Clinical trial NCT02056639: Prevention of Preterm Birth With a Pessary in Twin Gestations
Official title: Prevention of Preterm Birth With a Pessary in Twin Gestations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Short Cervix
Keywords: Premature birth
Premature delivery
Short cervix
Pessary
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
* Painful regular uterine contractions
* Labor
* Placenta previa

Primary outcomes:
measure: Number of Participants With Preterm Delivery
timeFrame: Less than 34 weeks gestation
Secondary outcomes:
measure: Average Birth Weight of Babies in Each Group
timeFrame: Time of delivery
measure: Spontaneous Preterm Birth Rates
timeFrame: Less than 37 weeks gestation
measure: Number of Participants That Experienced Neonatal Death
timeFrame: Between birth and 28 days of age
measure: Number of Subjects Experiencing Chorioamnionitis
timeFrame: Time of delivery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Lorraine Dugoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Vincenzo Berghella
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Jack Ludmir
role: PRINCIPAL_INVESTIGATOR
References: