Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Randomized Trial of Maternal Progesterone Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT02133573
First received: May 7, 2014
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

Neurodevelopmental disability is now recognized as the most common long-term complication after cardiac surgery in neonates. Research studies have shown that progesterone is critical to the development of the brain and in a variety of clinical situations including brain injury can protect the brain.

The purpose of this research study is to determine whether progesterone administered during the 3rd trimester of pregnancy (24-39 weeks) to pregnant women protects the brain of unborn babies with CHD and improves their neurodevelopmental outcomes after heart surgery.


Condition Intervention Phase
Congenital Heart Disease
Periventricular Leucomalacia
Brain Development
Cardiac Surgery
Neurodevelopmental Disability
Fetal Neuroprotection
Drug: Progesterone
Drug: Vaginal lubricant
Phase 2

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: Treatment
Official Title: Randomized Trial of Maternal Progesterone Therapy to Improve Neurodevelopmental Outcomes in Infants With Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Motor Scale of the Bayley Scales of Infant and Toddler Development-III [ Time Frame: When baby is 18 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III [ Time Frame: When baby is 18 months of age ] [ Designated as safety issue: No ]
  • Fetal brain growth and maturation by MRI [ Time Frame: Change from 24-28 weeks gestational age to 34-36 weeks gestational age ] [ Designated as safety issue: No ]
  • Myelination during fetal brain development by MRI [ Time Frame: Change from 24-28 weeks gestational age to 34-36 weeks gestational age ] [ Designated as safety issue: No ]
  • Brain white matter injury by MRI [ Time Frame: Preoperative on day of surgery ] [ Designated as safety issue: No ]
    Heart surgery with cardiopulmonary bypass (CPB) prior to 44 weeks corrected gestational age (GA)

  • Brain white matter injury by MRI [ Time Frame: Postoperative within 10 days of surgery ] [ Designated as safety issue: No ]
    Heart surgery with cardiopulmonary bypass (CPB) prior to 44 weeks corrected gestational age (GA)


Estimated Enrollment: 130
Study Start Date: May 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Progesterone
Vaginal gel, 90mg BID
Drug: Progesterone
Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
Other Name: Crinone 8%
Placebo Comparator: Vaginal Lubricant
Vaginal BID
Drug: Vaginal lubricant
Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
Other Name: Replens

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Mother carrying a fetus with CHD (maternal-fetal dyad) requiring surgery with cardiopulmonary bypass (CPB) prior to 44 weeks corrected gestational age (GA) identified prior to 28 weeks GA.

Exclusion Criteria:

  1. Major genetic or extra-cardiac anomaly other than 22q11 deletion
  2. Language other than English spoken in the home
  3. Known sensitivity or listed contraindication to progesterone (known allergy or hypersensitivity to progesterone, severe hepatic dysfunction, undiagnosed vaginal bleeding, mammary or genital tract carcinoma, thrombophlebitis, thromboembolic disorders, cerebral hemorrhage, porphyria)
  4. Prescription or ingestion of medications known to interact with progesterone (e.g. Bromocriptine, Rifamycin, Ketoconazole or Cyclosporin)
  5. Maternal use of progesterone within 30 days of enrollment
  6. History of preterm birth or short cervix (defined as cervical length ≤ 25 mm at 18-24 weeks GA necessitating progesterone therapy
  7. Multiple gestation
  8. Maternal contraindication for magnetic resonance imaging (MRI)
  9. Subjects with a known history of non-compliance with medical therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02133573

Contacts
Contact: Katherine Drangula, BSN 215-906-9596 drangulak@email.chop.edu
Contact: Nancy Burnham, MSN 215-410-0721 burnhamn@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katherine Drangula, BSN    267-844-1155    drangulak@email.chop.edu   
Contact: Nancy Burnham, MSN    215-410-0721    burnhamn@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: J. William Gaynor, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02133573     History of Changes
Other Study ID Numbers: 13-010710
Study First Received: May 7, 2014
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
progesterone
congenital heart disease
periventricular leucomalacia
brain development
cardiac surgery
neurodevelopmental disability
fetus
fetal neuroprotection

Additional relevant MeSH terms:
Leukomalacia, Periventricular
Heart Defects, Congenital
Heart Diseases
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Congenital Abnormalities
Encephalomalacia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Nervous System Diseases
Vascular Diseases
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on November 20, 2014