Skip to main content
Clinical Trials/NCT02056639
NCT02056639
Completed
Not Applicable

Prevention of Preterm Birth With a Pessary in Twin Gestations

University of Pennsylvania3 sites in 1 country46 target enrollmentFebruary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
University of Pennsylvania
Enrollment
46
Locations
3
Primary Endpoint
Number of Participants With Preterm Delivery
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
October 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of Participants With Preterm Delivery

Time Frame: Less than 34 weeks gestation

Secondary Outcomes

  • Average Birth Weight of Babies in Each Group(Time of delivery)
  • Number of Participants That Experienced Neonatal Death(Between birth and 28 days of age)
  • Number of Subjects Experiencing Chorioamnionitis(Time of delivery)
  • Spontaneous Preterm Birth Rates(Less than 37 weeks gestation)

Study Sites (3)

Loading locations...

Similar Trials