Prevention of Preterm Birth With a Pessary in Twin Gestations (PoPPT)

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth; Short Cervix
• Intervention / Treatment: Device: Bioteque cup pessary

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Preterm Delivery	Less than 34 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Birth Weight of Babies in Each Group	The birth weight of babies is the pessary group and no pessary group were recorded and analyzed for comparison.	Time of delivery
Spontaneous Preterm Birth Rates		Less than 37 weeks gestation
Number of Participants That Experienced Neonatal Death	Number of participants that experienced neonatal deaths that occurred in each group following birth was recorded and analyzed.	Between birth and 28 days of age
Number of Subjects Experiencing Chorioamnionitis	Chorioamnionitis was recorded and analyzed for participants in each group.	Time of delivery

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Lorraine Dugoff, MD, University of Pennsylvania; Principal Investigator: Vincenzo Berghella, Thomas Jefferson University; Principal Investigator: Jack Ludmir, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 6, 2014

Study Record Updates

• Last Update Posted (Actual): May 29, 2018
• Last Update Submitted That Met QC Criteria: April 27, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Premature birth; Premature delivery; Short cervix; Pessary
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 819122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No