Phase 2
N=102
Randomized Trial of Maternal Progesterone Therapy
Congenital Heart Disease · Periventricular Leucomalacia · Brain Development · Cardiac Surgery · Neurodevelopmental Disability
Bottom Line
View on ClinicalTrials.gov: NCT02133573 ↗Enrolled (actual)
102
Serious AEs
44.8%
Results posted
Feb 2023
Primary outcome: Primary: Motor Scale of the Bayley Scales of Infant and Toddler Development-III — 90.0; 87.5; 88.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Progesterone (Drug); Vaginal lubricant (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Motor Scale of the Bayley Scales of Infant and Toddler Development-III |
90.0; 87.5; 88.7 | — |
| SECONDARY Cognitive and Language Scales of the Bayley Scale of Infant and Toddler Development-III |
92.4; 91.2; 91.8; 86.1; 84.5; 85.3 | — |
| SECONDARY Fetal Brain Growth and Maturation by MRI |
8.84; 8.35 | — |
| SECONDARY Myelination During Fetal Brain Development by MRI |
0.72; 0.69 | — |
| SECONDARY Prevalence of PVL/WMI in the Pre Operative Study Participants |
8; 9; 17; 27; 25; 52 | — |
| SECONDARY Prevalence of PVL/WMI in the Post Operative Study Participants |
18; 15; 33; 19; 21; 40 | — |
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.
Eligibility 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
- Major genetic or extra-cardiac anomaly other than 22q11 deletion
- Language other than English spoken in the home
- 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)
- Prescription or ingestion of medications known to interact with progesterone (e.g. Bromocriptine, Rifamycin, Ketoconazole or Cyclosporin)
- Maternal use of progesterone within 30 days of enrollment
- History of preterm birth or short cervix (defined as cervical length ≤ 25 mm at 18-24 weeks GA necessitating progesterone therapy
- Multiple gestation
- Maternal contraindication for magnetic resonance imaging (MRI)
- Subjects with a known history of non-compliance with medical therapy
Data sourced from ClinicalTrials.gov (NCT02133573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.