Trial record 2 of 755 for:    preterm birth

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Lorraine Dugoff, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02056652
First received: February 4, 2014
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention
Preterm Birth
Short Cervix
Device: Bioteque cup pessary

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Preterm Birth With a Pessary in Singleton Gestations

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Preterm birth [ Time Frame: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gestational age at delivery [ Time Frame: Time of delivery ] [ Designated as safety issue: No ]
  • Birth weight [ Time Frame: Time of delivery ] [ Designated as safety issue: No ]
  • Spontaneous preterm birth [ Time Frame: Before 24, 28, 34 and 37 weeks gestation ] [ Designated as safety issue: No ]
  • Spontaneous rupture of membranes [ Time Frame: Less than 34 weeks gestation ] [ Designated as safety issue: No ]
  • Neonatal death [ Time Frame: Between birth and 28 days of age ] [ Designated as safety issue: Yes ]
  • Composite adverse neonatal outcome [ Time Frame: Between birth and 28 days of age ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Significant adverse maternal effects [ Time Frame: Time of delivery ] [ Designated as safety issue: Yes ]
    Includes heavy bleeding, cervical tear and uterine rupture

  • Intolerance to pessary [ Time Frame: Prior to delivery ] [ Designated as safety issue: Yes ]
    Defined as request for removal secondary to discomfort and/or discharge

  • Preterm birth [ Time Frame: Before 24, 28 and 34 weeks gestation ] [ Designated as safety issue: No ]

Estimated Enrollment: 242
Study Start Date: February 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056652

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lorraine Dugoff       Lorraine.Dugoff@uphs.upenn.edu   
Principal Investigator: Lorraine Dugoff, MD         
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jack Ludmir       jaludm@uphs.upenn.edu   
Sub-Investigator: Jack Ludmir, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Vincenzo Berghella       Vincenzo.Berghella@jefferson.edu   
Principal Investigator: Vincenzo Berghella, MD         
Sponsors and Collaborators
Lorraine Dugoff
Investigators
Principal Investigator: Lorraine Dugoff, MD University of Pennsylvania
Principal Investigator: Vincenzo Berghella, MD Thomas Jefferson University
Principal Investigator: Jack Ludmir, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Lorraine Dugoff, Associate Professor of Obstetrics and Gynecology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02056652     History of Changes
Other Study ID Numbers: 817797
Study First Received: February 4, 2014
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 21, 2014