Premature Birth
Conditions
Keywords
arabin pessary, short cervix
Brief summary
The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.
Detailed description
This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.
Interventions
DEVICEArabin Pessary
Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team.
Sponsors
Medical University of South Carolina
Gene Lee, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* singleton * cervical length \< 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days * agrees to refrain from sexual intercourse
Exclusion criteria
* major fetal anomalies * painful regular uterine contractions * active vaginal bleeding * ruptured membranes * evidence of chorioamnionitis or other maternal/fetal infectious morbidity * placenta previa * cervical cerclage in situ * visual cervical dilation of 2 cm or greater with visible amnion/chorion * significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm Birth Before 37 Weeks | Up to 37 weeks 0 days | Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Composite Morbidity | antepartum and up to 28 days after postnatal gestational age of 36 weeks | Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis |
| Neonatal Length of Stay | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | Total number of days in hospital after birth |
| Admission to Neonatal Intensive Care Unit | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay. |
| Total Days in the Neonatal Intensive Care Unit | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | Number of days a baby spends in the neonatal intensive care unit |
| Duration of Ventilator Support | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | Number of days a baby requires use of mechanical ventilation |
| Retinopathy of Prematurity Requiring Treatment | participants will be followed for the duration of hospital stay, up to 17 weeks after delivery | Number of newborn with Retinopathy of Prematurity that requires intervention. |
| Birthweight < 1500 Grams | at time of birth, expected to be within 4 weeks of due date | Number of newborns whose birthweight is less than 1500 grams |
| Preterm Birth Before 34 Weeks | up to 34 weeks 0 days | Number of deliveries before 34 weeks 0 days of gestation |
| Gestational Age at Delivery | at time of birth, expected to be within 4 weeks of due date | Number of weeks of gestation completed by time of delivery |
| Use of Tocolysis | participants will be followed for the duration of pregnancy, up to nine months | Number of participants required use of tocolytic medication |
| Use of Antenatal Steroids | participants will be followed for the duration of pregnancy, up to nine months | Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery |
| Chorioamnionitis | participants will be followed for the duration of pregnancy, up to nine months | Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia. |
| Vaginal Bleeding | participants will be followed for the duration of pregnancy, up to nine months | Number of participants who experienced bleeding from lower genital tract during antepartum period |
| Preterm Premature Rupture of Membranes | participants will be followed for the duration of pregnancy, up to nine months | Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test. |
| Cesarean Delivery | at time of delivery, expected to be within 4 weeks of due date | Number of participants that underwent cesarean delivery |
| Birthweight < 2500 Grams | at time of birth, expected to be within 4 weeks of due date | Number of newborns whose birthweight is less than 2500 grams |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device: Arabin Pessary Participants randomized to this group will receive the pessary.
Arabin Pessary: Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team. | 4 |
| Standard of Care Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Device: Arabin Pessary | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 37.2 years | 36 years | 36.7 years |
| alcohol use | 0 Participants | 0 Participants | 0 Participants |
| cerclage placed? | 0 Participants | 1 Participants | 1 Participants |
| employment status full time | 2 Participants | 3 Participants | 5 Participants |
| employment status part-time | 1 Participants | 0 Participants | 1 Participants |
| employment status unemployed | 1 Participants | 0 Participants | 1 Participants |
| Funneling present | 4 Participants | 2 Participants | 6 Participants |
| gestational weeks at randomization | 21.4 weeks | 19.6 weeks | 20.7 weeks |
| infections at enrollment | 1 Participants | 0 Participants | 1 Participants |
| infections before enrollment | 0 Participants | 0 Participants | 0 Participants |
| insurance group government insurance | 0 Participants | 0 Participants | 0 Participants |
| insurance group private insurance | 4 Participants | 3 Participants | 7 Participants |
| insurance group uninsured | 0 Participants | 0 Participants | 0 Participants |
| marital status married or living with partner | 3 Participants | 3 Participants | 6 Participants |
| marital status never married | 1 Participants | 0 Participants | 1 Participants |
| nullipara | 0 Participants | 1 Participants | 1 Participants |
| # of pregnancies 16w0d-23w6d delivered spontaneously | 0 pregnancies | 0 pregnancies | 0 pregnancies |
| # of pregnancies < 16 wk delivered spontaneously | 0.25 pregnancies | 1 pregnancies | 0.6 pregnancies |
| # of pregnancies 24w0d-36w6d delivered sponaneously | 0 pregnancies | 0 pregnancies | 0 pregnancies |
| prepreg BMI | 22.4 kg/m^2 | 36.4 kg/m^2 | 28.4 kg/m^2 |
| prior cervical surgery no | 4 Participants | 3 Participants | 7 Participants |
| prior cervical surgery yes | 0 Participants | 0 Participants | 0 Participants |
| prior Cesarean no | 3 Participants | 3 Participants | 6 Participants |
| prior Cesarean yes | 1 Participants | 0 Participants | 1 Participants |
| prior operative vaginal delivery no | 3 Participants | 3 Participants | 6 Participants |
| prior operative vaginal delivery yes | 1 Participants | 0 Participants | 1 Participants |
| progesterone started? | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 4 participants | 3 participants | 7 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| sludge present | 2 Participants | 0 Participants | 2 Participants |
| tobacco use | 1 Participants | 0 Participants | 1 Participants |
| TVCL at randomization | 15.8 millimeters | 20.2 millimeters | 17.7 millimeters |
| years education | 14.5 years | 14 years | 14.4 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
Preterm Birth Before 37 Weeks
Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
Time frame: Up to 37 weeks 0 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Preterm Birth Before 37 Weeks | 3 Participants |
| Standard of Care | Preterm Birth Before 37 Weeks | 1 Participants |
Secondary
Admission to Neonatal Intensive Care Unit
Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay.
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Admission to Neonatal Intensive Care Unit | 0 Participants |
| Standard of Care | Admission to Neonatal Intensive Care Unit | 1 Participants |
Secondary
Birthweight < 1500 Grams
Number of newborns whose birthweight is less than 1500 grams
Time frame: at time of birth, expected to be within 4 weeks of due date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Birthweight < 1500 Grams | 1 Participants |
| Standard of Care | Birthweight < 1500 Grams | 0 Participants |
Secondary
Birthweight < 2500 Grams
Number of newborns whose birthweight is less than 2500 grams
Time frame: at time of birth, expected to be within 4 weeks of due date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Birthweight < 2500 Grams | 3 Participants |
| Standard of Care | Birthweight < 2500 Grams | 1 Participants |
Secondary
Cesarean Delivery
Number of participants that underwent cesarean delivery
Time frame: at time of delivery, expected to be within 4 weeks of due date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Cesarean Delivery | 1 Participants |
| Standard of Care | Cesarean Delivery | 0 Participants |
Secondary
Chorioamnionitis
Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Time frame: participants will be followed for the duration of pregnancy, up to nine months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Chorioamnionitis | 0 Participants |
| Standard of Care | Chorioamnionitis | 0 Participants |
Secondary
Duration of Ventilator Support
Number of days a baby requires use of mechanical ventilation
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Device: Arabin Pessary | Duration of Ventilator Support | 0 days |
| Standard of Care | Duration of Ventilator Support | 0 days |
Secondary
Gestational Age at Delivery
Number of weeks of gestation completed by time of delivery
Time frame: at time of birth, expected to be within 4 weeks of due date
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Device: Arabin Pessary | Gestational Age at Delivery | 33.1 weeks |
| Standard of Care | Gestational Age at Delivery | 37.3 weeks |
Secondary
Neonatal Composite Morbidity
Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis
Time frame: antepartum and up to 28 days after postnatal gestational age of 36 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Neonatal Composite Morbidity | 1 Participants |
| Standard of Care | Neonatal Composite Morbidity | 0 Participants |
Secondary
Neonatal Length of Stay
Total number of days in hospital after birth
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Device: Arabin Pessary | Neonatal Length of Stay | 3.3 days |
| Standard of Care | Neonatal Length of Stay | 7 days |
Secondary
Preterm Birth Before 34 Weeks
Number of deliveries before 34 weeks 0 days of gestation
Time frame: up to 34 weeks 0 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Preterm Birth Before 34 Weeks | 1 Participants |
| Standard of Care | Preterm Birth Before 34 Weeks | 0 Participants |
Secondary
Preterm Premature Rupture of Membranes
Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Time frame: participants will be followed for the duration of pregnancy, up to nine months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Preterm Premature Rupture of Membranes | 1 Participants |
| Standard of Care | Preterm Premature Rupture of Membranes | 1 Participants |
Secondary
Retinopathy of Prematurity Requiring Treatment
Number of newborn with Retinopathy of Prematurity that requires intervention.
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Retinopathy of Prematurity Requiring Treatment | 0 Participants |
| Standard of Care | Retinopathy of Prematurity Requiring Treatment | 0 Participants |
Secondary
Total Days in the Neonatal Intensive Care Unit
Number of days a baby spends in the neonatal intensive care unit
Time frame: participants will be followed for the duration of hospital stay, up to 17 weeks after delivery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Device: Arabin Pessary | Total Days in the Neonatal Intensive Care Unit | 0 days |
| Standard of Care | Total Days in the Neonatal Intensive Care Unit | 16 days |
Secondary
Use of Antenatal Steroids
Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery
Time frame: participants will be followed for the duration of pregnancy, up to nine months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Use of Antenatal Steroids | 0 Participants |
| Standard of Care | Use of Antenatal Steroids | 3 Participants |
Secondary
Use of Tocolysis
Number of participants required use of tocolytic medication
Time frame: participants will be followed for the duration of pregnancy, up to nine months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Use of Tocolysis | 0 Participants |
| Standard of Care | Use of Tocolysis | 0 Participants |
Secondary
Vaginal Bleeding
Number of participants who experienced bleeding from lower genital tract during antepartum period
Time frame: participants will be followed for the duration of pregnancy, up to nine months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Arabin Pessary | Vaginal Bleeding | 1 Participants |
| Standard of Care | Vaginal Bleeding | 0 Participants |