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

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.

Condition or disease Intervention/treatment Phase
Premature Birth Short Cervix Device: Bioteque cup pessary Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Preterm Birth With a Pessary in Twin Gestations
Actual Study Start Date : February 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
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)
Device: Bioteque cup pessary
No Intervention: No pessary
No pessary will be used. Subjects will receive standard obstetrical management

Primary Outcome Measures :
  1. Number of Participants With Preterm Delivery [ Time Frame: Less than 34 weeks gestation ]

Secondary Outcome Measures :
  1. 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.

  2. Spontaneous Preterm Birth Rates [ Time Frame: Less than 37 weeks gestation ]
  3. 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.

  4. Number of Subjects Experiencing Chorioamnionitis [ Time Frame: Time of delivery ]
    Chorioamnionitis was recorded and analyzed for participants in each group.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT02056639

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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Lorraine Dugoff, MD University of Pennsylvania
Principal Investigator: Vincenzo Berghella Thomas Jefferson University
Principal Investigator: Jack Ludmir University of Pennsylvania
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Responsible Party: University of Pennsylvania Identifier: NCT02056639    
Other Study ID Numbers: 819122
First Posted: February 6, 2014    Key Record Dates
Results First Posted: May 29, 2018
Last Update Posted: May 29, 2018
Last Verified: April 2018
Keywords provided by University of Pennsylvania:
Premature birth
Premature delivery
Short cervix
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications