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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pessary | 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) |
|
| No pessary | No Intervention | No pessary will be used. Subjects will receive standard obstetrical management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioteque cup pessary | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Preterm Delivery | Less than 34 weeks gestation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorraine Dugoff, MD | University of Pennsylvania | Principal Investigator |
| Vincenzo Berghella | Thomas Jefferson University | Principal Investigator |
| Jack Ludmir | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| Pennsylvania Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pessary | 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 |
| FG001 | No Pessary | No pessary will be used. Subjects will receive standard obstetrical management |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pessary | 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 |
| BG001 | No Pessary |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Preterm Delivery | Posted | Count of Participants | Participants | Less than 34 weeks gestation |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pessary | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| UTI | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
The main limitation of our study was the fact that it was stopped before planned enrollment was complete, which resulted in a small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bridget Nolan | University of Pennsylvania | 2156623324 | bridget.nolan@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
No pessary will be used. Subjects will receive standard obstetrical management
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | Full Range | grams | Time of delivery |
|
|
|
| Secondary | Spontaneous Preterm Birth Rates | Posted | Count of Participants | Participants | Less than 37 weeks gestation |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Between birth and 28 days of age |
|
|
|
| Secondary | Number of Subjects Experiencing Chorioamnionitis | Chorioamnionitis was recorded and analyzed for participants in each group. | Posted | Count of Participants | Participants | Time of delivery |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 3 |
| 23 |
| EG001 | No Pessary | No pessary will be used. Subjects will receive standard obstetrical management | 0 | 23 | 0 | 23 | 1 | 23 |
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| D000091642 | Urogenital Diseases |