Randomized Trial of Maternal Progesterone Therapy
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.
|Congenital Heart Disease Periventricular Leucomalacia Brain Development Cardiac Surgery Neurodevelopmental Disability Fetal Neuroprotection||Drug: Progesterone Drug: Vaginal lubricant||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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|
- Motor Scale of the Bayley Scales of Infant and Toddler Development-III [ Time Frame: When baby is 18 months of age ]
- Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III [ Time Frame: When baby is 18 months of age ]
- Fetal brain growth and maturation by MRI [ Time Frame: Change from 24-28 weeks gestational age to 34-36 weeks gestational age ]
- Myelination during fetal brain development by MRI [ Time Frame: Change from 24-28 weeks gestational age to 34-36 weeks gestational age ]
- 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)
- 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)
|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)|
Vaginal gel, 90mg BID
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02133573
|Contact: Erin E Zullo, BSNemail@example.com|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Nancy Burnham, MSN 215-410-0721 firstname.lastname@example.org|
|Principal Investigator:||J. William Gaynor, MD||Children's Hospital of Philadelphia|