Overview

This trial is active, not recruiting.

Conditions premature birth, short cervix
Treatment bioteque cup pessary
Sponsor University of Pennsylvania
Start date February 2014
End date August 2016
Trial size 46 participants
Trial identifier NCT02056639, 819122

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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)
bioteque cup pessary
(No Intervention)
No pessary will be used. Subjects will receive standard obstetrical management

Primary Outcomes

Measure
Preterm delivery
time frame: Less than 34 weeks gestation

Secondary Outcomes

Measure
Gestational age
time frame: Time of delivery
Birth weight
time frame: Time of delivery
Spontaneous preterm birth rates
time frame: Less than 24, 28, 34 and 37 weeks gestation
Spontaneous rupture of membranes
time frame: Less than 34 weeks gestation
Cesarean section rate
time frame: Time of delivery
Neonatal death
time frame: Between birth and 28 days of age
Composite adverse neonatal outcome
time frame: Between birth and 28 days of age
Chorioamnionitis
time frame: Time of delivery
Significant adverse maternal effects
time frame: Time of delivery
Intolerance to pessary
time frame: Prior to delivery
Preterm delivery
time frame: Less than 24, 28 and 37 weeks

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

Official title Prevention of Preterm Birth With a Pessary in Twin Gestations
Principal investigator Lorraine Dugoff, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.