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

May 29, 2018 updated by: Obstetrix Medical Group

17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM), Double-blinded Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • University of South Alabama Medical Center
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Desert Good Samaritan Hospital
      • Phoenix, Arizona, United States, 85006
        • Banner Good Samaritan Hospital
      • Tucson, Arizona, United States, 85712
        • Tucson Medical Center
    • California
      • Long Beach, California, United States, 90801-1428
        • Long Beach Memorial Medical Center
      • San Jose, California, United States, 95124
        • Good Samaritan Hospital
      • San Jose, California, United States, 95128
        • OConnor Hospital
    • Colorado
      • Denver, Colorado, United States, 80110
        • Swedish Medical Center
      • Denver, Colorado, United States, 80218
        • Presbyterian/St Luke's Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Kosair Children's Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital, Kansas City
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sunrise Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0526
        • University of Cincinnati
    • Washington
      • Seattle, Washington, United States, 98122-4307
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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:
  • Progesterone
  • 17 alpha hydroxyprogesterone Caproate
  • 17P
  • 17Pc
  • 17HP
  • 170HP
  • 170HPC
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured from day of last menstrual cycle to day of birth and measured in weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
average number of days measured from day of study entry until day of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obstetrix Medical Group

Investigators

  • Principal Investigator: Andrew Combs, MD, Obstetrix Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 10, 2010

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBX0012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Delivery

Clinical Trials on 17-alpha-hydroxy-progesterone caproate, Makena®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe