Trial Outcomes & Findings for Comparing IM vs. Vaginal Progesterone for Pre-term Birth (NCT NCT00579553)

NCT ID: NCT00579553

Last Updated: 2021-05-19

Results Overview

Delivery before 37 weeks gestation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 174 participants
• Primary outcome timeframe: From 16-20 weeks gestation through preterm delivery
• Results posted on: 2021-05-19

Participant Flow

Participant milestones

Measure	Intramuscular Progesterone Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P	Vaginal Progesterone Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily
Overall Study STARTED	82	92
Overall Study COMPLETED	66	79
Overall Study NOT COMPLETED	16	13

Reasons for withdrawal

Measure	Intramuscular Progesterone Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P	Vaginal Progesterone Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily
Overall Study Lost to Follow-up	16	13

Baseline Characteristics

Comparing IM vs. Vaginal Progesterone for Pre-term Birth

Baseline characteristics by cohort

Measure	Intramuscular Progesterone n=66 Participants Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P	Vaginal Progesterone n=79 Participants Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily	Total n=145 Participants Total of all reporting groups
Age, Continuous	25.6 years STANDARD_DEVIATION 4.3 • n=5 Participants	26.8 years STANDARD_DEVIATION 4.7 • n=7 Participants	26.3 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	79 Participants n=7 Participants	145 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	66 participants n=5 Participants	79 participants n=7 Participants	145 participants n=5 Participants
Educational Level College	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Educational Level High School	38 Participants n=5 Participants	44 Participants n=7 Participants	82 Participants n=5 Participants
Educational Level Less than high school	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Tobacco use Tobacco use	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Tobacco use No tobacco use	55 Participants n=5 Participants	63 Participants n=7 Participants	118 Participants n=5 Participants

PRIMARY outcome

Timeframe: From 16-20 weeks gestation through preterm delivery

Delivery before 37 weeks gestation.

Outcome measures

Measure	Intramuscular Progesterone n=66 Participants Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P	Vaginal Progesterone n=79 Participants Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily
Preterm Birth	29 Participants	30 Participants

SECONDARY outcome

Timeframe: From 16-20 weeks gestation through preterm delivery

Delivery below 34 weeks gestation

Outcome measures

Measure	Intramuscular Progesterone n=66 Participants Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P	Vaginal Progesterone n=79 Participants Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily
Preterm Birth Delivery less than 34 weeks	13 Participants	14 Participants
Preterm Birth Delivery less than 28 weeks	7 Participants	8 Participants

SECONDARY outcome

Timeframe: From 16-20 weeks gestation through preterm delivery

Mean gestational age at delivery

Outcome measures

Measure	Intramuscular Progesterone n=66 Participants Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P	Vaginal Progesterone n=79 Participants Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily
Gestational Age at Delivery	35.8 Weeks gestation Standard Deviation 4.7	36.3 Weeks gestation Standard Deviation 5.7

SECONDARY outcome

Timeframe: At delivery

Outcome measures

Measure	Intramuscular Progesterone n=66 Participants Intramuscular Progesterone Intramuscular Progesterone: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P	Vaginal Progesterone n=79 Participants Vaginal Progesterone Vaginal Progesterone: Vaginal Progesterone: 100 mg vaginal suppository daily
Mean Neonatal Birth Weight	2680.6 grams Standard Deviation 840	2771.6 grams Standard Deviation 1131

Adverse Events

Intramuscular Progesterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vaginal Progesterone

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

Andrew Elimian, MD

University of Oklahoma Health Science Center

Phone: 19146465194

Email: aelimian@aol.com

Results disclosure agreements

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