Prevention of Preterm Birth With a Pessary in Twin Gestations

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Preterm Birth With a Pessary in Twin Gestations

Conditions
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Premature Birth, Short Cervix

Intervention / Treatment
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* Device: Bioteque cup pessary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pessary<br>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) | Device: Bioteque cup pessary<br> <br> |
| No Intervention: No pessary<br>No pessary will be used. Subjects will receive standard obstetrical management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Preterm Delivery |  | Less than 34 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Spontaneous Preterm Birth Rates |  | 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. | Between birth and 28 days of age | 
| Number of Subjects Experiencing Chorioamnionitis | Chorioamnionitis was recorded and analyzed for participants in each group. | Time of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature birth, Premature delivery, Short cervix, Pessary