Trial Outcomes & Findings for Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial (NCT NCT00946088)
NCT ID: NCT00946088
Last Updated: 2017-03-16
Results Overview
Reduction in delivery rate prior to 37 weeks gestation (preterm birth).
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
7 participants
Primary outcome timeframe
Up to 37 weeks of gestation
Results posted on
2017-03-16
Participant Flow
Patients were enrolled from November 2010 through February 2011.
Participant milestones
| Measure |
Progesterone
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol 400 Distearate & Hydrogenated Vegetable oi
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Progesterone
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol 400 Distearate & Hydrogenated Vegetable oi
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Progesterone for Maintenance Tocolysis: A Randomized Placebo Controlled Trial
Baseline characteristics by cohort
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol & Hydrogenated Vegetable Oil
n=3 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.5 years
n=5 Participants
|
27.0 years
n=7 Participants
|
27.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 37 weeks of gestationReduction in delivery rate prior to 37 weeks gestation (preterm birth).
Outcome measures
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol&Hydrogenated Vegetable Oil
n=2 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina
|
|---|---|---|
|
Reduction in Delivery Rate Prior to 37 Weeks Gestation
Delivery at >=37 weeks of gestation
|
2 Participants
|
2 Participants
|
|
Reduction in Delivery Rate Prior to 37 Weeks Gestation
Delivery at <37 weeks of gestation
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to maternal hospital dischargeOutcome measures
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol&Hydrogenated Vegetable Oil
n=2 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina
|
|---|---|---|
|
Maternal Chorioamnionitis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to the maternal discharge from delivery hospitalizationOutcome measures
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol&Hydrogenated Vegetable Oil
n=2 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina
|
|---|---|---|
|
Maternal Anticipated Adverse Medication Reaction
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the time of newborn birthNewborn birthweight in grams
Outcome measures
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol&Hydrogenated Vegetable Oil
n=2 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina
|
|---|---|---|
|
Birthweight
|
2740 grams
Interval 1390.0 to 3720.0
|
3275 grams
Interval 3070.0 to 3380.0
|
SECONDARY outcome
Timeframe: At time of neonatal dischargeOutcome measures
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol&Hydrogenated Vegetable Oil
n=2 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina
|
|---|---|---|
|
Neonatal Intensive Care Unit (NICU) Admission
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after neonatal birthOutcome measures
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol&Hydrogenated Vegetable Oil
n=2 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina
|
|---|---|---|
|
Neonatal Morbidity
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after neonatal birthOutcome measures
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol&Hydrogenated Vegetable Oil
n=2 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina
|
|---|---|---|
|
Neonatal Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to the time of neonatal discharge from the delivery hospitalOutcome measures
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol&Hydrogenated Vegetable Oil
n=3 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina
|
|---|---|---|
|
Neonatal Congenital Abnormalities
|
0 Neonates
|
0 Neonates
|
SECONDARY outcome
Timeframe: Up to the time of deliveryPopulation: exact delivery data unavailable for one term participant
Number of days from intervention to delivery
Outcome measures
| Measure |
Progesterone
n=4 Participants
Progesterone 400 mg per vagina qhs.
|
Polyethylene Glycol&Hydrogenated Vegetable Oil
n=2 Participants
Polyethylene glycol 400 distearate \& hydrogenated vegetable oil per vagina
|
|---|---|---|
|
Number of Days Delay of Delivery
|
38.0 days
Interval 6.0 to 62.0
|
47.5 days
Interval 43.0 to 52.0
|
Adverse Events
Active Comparator: Progesterone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab
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
Deirdre Lyell, MD
Stanford University School of Medicine
Phone: (650) 384-5107
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place