Randomized Trial of Maternal Progesterone Therapy
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|ClinicalTrials.gov Identifier: NCT02133573|
Recruitment Status : Recruiting
First Posted : May 8, 2014
Last Update Posted : February 8, 2018
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Vaginal gel, 90mg twice a day (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
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
- 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)
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 ClinicalTrials.gov identifier (NCT number): NCT02133573
|Contact: Erin E Zullo, BSNfirstname.lastname@example.org|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Nancy Burnham, MSN 215-410-0721 email@example.com|
|Principal Investigator:||J. William Gaynor, MD||Children's Hospital of Philadelphia|