Trial Outcomes & Findings for Oral Progesterone for Prevention of Preterm Birth (NCT NCT01180296)

NCT ID: NCT01180296

Last Updated: 2019-02-18

Results Overview

Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 36 participants
• Primary outcome timeframe: Prior to 37 weeks' gestation
• Results posted on: 2019-02-18

Participant Flow

Participant milestones

Measure	Progesterone Group 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery	Placebo Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
Overall Study STARTED	20	16
Overall Study COMPLETED	19	14
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Progesterone Group 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery	Placebo Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
Overall Study Protocol Violation	1	2

Baseline Characteristics

Oral Progesterone for Prevention of Preterm Birth

Baseline characteristics by cohort

Measure	Progesterone Group n=20 Participants 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery	Placebo n=16 Participants Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery	Total n=36 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	20 Participants n=5 Participants	16 Participants n=7 Participants	36 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	29.3 years STANDARD_DEVIATION 4.7 • n=5 Participants	27.2 years STANDARD_DEVIATION 4.9 • n=7 Participants	28 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	16 Participants n=7 Participants	36 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	20 participants n=5 Participants	16 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to 37 weeks' gestation

Spontaneous preterm birth prior to 37 weeks' gestation. Indicated preterm deliveries (for maternal or fetal reasons) were excluded.

Outcome measures

Measure	Progesterone Group n=19 Participants 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery	Placebo n=14 Participants Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
Rate of Recurrent Preterm Birth	5 participants	8 participants

SECONDARY outcome

Timeframe: Mean +/- Std Dev gestational age of 25.9/-2.4 weeks in Progesterone group, and 28.4 +/-4.7 weeks in placebo group

Serum progesterone levels

Outcome measures

Measure	Progesterone Group n=15 Participants 400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery	Placebo n=8 Participants Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
Secondary Outcomes	122.6 pg/mL Standard Deviation 61.8	90.1 pg/mL Standard Deviation 38.7

Adverse Events

Progesterone Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

David McKenna

Fetal Medicine Foundation?USA

Phone: 937-208-4005

Email: dsmckenna@mvh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place