Trial Outcomes & Findings for Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial. (NCT NCT01050647)

NCT ID: NCT01050647

Last Updated: 2019-04-09

Results Overview

Delayed delivery until 34 weeks gestation.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: From enrollment until delivery, an average of 34 weeks
• Results posted on: 2019-04-09

Participant Flow

Participant milestones

Measure	17-hydroxyprogesterone Caproate Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.	Castor Oil Injections Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Overall Study STARTED	10	11
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

Baseline characteristics by cohort

Measure	17-hydroxyprogesterone Caproate n=10 Participants Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.	Castor Oil Injections n=11 Participants Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.	Total n=21 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 1.9 • n=5 Participants	31.7 years STANDARD_DEVIATION 2.0 • n=7 Participants	31.7 years STANDARD_DEVIATION 1.95 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 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	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	1 Participants n=5 Participants	0 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 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	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
History of prior preterm birth	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment until delivery, an average of 34 weeks

Delayed delivery until 34 weeks gestation.

Outcome measures

Measure	17-hydroxyprogesterone Caproate n=10 Participants Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.	Castor Oil Injections n=11 Participants Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Number of Participants With Achievement of 34 Weeks Gestation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From delivery until neonatal hospital discharge, assessed up to 2 months

Outcome measures

Measure	17-hydroxyprogesterone Caproate n=10 Participants Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.	Castor Oil Injections n=11 Participants Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Number of Participants With Neonatal Respiratory Distress Syndrome	7 Participants	10 Participants

SECONDARY outcome

Timeframe: From delivery until neonatal hospital discharge, assessed up to 2 months

Outcome measures

Measure	17-hydroxyprogesterone Caproate n=10 Participants Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.	Castor Oil Injections n=11 Participants Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From delivery to neonatal discharge, assessed up to 2 months

Outcome measures

Measure	17-hydroxyprogesterone Caproate n=10 Participants Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.	Castor Oil Injections n=11 Participants Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Number of Participants With Neonatal Necrotizing Enterocolitis	2 Participants	1 Participants

SECONDARY outcome

Timeframe: From birth to discharge form delivery hospital, assessed up to 2 months

Outcome measures

Measure	17-hydroxyprogesterone Caproate n=10 Participants Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.	Castor Oil Injections n=11 Participants Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days	39 days Interval 13.0 to 59.0	50 days Interval 34.0 to 69.0

SECONDARY outcome

Timeframe: From rupture of membranes until delivery, assessed up to 34 weeks of gestation

Outcome measures

Measure	17-hydroxyprogesterone Caproate n=10 Participants Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation 17-Hydroxyprogesterone Caproate: Weekly injections of 17-hydroxyprogesterone caproate.	Castor Oil Injections n=11 Participants Weekly injections of Caster Oil (placebo) Caster Oil injections: Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.
Length of Latency Assessed as Number of Days	14.5 days Interval 8.9 to 29.1	8 days Interval 5.3 to 13.4

Adverse Events

17-hydroxyprogesterone Caproate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Castor Oil Injections

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

Dr. Anna Girsen

Stanford University

Phone: 6507255720

Email: agirsen@stanford.edu

Results disclosure agreements

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