Trial Outcomes & Findings for Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) (NCT NCT01119963)
NCT ID: NCT01119963
Last Updated: 2018-06-28
Results Overview
Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
152 participants
Primary outcome timeframe
Measured from day of last menstrual cycle to day of birth and measured in weeks.
Results posted on
2018-06-28
Participant Flow
Participants between the Gestational age of 23w0d-30w6d were approach in the hospital setting following confirmation of rupture of membranes.
We had two patient that consented to the study but were withdrawn prior to randomization because they began to go into labor
Participant milestones
| Measure |
17-alpha Hydroxyprogesterone Caproate, Makena®
250 mg of 17P, Makena® intramuscular (IM) weekly.
17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
Placebo
Castor Oil (Placebo)intramuscular (IM) weekly
Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
78
|
|
Overall Study
COMPLETED
|
73
|
77
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
17-alpha Hydroxyprogesterone Caproate, Makena®
250 mg of 17P, Makena® intramuscular (IM) weekly.
17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
Placebo
Castor Oil (Placebo)intramuscular (IM) weekly
Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
Baseline characteristics by cohort
| Measure |
17-alpha Hydroxyprogesterone Caproate, Makena®
n=74 Participants
250 mg of 17P, Makena® intramuscular (IM) weekly.
17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
Placebo
n=78 Participants
Castor Oil (Placebo)intramuscular (IM) weekly
Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 5.8 • n=74 Participants
|
29.5 years
STANDARD_DEVIATION 5.7 • n=78 Participants
|
29.7 years
STANDARD_DEVIATION 5.8 • n=152 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=74 Participants
|
78 Participants
n=78 Participants
|
152 Participants
n=152 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=74 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=152 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=74 Participants
|
16 Participants
n=78 Participants
|
37 Participants
n=152 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=74 Participants
|
61 Participants
n=78 Participants
|
114 Participants
n=152 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=74 Participants
|
1 Participants
n=78 Participants
|
1 Participants
n=152 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=53 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
4 Participants
n=62 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
7 Participants
n=115 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=53 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
1 Participants
n=62 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
5 Participants
n=115 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=53 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
0 Participants
n=62 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
1 Participants
n=115 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=53 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
14 Participants
n=62 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
22 Participants
n=115 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
|
Race (NIH/OMB)
White
|
37 Participants
n=53 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
42 Participants
n=62 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
79 Participants
n=115 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=53 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
1 Participants
n=62 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
1 Participants
n=115 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=53 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
0 Participants
n=62 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
0 Participants
n=115 Participants • this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
|
|
Region of Enrollment
United States
|
74 Participants
n=74 Participants
|
78 Participants
n=78 Participants
|
152 Participants
n=152 Participants
|
|
Marital Status
Married/Living with partner
|
44 Participants
n=74 Participants
|
46 Participants
n=78 Participants
|
90 Participants
n=152 Participants
|
|
Marital Status
Single/Widowed
|
27 Participants
n=74 Participants
|
30 Participants
n=78 Participants
|
57 Participants
n=152 Participants
|
|
Marital Status
Divorced/Separated
|
3 Participants
n=74 Participants
|
0 Participants
n=78 Participants
|
3 Participants
n=152 Participants
|
|
Marital Status
Other (Unknown)
|
0 Participants
n=74 Participants
|
2 Participants
n=78 Participants
|
2 Participants
n=152 Participants
|
|
Education
< HS graduate
|
6 Participants
n=74 Participants
|
10 Participants
n=78 Participants
|
16 Participants
n=152 Participants
|
|
Education
HS Graduate or equivalent
|
11 Participants
n=74 Participants
|
18 Participants
n=78 Participants
|
29 Participants
n=152 Participants
|
|
Education
Some College
|
22 Participants
n=74 Participants
|
15 Participants
n=78 Participants
|
37 Participants
n=152 Participants
|
|
Education
College Graduate
|
17 Participants
n=74 Participants
|
15 Participants
n=78 Participants
|
32 Participants
n=152 Participants
|
|
Education
Not Reported
|
18 Participants
n=74 Participants
|
20 Participants
n=78 Participants
|
38 Participants
n=152 Participants
|
|
Tobacco Use
|
4 Participants
n=74 Participants
|
5 Participants
n=78 Participants
|
9 Participants
n=152 Participants
|
|
Illicit Drug Use
|
7 Participants
n=74 Participants
|
14 Participants
n=78 Participants
|
21 Participants
n=152 Participants
|
|
Gestational Age at Membrane Rupture
|
25.9 weeks
STANDARD_DEVIATION 3.0 • n=74 Participants
|
26.6 weeks
STANDARD_DEVIATION 2.9 • n=78 Participants
|
26.2 weeks
STANDARD_DEVIATION 3.0 • n=152 Participants
|
|
Gestational Age at time of randomization (wks)
|
26.7 weeks
STANDARD_DEVIATION 2.5 • n=74 Participants
|
27.1 weeks
STANDARD_DEVIATION 2.4 • n=78 Participants
|
26.9 weeks
STANDARD_DEVIATION 2.5 • n=152 Participants
|
|
Gestational Age Stratum at randomization (wks)
23w0d-25w6d
|
31 Participants
n=74 Participants
|
28 Participants
n=78 Participants
|
59 Participants
n=152 Participants
|
|
Gestational Age Stratum at randomization (wks)
26w0d - 28w6d
|
24 Participants
n=74 Participants
|
27 Participants
n=78 Participants
|
51 Participants
n=152 Participants
|
|
Gestational Age Stratum at randomization (wks)
29w0d-30w6d
|
19 Participants
n=74 Participants
|
23 Participants
n=78 Participants
|
42 Participants
n=152 Participants
|
PRIMARY outcome
Timeframe: Measured from day of last menstrual cycle to day of birth and measured in weeks.Population: Intent to treat population (included all participants who were randomized, whether they received study medication or not).
Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.
Outcome measures
| Measure |
17-alpha Hydroxyprogesterone Caproate, Makena®
n=73 Participants
250 mg of 17P, Makena® intramuscular (IM) weekly.
17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
Placebo
n=77 Participants
Castor Oil (Placebo)intramuscular (IM) weekly
Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
|---|---|---|
|
Gestational Age at Delivery
|
29.2 weeks.
Standard Deviation 2.72
|
29.5 weeks.
Standard Deviation 2.74
|
SECONDARY outcome
Timeframe: average number of days measured from day of study entry until day of deliveryPopulation: Intent to treat population (included all participants who were randomized, whether they received study medication or not).
Secondary Outcomes: \- Duration of latency period (time from randomization to birth)
Outcome measures
| Measure |
17-alpha Hydroxyprogesterone Caproate, Makena®
n=73 Participants
250 mg of 17P, Makena® intramuscular (IM) weekly.
17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
Placebo
n=77 Participants
Castor Oil (Placebo)intramuscular (IM) weekly
Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
|---|---|---|
|
Duration of Latency Period
|
17.1 days
Standard Deviation 16.08
|
17.0 days
Standard Deviation 15.77
|
Adverse Events
Neonate: 17-alpha Hydroxyprogesterone Caproate, Makena®
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Neonate: Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
17-alpha Hydroxyprogesterone Caproate, Makena®
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
| Measure |
Neonate: 17-alpha Hydroxyprogesterone Caproate, Makena®
n=73 participants at risk
Neonate:
250 mg of 17P, Makena® intramuscular (IM) weekly.
17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
Neonate: Placebo
n=77 participants at risk
Neonate:
Castor Oil (Placebo)intramuscular (IM) weekly
Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
17-alpha Hydroxyprogesterone Caproate, Makena®
n=73 participants at risk
250 mg of 17P, Makena® intramuscular (IM) weekly.
17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
Placebo
n=77 participants at risk
Castor Oil (Placebo)intramuscular (IM) weekly
Castor Oil (Placebo): IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Congenital Diaphragmatic Hernia
|
1.4%
1/73 • Number of events 1 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/77 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/73 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/77 • Up to 60 days post delivery or discharge which ever comes first
|
|
Infections and infestations
Respiratory Failure, Sepsis
|
1.4%
1/73 • Number of events 1 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/77 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/73 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/77 • Up to 60 days post delivery or discharge which ever comes first
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
1.4%
1/73 • Number of events 1 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/77 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/73 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/77 • Up to 60 days post delivery or discharge which ever comes first
|
|
Respiratory, thoracic and mediastinal disorders
Atypical Pulmonary Infection
|
0.00%
0/73 • Up to 60 days post delivery or discharge which ever comes first
|
1.3%
1/77 • Number of events 1 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/73 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/77 • Up to 60 days post delivery or discharge which ever comes first
|
|
Cardiac disorders
Suspected Pulmonary Hypertension
|
0.00%
0/73 • Up to 60 days post delivery or discharge which ever comes first
|
1.3%
1/77 • Number of events 1 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/73 • Up to 60 days post delivery or discharge which ever comes first
|
0.00%
0/77 • Up to 60 days post delivery or discharge which ever comes first
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place