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

This study is currently recruiting participants.
Verified September 2013 by Obstetrix Medical Group
Sponsor:
Information provided by (Responsible Party):
Obstetrix Medical Group
ClinicalTrials.gov Identifier:
NCT01119963
First received: February 16, 2010
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Obstetrix Medical Group:

Primary Outcome Measures:
  • Interval from PROM until delivery of 34w0d which ever comes first. [ Time Frame: measured from PROM until 34w0d or delivery if that comes first. ] [ Designated as safety issue: Yes ]
    Measures in average time in hours from PROM until 34w0d of gestation or delivery is that comes first.


Secondary Outcome Measures:
  • Duration of latency period [ Time Frame: average number of hours measured from randomization until birth ] [ Designated as safety issue: Yes ]

    Secondary Outcomes:

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



Estimated Enrollment: 222
Study Start Date: October 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119963

Contacts
Contact: Kimberly A Maurel, MSN 714-593-9171 kimberly_maurel@pediatrix.com
Contact: Diana Abril, MS 480-659-8644 diana_abril@pediatrix.com

Locations
United States, Alabama
University of South Alabama Medical Center Recruiting
Mobile, Alabama, United States, 36617
Contact: David Lewis, MD    251-415-1598    davidlewis@usouthal.edu   
Contact: Casey Armestead    251-415-1598    marmestead@usouthal.edu   
Principal Investigator: David Lewis, MD         
United States, Arizona
Desert Good Samaritan Hospital Recruiting
Mesa, Arizona, United States, 85202
Contact: William Clewell, MD    480-469-5999 ext 201    William_Clewell@pediatrix.com   
Contact: Melissa Ingersoll, RN,    602-239-3632 office    Melissa_ingersoll@pediatrix.com   
Principal Investigator: William Clewell, MD         
Banner Good Samaritan Hospital Recruiting
Phoenix, Arizona, United States, 85006
Contact: William Clewell, MD    480-969-5999 ext 201    William_Clewell@pediatrix.com   
Contact: Melissa Ingersoll, RN    602-239-3632    melissa_ingersoll@pediatrix.com   
Principal Investigator: William Clewell, MD         
Tucson Medical Center Recruiting
Tucson, Arizona, United States, 85712
Contact: Miller Hugh, MD    520-795-8188    hmiller@ahsc.arizona.edu   
Contact: Diane Mercer, RN    (520) 881-9662    mercer.diane@gmail.com   
Principal Investigator: Hugh Miller, MD         
United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90801-1428
Contact: Michael Nageotte, MD    562-933-2730    Michael_nageotte@pediatrix.com   
Contact: Deysi Caballero, LVN    562-933-2730    dcaballero@memorialcare.org   
Principal Investigator: Michael Nageotte, MD         
Good Samaritan Hospital Recruiting
San Jose, California, United States, 95124
Contact: Andrew Combs, MD    408-371-7111    andrew_combs@pediatrix.com   
Contact: Kimberly Mallory, RN    408-559-2327    kimberly_mallory@pediatrix.com   
Principal Investigator: Andrew Combs, MD         
OConnor Hospital Recruiting
San Jose, California, United States, 95128
Contact: Andrew Combs, MD    408-371-7111    andrew_combs@pediatrix.com   
Contact: Kimberly Mallory, BSN    408-371-7111    kimberly_mallory@pediatrix.com   
Principal Investigator: Andrew Combs, MD         
United States, Colorado
Presbyterian/St Luke's Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Richard Porreco, MD    303-860-9990    richard_porreco@pediatrix.com   
Contact: Julie Rael, RN    303-570-8138    julie_rael@pediatrix.com   
Principal Investigator: Richard Porreco, MD         
Swedish Medical Center Recruiting
Denver, Colorado, United States, 80110
Contact: Kent Heyborne, MD    303-860-9990    kent_heyborne@pediatrix.com   
Contact: Jeri Lech, RN    303-523-0719    jeri_lech@pediatrix.com   
Principal Investigator: Kent Heyborne, MD         
United States, Kentucky
Norton Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Helen How, MD    513-403-6469    Helen.how@nortonhealthcare.org   
Contact: Christina Soto-Waldon, RN    502-899-6931    Christina.soto@nortonhealthcare.org   
Principal Investigator: Helen How, MD         
United States, Michigan
Spectrum Health Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Asad Sheikh, MD    616-391-3681    asad.sheikh@spectrum-health.org   
Contact: Lori Oosterman, RN    616-486-2085    lori.oosterman@spectrum-health.org   
Principal Investigator: Asad Sheikh, MD         
United States, Missouri
Saint Luke's Hospital, Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: George Lu    816-932-6903    glu@saint-lukes.org   
Principal Investigator: George Lu, MD         
United States, Nevada
Sunrise Medical Center Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Wilson Huang, MD    702-382-3200 ext 1    whuang@mfmcenter.com   
Contact: Judy Hancock, RN    702-382-3200 ext #1    judyk@SonoranSys.com   
Principal Investigator: Wilson Huang, MD         
United States, Ohio
University of Cincinnati Terminated
Cincinnati, Ohio, United States, 45267-0526
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Lan Tran, MD    206-386-2101    Lan_Tran@pediatrix.com   
Contact: Tina Lopez, RN    206-215-3541    tina_lopez@pediatrix.com   
Principal Investigator: Lan Tran, MD         
Sub-Investigator: David Luthy, MD         
Sponsors and Collaborators
Obstetrix Medical Group
Investigators
Principal Investigator: Andrew Combs, MD Obstetrix Medical Group
  More Information

Publications:
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: Obstetrix Medical Group
ClinicalTrials.gov Identifier: NCT01119963     History of Changes
Other Study ID Numbers: OBX0012
Study First Received: February 16, 2010
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Obstetrix Medical Group:
Preterm delivery

Additional relevant MeSH terms:
Premature Birth
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Castor Oil
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Progesterone
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists

ClinicalTrials.gov processed this record on April 17, 2014