Trial Outcomes & Findings for Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix (NCT NCT02357394)
NCT ID: NCT02357394
Last Updated: 2019-10-31
Results Overview
Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Up to 37 weeks 0 days
Results posted on
2019-10-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
missing data
Baseline characteristics by cohort
| Measure |
Device: Arabin Pessary
n=4 Participants
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.
|
Standard of Care
n=3 Participants
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.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
n=4 Participants
|
36 years
n=3 Participants
|
36.7 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
3 participants
n=3 Participants
|
7 participants
n=7 Participants
|
|
marital status
married or living with partner
|
3 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
|
marital status
never married
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
employment status
full time
|
2 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
|
employment status
unemployed
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
employment status
part-time
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
years education
|
14.5 years
n=4 Participants • missing data
|
14 years
n=1 Participants • missing data
|
14.4 years
n=5 Participants • missing data
|
|
insurance group
private insurance
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=7 Participants
|
|
insurance group
uninsured
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
insurance group
government insurance
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
tobacco use
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
alcohol use
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
prepreg BMI
|
22.4 kg/m^2
n=4 Participants
|
36.4 kg/m^2
n=3 Participants
|
28.4 kg/m^2
n=7 Participants
|
|
infections before enrollment
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
infections at enrollment
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
nullipara
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
# of pregnancies < 16 wk delivered spontaneously
|
0.25 pregnancies
n=4 Participants
|
1 pregnancies
n=3 Participants
|
0.6 pregnancies
n=7 Participants
|
|
# of pregnancies 16w0d-23w6d delivered spontaneously
|
0 pregnancies
n=4 Participants
|
0 pregnancies
n=3 Participants
|
0 pregnancies
n=7 Participants
|
|
# of pregnancies 24w0d-36w6d delivered sponaneously
|
0 pregnancies
n=4 Participants
|
0 pregnancies
n=3 Participants
|
0 pregnancies
n=7 Participants
|
|
prior operative vaginal delivery
yes
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
prior operative vaginal delivery
no
|
3 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
|
prior Cesarean
yes
|
1 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
|
prior Cesarean
no
|
3 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
|
prior cervical surgery
yes
|
0 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
|
prior cervical surgery
no
|
4 Participants
n=4 Participants
|
3 Participants
n=3 Participants
|
7 Participants
n=7 Participants
|
|
gestational weeks at randomization
|
21.4 weeks
n=4 Participants
|
19.6 weeks
n=3 Participants
|
20.7 weeks
n=7 Participants
|
|
TVCL at randomization
|
15.8 millimeters
n=4 Participants
|
20.2 millimeters
n=3 Participants
|
17.7 millimeters
n=7 Participants
|
|
Funneling present
|
4 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
|
sludge present
|
2 Participants
n=4 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
|
progesterone started?
|
0 Participants
n=4 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
|
cerclage placed?
|
0 Participants
n=4 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 37 weeks 0 daysPreterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Preterm Birth Before 37 Weeks
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 34 weeks 0 daysNumber of deliveries before 34 weeks 0 days of gestation
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Preterm Birth Before 34 Weeks
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: antepartum and up to 28 days after postnatal gestational age of 36 weeksCount 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
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Neonatal Composite Morbidity
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of hospital stay, up to 17 weeks after deliveryTotal number of days in hospital after birth
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=3 Participants
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.
|
|---|---|---|
|
Neonatal Length of Stay
|
7 days
Interval 2.0 to 16.0
|
3.3 days
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of hospital stay, up to 17 weeks after deliveryNumber of babies admitted to neonatal intensive care unit after birth during the same hospital stay.
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=3 Participants
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.
|
|---|---|---|
|
Admission to Neonatal Intensive Care Unit
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of hospital stay, up to 17 weeks after deliveryNumber of days a baby spends in the neonatal intensive care unit
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=3 Participants
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.
|
|---|---|---|
|
Total Days in the Neonatal Intensive Care Unit
|
16 days
Interval 16.0 to 16.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of hospital stay, up to 17 weeks after deliveryNumber of days a baby requires use of mechanical ventilation
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=3 Participants
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.
|
|---|---|---|
|
Duration of Ventilator Support
|
0 days
Interval 0.0 to 0.0
|
0 days
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of hospital stay, up to 17 weeks after deliveryNumber of newborn with Retinopathy of Prematurity that requires intervention.
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=3 Participants
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.
|
|---|---|---|
|
Retinopathy of Prematurity Requiring Treatment
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at time of birth, expected to be within 4 weeks of due dateNumber of newborns whose birthweight is less than 1500 grams
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Birthweight < 1500 Grams
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at time of birth, expected to be within 4 weeks of due dateNumber of newborns whose birthweight is less than 2500 grams
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Birthweight < 2500 Grams
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: at time of birth, expected to be within 4 weeks of due dateNumber of weeks of gestation completed by time of delivery
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Gestational Age at Delivery
|
37.3 weeks
Interval 34.0 to 39.4
|
33.1 weeks
Interval 21.1 to 39.0
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of pregnancy, up to nine monthsNumber of participants required use of tocolytic medication
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Use of Tocolysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of pregnancy, up to nine monthsNumber of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Use of Antenatal Steroids
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of pregnancy, up to nine monthsNumber of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Chorioamnionitis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of pregnancy, up to nine monthsNumber of participants who experienced bleeding from lower genital tract during antepartum period
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Vaginal Bleeding
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: participants will be followed for the duration of pregnancy, up to nine monthsNumber of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Preterm Premature Rupture of Membranes
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: at time of delivery, expected to be within 4 weeks of due dateNumber of participants that underwent cesarean delivery
Outcome measures
| Measure |
Standard of Care
n=3 Participants
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.
|
Device: Arabin Pessary
n=4 Participants
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.
|
|---|---|---|
|
Cesarean Delivery
|
0 Participants
|
1 Participants
|
Adverse Events
Device: Arabin Pessary
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gene Lee
University of Kansas Health System, Dept of OBGYN
Phone: 9135886201
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place