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Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) (17PinPROM)

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ClinicalTrials.gov Identifier: NCT01119963
Recruitment Status : Completed
First Posted : May 10, 2010
Results First Posted : May 30, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety ( Obstetrix Medical Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Preterm Delivery
Interventions Drug: 17-alpha-hydroxy-progesterone caproate, Makena®
Drug: Castor Oil (Placebo)
Enrollment 152
Recruitment Details Participants between the Gestational age of 23w0d-30w6d were approach in the hospital setting following confirmation of rupture of membranes.
Pre-assignment Details We had two patient that consented to the study but were withdrawn prior to randomization because they began to go into labor
Arm/Group Title 17-alpha Hydroxyprogesterone Caproate, Makena® Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 74 78
Completed 73 77
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title 17-alpha Hydroxyprogesterone Caproate, Makena® Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 74 78 152
Hide Baseline Analysis Population Description
Age, Continuous
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 78 participants 152 participants
29.9  (5.8) 29.5  (5.7) 29.7  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 78 participants 152 participants
Female
74
 100.0%
78
 100.0%
152
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 78 participants 152 participants
Hispanic or Latino
21
  28.4%
16
  20.5%
37
  24.3%
Not Hispanic or Latino
53
  71.6%
61
  78.2%
114
  75.0%
Unknown or Not Reported
0
   0.0%
1
   1.3%
1
   0.7%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 62 participants 115 participants
American Indian or Alaska Native
3
   5.7%
4
   6.5%
7
   6.1%
Asian
4
   7.5%
1
   1.6%
5
   4.3%
Native Hawaiian or Other Pacific Islander
1
   1.9%
0
   0.0%
1
   0.9%
Black or African American
8
  15.1%
14
  22.6%
22
  19.1%
White
37
  69.8%
42
  67.7%
79
  68.7%
More than one race
0
   0.0%
1
   1.6%
1
   0.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: this section does not include Hispanic or Latino so these numbers were removed from the total RACE section.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 74 participants 78 participants 152 participants
74
 100.0%
78
 100.0%
152
 100.0%
Marital Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 78 participants 152 participants
Married/Living with partner
44
  59.5%
46
  59.0%
90
  59.2%
Single/Widowed
27
  36.5%
30
  38.5%
57
  37.5%
Divorced/Separated
3
   4.1%
0
   0.0%
3
   2.0%
Other (Unknown)
0
   0.0%
2
   2.6%
2
   1.3%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 78 participants 152 participants
< HS graduate
6
   8.1%
10
  12.8%
16
  10.5%
HS Graduate or equivalent
11
  14.9%
18
  23.1%
29
  19.1%
Some College
22
  29.7%
15
  19.2%
37
  24.3%
College Graduate
17
  23.0%
15
  19.2%
32
  21.1%
Not Reported
18
  24.3%
20
  25.6%
38
  25.0%
Tobacco Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 78 participants 152 participants
4
   5.4%
5
   6.4%
9
   5.9%
Illicit Drug Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 78 participants 152 participants
7
   9.5%
14
  17.9%
21
  13.8%
Gestational Age at Membrane Rupture  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 74 participants 78 participants 152 participants
25.9  (3.0) 26.6  (2.9) 26.2  (3.0)
Gestational Age at time of randomization (wks)  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 74 participants 78 participants 152 participants
26.7  (2.5) 27.1  (2.4) 26.9  (2.5)
Gestational Age Stratum at randomization (wks)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 78 participants 152 participants
23w0d-25w6d
31
  41.9%
28
  35.9%
59
  38.8%
26w0d - 28w6d
24
  32.4%
27
  34.6%
51
  33.6%
29w0d-30w6d
19
  25.7%
23
  29.5%
42
  27.6%
1.Primary Outcome
Title Gestational Age at Delivery
Hide Description Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.
Time Frame Measured from day of last menstrual cycle to day of birth and measured in weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (included all participants who were randomized, whether they received study medication or not).
Arm/Group Title 17-alpha Hydroxyprogesterone Caproate, Makena® Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 73 77
Mean (Standard Deviation)
Unit of Measure: weeks.
29.2  (2.72) 29.5  (2.74)
2.Secondary Outcome
Title Duration of Latency Period
Hide Description

Secondary Outcomes:

- Duration of latency period (time from randomization to birth)

Time Frame average number of days measured from day of study entry until day of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population (included all participants who were randomized, whether they received study medication or not).
Arm/Group Title 17-alpha Hydroxyprogesterone Caproate, Makena® Placebo
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 73 77
Mean (Standard Deviation)
Unit of Measure: days
17.1  (16.08) 17.0  (15.77)
Time Frame Up to 60 days post delivery or discharge which ever comes first
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neonate: 17-alpha Hydroxyprogesterone Caproate, Makena® Neonate: Placebo 17-alpha Hydroxyprogesterone Caproate, Makena® Placebo
Hide Arm/Group Description

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:

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.

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.

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.

All-Cause Mortality
Neonate: 17-alpha Hydroxyprogesterone Caproate, Makena® Neonate: Placebo 17-alpha Hydroxyprogesterone Caproate, Makena® Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/73 (4.11%)      2/77 (2.60%)      0/73 (0.00%)      0/77 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Neonate: 17-alpha Hydroxyprogesterone Caproate, Makena® Neonate: Placebo 17-alpha Hydroxyprogesterone Caproate, Makena® Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/73 (4.11%)      2/77 (2.60%)      0/73 (0.00%)      0/77 (0.00%)    
Cardiac disorders         
Suspected Pulmonary Hypertension  1 [1]  0/73 (0.00%)  0 1/77 (1.30%)  1 0/73 (0.00%)  0 0/77 (0.00%)  0
Congenital, familial and genetic disorders         
Congenital Diaphragmatic Hernia  1 [2]  1/73 (1.37%)  1 0/77 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0
Infections and infestations         
Respiratory Failure, Sepsis  1 [3]  1/73 (1.37%)  1 0/77 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Respiratory Distress  1 [4]  1/73 (1.37%)  1 0/77 (0.00%)  0 0/73 (0.00%)  0 0/77 (0.00%)  0
Atypical Pulmonary Infection  1 [5]  0/73 (0.00%)  0 1/77 (1.30%)  1 0/73 (0.00%)  0 0/77 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
[1]
For all enrolled participants the number who had a newborn death following suspected pulmonary hypertension.
[2]
For all enrolled participants the number who had a newborn with a diagnosis of congenital diaphragmatic hernia noted at time of birth.
[3]
For all enrolled participants the number who had a newborn with a neonatal death in association with neonatal sepsis and respiratory failure events.
[4]
For all enrolled participants the number who had a newborn with a neonatal death following respiratory distress.
[5]
For all enrolled participants the number who had a newborn with a neonatal deaths following a atypical pulmonary infection following birth
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neonate: 17-alpha Hydroxyprogesterone Caproate, Makena® Neonate: Placebo 17-alpha Hydroxyprogesterone Caproate, Makena® Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/73 (0.00%)      0/77 (0.00%)      0/73 (0.00%)      0/77 (0.00%)    
One limitation is that we only studied one dose of 17OHPc (250mg) and only one frequency (once a week) however we did this to coincide with the study that showed benefits of 17OHPc in women with intact membranes with a history of preterm birth.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kimberly Maurel
Organization: Mednax. Inc
Phone: 714-593-9171
Publications:
ACOG Committee on Obstetric Practice. Use of progesterone to reduce preterm birth. ACOG Committee Opinion 291: 1-2, American College of Obstetricians and Gynecologists, 2003
ACOG Committee on Practice Bulletins. Premature rupture of membranes. ACOG Practice Bulletin 80: 1-13, American College of Obstetricians and Gynecologists, 2007
Armstrong J, Nageotte M for the Society for Maternal-Fetal Medicine. Can progesterone prevent preterm birth? Contemp Obstet Gynecol 2005 (Oct);30-43
Responsible Party: Mednax Center for Research, Education, Quality and Safety ( Obstetrix Medical Group )
ClinicalTrials.gov Identifier: NCT01119963     History of Changes
Other Study ID Numbers: OBX0012
First Submitted: February 16, 2010
First Posted: May 10, 2010
Results First Submitted: March 20, 2018
Results First Posted: May 30, 2018
Last Update Posted: June 28, 2018