Winfred L. Wiser Hospital
Jackson, Mississippi, 39216, United States
Location status: Recruiting
Location contact
Babbette LaMarca, PhD
CONTACT
Sheila Belk, MSCI
CONTACT
NCT Number: NCT02989025
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Phase 2
Jackson, Mississippi, 39216, United States
Location status: Recruiting
Babbette LaMarca, PhD
CONTACT
Sheila Belk, MSCI
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.
Other names: Study Drug
Time frame: Baseline
Assessment of maternal BP trends
Time frame: 24 hours
Assessment of maternal BP trends
Time frame: 48 hours
Assessment of maternal BP trends
Time frame: Until delivery
Assessment of maternal BP trends
Time frame: Baseline until delivery
Assessment of Placental Abruption
Time frame: Change from Baseline until delivery
Assessment of Pulmonary edema
Time frame: Change from Baseline until delivery
Assessment of Acute Kidney Injury
Time frame: Change from Baseline until delivery
Assessment of DIC
Time frame: Change from Baseline until delivery
Assessment of neurological events
Time frame: Change from Baseline until delivery
Assessment of laboratory results
Time frame: Change from Baseline until delivery
Assessment of Biomarkers
Time frame: Delivery
Assessment of Infant Weight
Time frame: Delivery
Assessment of APGAR score
Time frame: Delivery
Assessment of NICU stays
Time frame: Delivery
Assessment of Interventricular hemorrhage
Time frame: Delivery
Assessment of Respiratory Distress Syndrome
Time frame: Delivery
Assessment of Necrotizing enterocolitis (NEC)
Contact information is provided by the study sponsor or research team.
Babbette LaMarca, PhD
CONTACT
Lorena M Amaral, Ph.D.
CONTACT
University of Mississippi Medical Center
Other
Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe/Superimposed Preeclampsia-The PROGRESS Pilot Study
Acronym: PROGRESS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07565727
Cardiometabolic Diseases, Diabetes Mellitus
Knoxville, Tennessee, United States
View Trial DetailsNCT07513558
Female Urogenital Diseases and Pregnancy Complications, Hypertension, Pregnancy-Induced
Graz, Austria
View Trial DetailsNCT06802861
Body Weight, Diabetes Mellitus
Knoxville, Tennessee, United States
View Trial DetailsNCT06915428
Abortion, Habitual, Abortion, Spontaneous
Chapel Hill, North Carolina, United States
View Trial Details