An observational study in Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial, sponsored by AMAG Pharmaceuticals, Inc.. Completed at 40 sites in 7 countries. Open to participants aged 22 Months to 25 Months. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by AMAG Pharmaceuticals, Inc. · Observational
In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic (Protocol number 17P-ES-003).
This will be a prospective, noninterventional follow-up study designed to provide a developmental assessment of children born to mothers who participated in the 17P Efficacy Trial. When subjects reach an age of 23 months after adjustment for gestational age, they will be screened for developmental delay using the 24 month ASQ version 3. Subjects who score positive (fall below the specified cut-off) for developmental delay in 1 or more domains will be referred for the 24 month Bayley Scales of Infant and Toddler Development (3rd edition, Bayley-III) and a neurological examination.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 245 is above the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →AMAG Pharmaceuticals, Inc. is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
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Children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial
Maternal enrollment which resulted in a live birth in the 17P Efficacy Trial: A Multi-center, Randomized, Double-blind Study of Hydroxyprogesterone Caproate Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery.
Exclusion Criteria:
Infants Born to Mothers Who Participated in the 17P-ES-003 Study and whose mothers consented for them to be followed for this study.
Drug: ASQ-3, Bayley III, Neurologic exam
Developmental Scales of infant development - Children born to mothers who participated in the 17P-ES-003 study will be enrolled in this study and evaluated using the ASQ-3. Those meeting protocol criteria based on ASQ-3, will be evaluated using the Bayley III and have a neurologic examination.
Determine whether there is a difference in developmental status between children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial
The primary objective of this study is to determine whether there is a difference in developmental status between children, aged 23 to 25 months after adjustment for gestational age, whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial.
Time frame: aged 23 to 25 months
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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AMAG Pharmaceuticals, Inc.