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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
Information provided by (Responsible Party):
Pediatrix ( Obstetrix Medical Group )

Brief Summary:

The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will:

  1. increase the probability of continuing the pregnancy until a favorable gestational age.
  2. increase the interval between randomization and delivery.
  3. decrease neonatal morbidity.

Condition or disease Intervention/treatment Phase
Preterm Delivery Drug: 17-alpha-hydroxy-progesterone caproate, Makena® Drug: Castor Oil (Placebo) Phase 2 Phase 3

Detailed Description:

Preterm rupture of the membranes (PROM) is the leading identifiable cause of prematurity and accounts for about one-third of all preterm deliveries and 18-20% of perinatal deaths in the USA. When PROM occurs at very early gestational ages, the clinician must make a decision whether to attempt to prolong the pregnancy or whether to recommend prompt delivery. Both approaches carry substantial risk. The strategy of continuing the pregnancy is commonly called "expectant management." During expectant management, gestational age steadily increases, and the balance naturally shifts toward favoring delivery. Once the gestational age reaches 34 weeks, the risk of lethal or permanent sequelae of prematurity or minimal, so most clinicians agree that delivery is warranted. Despite an attempt at expectant management, the majority of patients with PROM will be delivered within the first week or so. Unfortunately, no intervention other than antibiotic prophylaxis or corticosteroids have been shown to prolong latency or reduce neonatal morbidity after PROM. Recent evidence suggests that prophylactic administration of progesterone medications may reduce the risk of preterm delivery in women with certain risk factors, notably those with a history of a prior preterm delivery and those with a shortened cervix discovered by ultrasound examination. Clearly, women with PROM are at very high risk of preterm delivery, so there is a pressing need to study whether 17 hydroxyprogesterone caproate (17P) is effective after PROM. Progesterone might be beneficial after PROM both because it tends to promote uterine quiescence by suppressing the formation of myometrial gap junctions and because it has anti-inflammatory properties, suppressing the production of inflammatory cytokines and thereby inhibiting cervical ripening. Inflammation is a major pathway leading to preterm labor, cervical dilation & preterm delivery. 17P would seem to be like an ideal candidate for prolongation of pregnancy after PROM.

This is a double-blinded, placebo-controlled, multicenter, randomized clinical trial of 17P versus placebo. The primary outcome measure will be the percentage of each group reaching either a gestational age of 34w0d or documentation of fetal lung maturity at 32w0d to 33w6d. Secondary outcomes will include the latency period for each group and the percentage of newborns in each group who have major neonatal morbidity or death.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM), Double-blinded Randomized Clinical Trial
Study Start Date : October 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy Tears

Arm Intervention/treatment
Active Comparator: 17-alpha hydroxyprogesterone caproate, Makena®
250 mg of 17P, Makena® intramuscular (IM) weekly.
Drug: 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.
Other Names:
  • 17 alpha hydroxyprogesterone Caproate
  • 17P
  • 17Pc
  • 17HP
  • 170HP
  • 170HPC
  • Progesterone
  • Makena®

Placebo Comparator: Placebo
Castor Oil (Placebo)intramuscular (IM) weekly
Drug: 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.
Other Names:
  • Placebo
  • Castor Oil

Primary Outcome Measures :
  1. Gestational Age at Delivery [ Time Frame: Measured from day of last menstrual cycle to day of birth and measured in weeks. ]
    Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.

Secondary Outcome Measures :
  1. Duration of Latency Period [ Time Frame: average number of days measured from day of study entry until day of delivery ]

    Secondary Outcomes:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Participant is 18 years old or older
  2. Gestational Age (GA) 23w0d and 30w6d @ time of enrollment
  3. Singleton pregnancy
  4. PROM defined as either (a) or (b) or (c) below (a) Documentation of vaginal leakage of indigo carmine dye instilled via amniocentesis (b) Positive Amnisure® test (c) Two or more of (i) through (iv): i. Nitrazine test with pH of 7 or more ii. Positive fern test iii. Gross pooling of clear fluid iv. US exam showing oligohydramnios

Exclusion Criteria:

  1. Any contraindication to expectant management
  2. Any fetal condition likely to cause serious neonatal morbidity independent of gestational age
  3. History of allergy to 17P
  4. Any contraindications to 17P use (e.g. Thrombosis, Breast CA, abnormal vaginal bleeding unrelated to pregnancy, jaundice, liver disease, uncontrolled HTN)
  5. Any medical condition currently treated with systemic steroid medications
  6. Cervical cerclage present at the time of PROM
  7. Informed consent not obtained.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119963

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United States, Alabama
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
United States, Arizona
Desert Good Samaritan Hospital
Mesa, Arizona, United States, 85202
Banner Good Samaritan Hospital
Phoenix, Arizona, United States, 85006
Tucson Medical Center
Tucson, Arizona, United States, 85712
United States, California
Long Beach Memorial Medical Center
Long Beach, California, United States, 90801-1428
Good Samaritan Hospital
San Jose, California, United States, 95124
OConnor Hospital
San Jose, California, United States, 95128
United States, Colorado
Swedish Medical Center
Denver, Colorado, United States, 80110
Presbyterian/St Luke's Hospital
Denver, Colorado, United States, 80218
United States, Kentucky
Norton Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Michigan
Spectrum Health Hospital
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Saint Luke's Hospital, Kansas City
Kansas City, Missouri, United States, 64111
United States, Nevada
Sunrise Medical Center
Las Vegas, Nevada, United States, 89109
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0526
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122-4307
Sponsors and Collaborators
Obstetrix Medical Group
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Principal Investigator: Andrew Combs, MD Obstetrix Medical Group
ACOG Committee on Obstetric Practice. Antenatal corticosteroid therapy for fetal maturation. ACOG Committee Opinion 273: 1-3, American College of Obstetricians and Gynecologists, 2002.
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT01119963    
Other Study ID Numbers: OBX0012
First Posted: May 10, 2010    Key Record Dates
Results First Posted: May 30, 2018
Last Update Posted: June 28, 2018
Last Verified: May 2018
Keywords provided by Pediatrix ( Obstetrix Medical Group ):
Preterm delivery
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Castor Oil
17 alpha-Hydroxyprogesterone Caproate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Gastrointestinal Agents