Preterm Birth, Short Cervix
Conditions
Keywords
Preterm birth, Preterm delivery, short cervix, pessary
Brief summary
Preterm birth (PTB) is associated with over one million infant deaths annually worldwide. The incidence of PTB in the United States is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. The rate of PTB in the United States increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay PTB. Weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of PTB and is currently recommended for women who experienced spontaneous PTB in a prior pregnancy. However, a strategy for the prevention of spontaneous PTBs in which therapeutic intervention is restricted to women with a previous PTB is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous PTBs arise in women with such a history. A major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous PTB and through the development of an effective prevention for this complication. Transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of PTB. Although treatment with vaginal progesterone is effective in decreasing PTB in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. Preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing PTB. 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 * Singleton pregnancy (limits the participants to female gender) * Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
Exclusion criteria
* Multiple gestation * Prior spontaneous preterm birth 16-36 6/7 weeks * 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 or CL = 0 mm on transvaginal ultrasound * Painful regular uterine contractions * Placenta previa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing Preterm Birth | Before 37 weeks gestation (20 0/7 - 36 6/7 weeks) | Birth before 37 weeks gestation was captured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Birth Weight of Babies Born on Trial | Time of delivery | The birth weights of babies born in the pessary group was compared to those born in the no pessary group |
| Number of Participants That Experienced Spontaneous Preterm Births on Trial | Before 37 weeks gestation | The number of spontaneous births that occurred in participants on trial before 37 weeks was captured. |
| Number of Participants Experiencing Spontaneous Rupture of Membranes | Less than 34 weeks gestation | Rupture of membranes before 34 weeks gestation was captured in each group. |
| Number of Subjects Experiencing Neonatal Death | Between birth and 28 days of age | Number of participants who experienced neonatal deaths from birth to day 28 was captured for each group. |
| Number of Subjects Experiencing Chorioamnionitis | Time of delivery | The AE of Chorioamnionitis was captured for 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 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
Bioteque cup pessary | 61 |
| No Pessary No pessary will be used. Subjects will receive standard obstetrical management | 61 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Pessary | No Pessary | Total |
|---|---|---|---|
| Age, Customized Maternal Age | 27.7 years | 29.5 years | 28.6 years |
| Region of Enrollment United States | 61 Participants | 61 Participants | 122 Participants |
| Sex: Female, Male Female | 61 Participants | 61 Participants | 122 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 / 61 | 0 / 61 |
| other Total, other adverse events | 3 / 61 | 6 / 61 |
| serious Total, serious adverse events | 0 / 61 | 0 / 61 |
Outcome results
Primary
Number of Subjects Experiencing Preterm Birth
Birth before 37 weeks gestation was captured.
Time frame: Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Number of Subjects Experiencing Preterm Birth | 26 Participants |
| No Pessary | Number of Subjects Experiencing Preterm Birth | 23 Participants |
Secondary
Average Birth Weight of Babies Born on Trial
The birth weights of babies born in the pessary group was compared to those born in the no pessary group
Time frame: Time of delivery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pessary | Average Birth Weight of Babies Born on Trial | 2788 grams |
| No Pessary | Average Birth Weight of Babies Born on Trial | 2843 grams |
Secondary
Number of Participants Experiencing Spontaneous Rupture of Membranes
Rupture of membranes before 34 weeks gestation was captured in each group.
Time frame: Less than 34 weeks gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Number of Participants Experiencing Spontaneous Rupture of Membranes | 18 Participants |
| No Pessary | Number of Participants Experiencing Spontaneous Rupture of Membranes | 10 Participants |
Secondary
Number of Participants That Experienced Spontaneous Preterm Births on Trial
The number of spontaneous births that occurred in participants on trial before 37 weeks was captured.
Time frame: Before 37 weeks gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Number of Participants That Experienced Spontaneous Preterm Births on Trial | 23 Participants |
| No Pessary | Number of Participants That Experienced Spontaneous Preterm Births on Trial | 19 Participants |
Secondary
Number of Subjects Experiencing Chorioamnionitis
The AE of Chorioamnionitis was captured for each group.
Time frame: Time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Number of Subjects Experiencing Chorioamnionitis | 7 Participants |
| No Pessary | Number of Subjects Experiencing Chorioamnionitis | 4 Participants |
Secondary
Number of Subjects Experiencing Neonatal Death
Number of participants who experienced neonatal deaths from birth to day 28 was captured for each group.
Time frame: Between birth and 28 days of age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pessary | Number of Subjects Experiencing Neonatal Death | 3 Participants |
| No Pessary | Number of Subjects Experiencing Neonatal Death | 6 Participants |