Prevention of Preterm Birth With a Pessary in Twin Gestations

Premature Birth Clinical Trial

— PoPPT  

Official title:

Prevention of Preterm Birth With a Pessary in Twin Gestations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056639
• Other study ID #: 819122
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: October 2016

Study information

• Verified date: April 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Short Cervix

Intervention

Device:
• Bioteque cup pessary

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Preterm Delivery		Less than 34 weeks gestation
Secondary	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
Secondary	Spontaneous Preterm Birth Rates		Less than 37 weeks gestation
Secondary	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
Secondary	Number of Subjects Experiencing Chorioamnionitis	Chorioamnionitis was recorded and analyzed for participants in each group.	Time of delivery