Investigator: Jack Ludmir, MD 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