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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
46
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Number of Participants With Preterm Delivery
Time frame: Less than 34 weeks gestation
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 frame: Time of delivery
Spontaneous Preterm Birth Rates
Time frame: 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.
Time frame: Between birth and 28 days of age
Number of Subjects Experiencing Chorioamnionitis
Chorioamnionitis was recorded and analyzed for participants in each group.
Time frame: Time of delivery
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