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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Preterm Delivery

In brief

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.

Key facts

Study ID

NCT01119963

Run by

Obstetrix Medical Group

People needed

152

Starts

2011-10-01

Expected to finish

2014-10-01

Last updated by the study team

2018-06-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Participant is 18 years old or older
• Gestational Age (GA) 23w0d and 30w6d @ time of enrollment
• Singleton pregnancy
• 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

You may not qualify if…

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

Where it is running

• University of South Alabama Medical Center — Mobile, Alabama, United States
• Desert Good Samaritan Hospital — Mesa, Arizona, United States
• Banner Good Samaritan Hospital — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Good Samaritan Hospital — San Jose, California, United States
• OConnor Hospital — San Jose, California, United States
• Swedish Medical Center — Denver, Colorado, United States
• Presbyterian/St Luke's Hospital — Denver, Colorado, United States
• Norton Kosair Children's Hospital — Louisville, Kentucky, United States
• Spectrum Health Hospital — Grand Rapids, Michigan, United States
• Saint Luke's Hospital, Kansas City — Kansas City, Missouri, United States
• Sunrise Medical Center — Las Vegas, Nevada, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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