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Trial record 14 of 27 for:    "Periventricular Leukomalacia"

Randomized Trial of Maternal Progesterone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02133573
Recruitment Status : Recruiting
First Posted : May 8, 2014
Last Update Posted : February 6, 2019
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Maternal Progesterone Therapy to Improve Neurodevelopmental Outcomes in Infants With Congenital Heart Disease
Study Start Date : May 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Progesterone
Vaginal gel, 90mg twice a day (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 twice a day (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

Primary Outcome Measures :
  1. Motor Scale of the Bayley Scales of Infant and Toddler Development-III [ Time Frame: When baby is 18 months of age ]

Secondary Outcome Measures :
  1. Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III [ Time Frame: When baby is 18 months of age ]
  2. Fetal brain growth and maturation by MRI [ Time Frame: Change from 24-28 weeks gestational age to 34-36 weeks gestational age ]
  3. Myelination during fetal brain development by MRI [ Time Frame: Change from 24-28 weeks gestational age to 34-36 weeks gestational age ]
  4. Brain white matter injury by MRI [ Time Frame: Preoperative on day of surgery ]
    Heart surgery with cardiopulmonary bypass (CPB) prior to 44 weeks corrected gestational age (GA)

  5. Brain white matter injury by MRI [ Time Frame: Postoperative within 10 days of surgery ]
    Heart surgery with cardiopulmonary bypass (CPB) prior to 44 weeks corrected gestational age (GA)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02133573

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Contact: Erin E Zullo, BSN 215-360-8615

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United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nancy Burnham, MSN    215-410-0721   
Sponsors and Collaborators
Children's Hospital of Philadelphia
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Principal Investigator: J. William Gaynor, MD Children's Hospital of Philadelphia

Additional Information:
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Responsible Party: Children's Hospital of Philadelphia Identifier: NCT02133573     History of Changes
Other Study ID Numbers: 13-010710
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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

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