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

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ClinicalTrials.gov Identifier: NCT02056652
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Preterm Birth With a Pessary in Singleton Gestations
Actual Study Start Date : February 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
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)
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 Subjects Experiencing Preterm Birth [ Time Frame: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks) ]
    Birth before 37 weeks gestation was captured.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. Number of Subjects Experiencing Chorioamnionitis [ Time Frame: Time of delivery ]
    The AE of Chorioamnionitis was captured for each group.



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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 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): NCT02056652


Locations
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United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
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
Investigators
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Principal Investigator: Lorraine Dugoff, MD University of Pennsylvania
Principal Investigator: Vincenzo Berghella, MD Thomas Jefferson University
Principal Investigator: Jack Ludmir, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02056652     History of Changes
Other Study ID Numbers: 817797
First Posted: February 6, 2014    Key Record Dates
Results First Posted: May 28, 2018
Last Update Posted: May 28, 2018
Last Verified: April 2018

Keywords provided by University of Pennsylvania:
Preterm birth
Preterm delivery
short cervix
pessary

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications