Trial Outcomes & Findings for Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor (NCT NCT01840228)
NCT ID: NCT01840228
Last Updated: 2019-06-18
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Duration of current pregnancy, anticipated maximum 18 weeks
Results posted on
2019-06-18
Participant Flow
Participant milestones
| Measure |
Micronized Progesterone Suppository
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Micronized Progesterone Suppository
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor
Baseline characteristics by cohort
| Measure |
Micronized Progesterone Suppository
n=19 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=19 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.8 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
26.0 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Parity
|
1 births
n=5 Participants
|
1 births
n=7 Participants
|
1 births
n=5 Participants
|
|
Body mass index
|
25.3 kg/m2
STANDARD_DEVIATION 7.9 • n=5 Participants
|
25.4 kg/m2
STANDARD_DEVIATION 8.3 • n=7 Participants
|
25.3 kg/m2
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Prior preterm birth
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Twin gestation
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Marital status
Single
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Marital status
Married
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Marital status
Divorced
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital status
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Insurance use
Public insurance
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Insurance use
Private insurance
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Insurance use
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Gestational age at enrollment
|
30.6 weeks
n=5 Participants
|
30.4 weeks
n=7 Participants
|
30.5 weeks
n=5 Participants
|
|
Cervical dilation at admission
|
1.5 cm
n=5 Participants
|
1 cm
n=7 Participants
|
1.25 cm
n=5 Participants
|
|
Cervical dilation at enrollment
|
3 cm
n=5 Participants
|
2.5 cm
n=7 Participants
|
2.75 cm
n=5 Participants
|
|
Tobacco use
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Prior use of progesterone (17OHP-C)
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of current pregnancy, anticipated maximum 18 weeksOutcome measures
| Measure |
Micronized Progesterone Suppository
n=18 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=18 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Micronized Progesterone Suppository - TWINS
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.
Micronized progesterone suppository
|
Placebo Suppository - TWINS
One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup
Micronized progesterone suppository
|
|---|---|---|---|---|
|
Number of Participants Who Delivered Before 37 Weeks'
|
11 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Duration of current pregnancy, anticipated maximum 18 weeksEvaluated in women enrolled prior to 32 weeks gestation
Outcome measures
| Measure |
Micronized Progesterone Suppository
n=14 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=12 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Micronized Progesterone Suppository - TWINS
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.
Micronized progesterone suppository
|
Placebo Suppository - TWINS
One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup
Micronized progesterone suppository
|
|---|---|---|---|---|
|
Number of Participants Who Delivered Before 34 Weeks'
|
3 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 weeksOutcome measures
| Measure |
Micronized Progesterone Suppository
n=18 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=18 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Micronized Progesterone Suppository - TWINS
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.
Micronized progesterone suppository
|
Placebo Suppository - TWINS
One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup
Micronized progesterone suppository
|
|---|---|---|---|---|
|
Delivery Within 2 Weeks of Randomization
|
6 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Duration of current pregnancy, anticipated maximum 18 weeksOutcome measures
| Measure |
Micronized Progesterone Suppository
n=18 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=18 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Micronized Progesterone Suppository - TWINS
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.
Micronized progesterone suppository
|
Placebo Suppository - TWINS
One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup
Micronized progesterone suppository
|
|---|---|---|---|---|
|
Number of Weeks Pregnancy Prolongation
|
5.3 weeks
Interval 1.3 to 6.7
|
5.0 weeks
Interval 2.0 to 8.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day of delivery in current pregnancyOutcome measures
| Measure |
Micronized Progesterone Suppository
n=14 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=14 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Micronized Progesterone Suppository - TWINS
n=8 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.
Micronized progesterone suppository
|
Placebo Suppository - TWINS
n=8 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup
Micronized progesterone suppository
|
|---|---|---|---|---|
|
Infant Birth Weight
|
2454.9 grams
Standard Deviation 659.4
|
2523.1 grams
Standard Deviation 748.5
|
2164.4 grams
Standard Deviation 215.9
|
1974.1 grams
Standard Deviation 252.8
|
SECONDARY outcome
Timeframe: Followed for duration of neonatal hospital stay, estimated maximum 16 weeksOutcome measures
| Measure |
Micronized Progesterone Suppository
n=14 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=14 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Micronized Progesterone Suppository - TWINS
n=8 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.
Micronized progesterone suppository
|
Placebo Suppository - TWINS
n=8 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup
Micronized progesterone suppository
|
|---|---|---|---|---|
|
Neonatal Intensive Care Unit Admission
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Duration of current pregnancy, anticipated maximum 18 weeksOutcome measures
| Measure |
Micronized Progesterone Suppository
n=18 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=18 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Micronized Progesterone Suppository - TWINS
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.
Micronized progesterone suppository
|
Placebo Suppository - TWINS
One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup
Micronized progesterone suppository
|
|---|---|---|---|---|
|
Number of Participants With Chorioamnionitis
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Followed for duration of neonatal hospital stay, estimated maximum 16 weeksA composite neonatal outcome comprising neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, severe (grade III/IV) interventricular hemorrhage, necrotizing enterocolitis, and sepsis.
Outcome measures
| Measure |
Micronized Progesterone Suppository
n=14 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=14 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Micronized Progesterone Suppository - TWINS
n=8 Participants
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation in twin subgroup.
Micronized progesterone suppository
|
Placebo Suppository - TWINS
n=8 Participants
One placebo suppository vaginally daily until 36 6/7 weeks' gestation in twin subgroup
Micronized progesterone suppository
|
|---|---|---|---|---|
|
Composite Neonatal Outcome
|
5 Participants
|
5 Participants
|
3 Participants
|
7 Participants
|
Adverse Events
Micronized Progesterone Suppository
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Suppository
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Micronized Progesterone Suppository
n=18 participants at risk
Micronized progesterone suppository 200 mg vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
Placebo Suppository
n=18 participants at risk
One placebo suppository vaginally daily until 36 6/7 weeks' gestation.
Micronized progesterone suppository
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal discharge
|
16.7%
3/18 • Number of events 3 • Information about adverse events was collected from time of enrollment until discharge from the hospital after delivery for all participants, which is generally < 1 week after delivery
|
27.8%
5/18 • Number of events 5 • Information about adverse events was collected from time of enrollment until discharge from the hospital after delivery for all participants, which is generally < 1 week after delivery
|
|
Reproductive system and breast disorders
Vaginal irritation
|
16.7%
3/18 • Number of events 3 • Information about adverse events was collected from time of enrollment until discharge from the hospital after delivery for all participants, which is generally < 1 week after delivery
|
0.00%
0/18 • Information about adverse events was collected from time of enrollment until discharge from the hospital after delivery for all participants, which is generally < 1 week after delivery
|
|
General disorders
Other
|
0.00%
0/18 • Information about adverse events was collected from time of enrollment until discharge from the hospital after delivery for all participants, which is generally < 1 week after delivery
|
16.7%
3/18 • Number of events 3 • Information about adverse events was collected from time of enrollment until discharge from the hospital after delivery for all participants, which is generally < 1 week after delivery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place