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The purpose of this study is to learn if giving 17-hydroxyprogesterone caproate (17 OHPC) to mothers with preeclampsia diagnosed before 34 weeks gestation improves mother and baby outcomes.
The OBGYN house and attending staff on duty caring for the patient will determine appropriateness for study inclusion. The treating physician will then immediately contact the MFM fellow on call and Research Division personnel to facilitate the initiation of study procedures, including the consent process and baseline blood tests. Once enrolled with informed consent, the participant will receive 17 OHPC, 250mg IM to be given at admission and every 7 days thereafter. Blood sampling of approximately 1-2 teaspoons each will be collected at baseline immediately prior to administration of 17 OHPC, then 24 hours (+-2hrs). After the first 24 hours, blood samples will be collected every 72 hrs until delivery and again 24hrs (+- 2hrs) after delivery. Placentas will be collected at delivery and the investigators will also collect information of the mother and newborn while in the hospital and until discharge including de-identified routine ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | To determine if the addition of 17 OHPC to the management of Severe PE diagnosed prior to 34 weeks gestation improves maternal and perinatal outcomes. |
|
| Control | No Intervention | To determine how close the molecular markers are with 17 OHPC added to the management protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17 OHPC | Drug | The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of maternal and perinatal outcomes | Assessment of maternal BP trends | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change is being assessed in Maternal Outcomes | Assessment of maternal BP trends | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change is being assessed in Maternal Outcomes | Assessment of maternal BP trends | 48 hours |
| Change is being assessed in Maternal Outcomes | Assessment of maternal BP trends |
Inclusion Criteria:
Exclusion Criteria:
Female only
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Babbette LaMarca, PhD | Contact | (601)815-1430 | bblamarca@umc.edu | |
| Lorena M Amaral, Ph.D. | Contact | lmamaral@umc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Babbette LaMarca, PhD | University of Missisippi Medical Center | Principal Investigator |
| Sheila S Belk | UMMC Pharmacology and Toxicology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winfred L. Wiser Hospital | Recruiting | Jackson | Mississippi | 39216 | United States |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| Until delivery |
| Assessment of Placental Abruption | Assessment of Placental Abruption | Baseline until delivery |
| Assessment of Pulmonary edema | Assessment of Pulmonary edema | Change from Baseline until delivery |
| Assessment of Acute Kidney Injury | Assessment of Acute Kidney Injury | Change from Baseline until delivery |
| Assessment of DIC | Assessment of DIC | Change from Baseline until delivery |
| Assessment of neurological events | Assessment of neurological events | Change from Baseline until delivery |
| Assessment of laboratory results | Assessment of laboratory results | Change from Baseline until delivery |
| Assessment of Biomarkers | Assessment of Biomarkers | Change from Baseline until delivery |
| Assessment of Infant Weight | Assessment of Infant Weight | Delivery |
| Assessment of APGAR score | Assessment of APGAR score | Delivery |
| Assessment of NICU stays | Assessment of NICU stays | Delivery |
| Assessment of Interventricular hemorrhage | Assessment of Interventricular hemorrhage | Delivery |
| Assessment of Respiratory Distress Syndrome | Assessment of Respiratory Distress Syndrome | Delivery |
| Assessment of Necrotizing enterocolitis (NEC) | Assessment of Necrotizing enterocolitis (NEC) | Delivery |