Premature Birth, Short Cervix
Conditions
Keywords
Premature birth, Premature delivery, Short cervix, Pessary
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.
Interventions
DEVICEBioteque cup pessary
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Preterm Delivery | Less than 34 weeks gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Birth Weight of Babies in Each Group | 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 | Less than 37 weeks gestation | — |
| Number of Participants That Experienced Neonatal Death | 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 of delivery | Chorioamnionitis was recorded and analyzed for participants in each group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 23 |
| No Pessary No pessary will be used. Subjects will receive standard obstetrical management | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Pessary | No Pessary | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 23 Participants | 46 Participants |
| Region of Enrollment United States | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 3 / 23 | 1 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Number of Participants With Preterm Delivery
Time frame: Less than 34 weeks gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Number of Participants With Preterm Delivery | 9 Participants |
| No Pessary | Number of Participants With Preterm Delivery | 8 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.
Time frame: Time of delivery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pessary | Average Birth Weight of Babies in Each Group | 2190 grams |
| No Pessary | Average Birth Weight of Babies in Each Group | 2220 grams |
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.
Time frame: Between birth and 28 days of age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Number of Participants That Experienced Neonatal Death | 4 Participants |
| No Pessary | Number of Participants That Experienced Neonatal Death | 3 Participants |
Secondary
Number of Subjects Experiencing Chorioamnionitis
Chorioamnionitis was recorded and analyzed for participants in each group.
Time frame: Time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Number of Subjects Experiencing Chorioamnionitis | 3 Participants |
| No Pessary | Number of Subjects Experiencing Chorioamnionitis | 0 Participants |
Secondary
Spontaneous Preterm Birth Rates
Time frame: Less than 37 weeks gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Spontaneous Preterm Birth Rates | 12 Participants |
| No Pessary | Spontaneous Preterm Birth Rates | 12 Participants |