NCT Number: NCT02056639
Prevention of Preterm Birth With a Pessary in Twin Gestations
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.
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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Number of Participants With Preterm Delivery
Time frame: Less than 34 weeks gestation
Secondary outcomes
-
Average Birth Weight of Babies in Each Group
Time frame: Time of delivery
The birth weight of babies is the pessary group and no pessary group were recorded and analyzed for comparison.
-
Spontaneous Preterm Birth Rates
Time frame: Less than 37 weeks gestation
-
Number of Participants That Experienced Neonatal Death
Time frame: Between birth and 28 days of age
Number of participants that experienced neonatal deaths that occurred in each group following birth was recorded and analyzed.
-
Number of Subjects Experiencing Chorioamnionitis
Time frame: Time of delivery
Chorioamnionitis was recorded and analyzed for participants in each group.
Sponsors and collaborators
Lead sponsor
University of Pennsylvania
Other
Registry information
Acronym: PoPPT
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Feb 6, 2014
- Registry last updated
- May 29, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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