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17-alpha-hydroxyprogesterone caproate injectable · 1 trial · 1 indication
Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support. Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used. Morbidity measures were based on live births with data available for the outcomes.
Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group.
Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics.
Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia
Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation. Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension.
Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter.
Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis.
Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy.
Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis).
Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization.
| Arm | Type | Description |
|---|---|---|
| 1 Test Group (170HP) | ACTIVE_COMPARATOR | Test Group will receive weekly doses of 170HP via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. |
| 2 - Control (Normal Saline) | PLACEBO_COMPARATOR | Control Group will receive weekly doses of placebo (NS) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. |
| Name | Type | Description |
|---|---|---|
| 17-alpha-hydroxyprogesterone caproate injectable | DRUG | 250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first. |
| Placebo | DRUG | Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. |
Inclusion Criteria: 1. Gestational age (GA) 15-23w0d gestational age at the time of recruitment 2. GA 16w0dk to 23w6d at the time of randomization and initiation of injections 3. Maternal age 18 years or older 4. One of these risk factors for spontaneous preterm birth: 1. Twins in current pregn...
17-alpha-hydroxyprogesterone caproate injectable is used for the prevention of preterm birth. It is being studied in twin and triplet pregnancies to reduce neonatal morbidity associated with preterm birth. The drug is a small molecule and is currently in Phase 2 clinical development.
17-alpha-hydroxyprogesterone caproate injectable is being developed by Pediatrix Medical Group, Inc., which trades under the ticker MD. The company is conducting clinical research on this drug for the prevention of preterm birth.
17-alpha-hydroxyprogesterone caproate injectable is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed for this drug.
17-alpha-hydroxyprogesterone caproate injectable has one completed clinical trial, NCT00163020, titled "17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies." This Phase 2 trial enrolled 321 participants in the United States and was placebo-controlled and double-blind.
17-alpha-hydroxyprogesterone caproate injectable is a small molecule that acts as a progestin, a synthetic form of the hormone progesterone. It is being studied for its ability to reduce the risk of preterm birth in women with twin or triplet pregnancies.
Yes, 17-alpha-hydroxyprogesterone caproate injectable is also known as 17OHP. The clinical trial NCT00163020 refers to the drug as 17OHP in its title, confirming that these names refer to the same investigational drug.