Trial Outcomes & Findings for The Use of Progesterone to Reduce Preterm Birth (NCT NCT00830765)

Last Updated: 2013-02-20

Results Overview

Weeks gestation at birth, the interval to delivery, or neonatal morbitity.

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

Through delivery, until discharge up to 40 weeks gestation

Results posted on

2013-02-20

Participant milestones
Measure	1 Placebo The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.	2 Progesterone The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
Overall Study STARTED	73	71
Overall Study COMPLETED	70	69
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal
Measure	1 Placebo The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.	2 Progesterone The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
Overall Study Protocol Violation	3	2

The Use of Progesterone to Reduce Preterm Birth

Baseline characteristics by cohort
Measure	1 Placebo n=73 Participants The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.	2 Progesterone n=71 Participants The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.	Total n=144 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=5 Participants	71 Participants n=7 Participants	144 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	25.4 years STANDARD_DEVIATION 5.0 • n=5 Participants	23.3 years STANDARD_DEVIATION 5.8 • n=7 Participants	24.4 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants	71 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	73 participants n=5 Participants	71 participants n=7 Participants	144 participants n=5 Participants

Timeframe: Through delivery, until discharge up to 40 weeks gestation

Population: Intention to treat analysis in both groups

Weeks gestation at birth, the interval to delivery, or neonatal morbitity.

Outcome measures
Measure	Progesterone Group n=71 Participants Progesterone injection was compared to placebo injection on a weekly basis.	Placebo Group n=73 Participants Progesterone injection was compared to placebo injection on a weekly basis.
Weeks Gestation at Birth Among Patients Receiving the Active Drug.	31.9 weeks Standard Deviation 3.5	30.2 weeks Standard Deviation 3.1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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