[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02989025":3,"trial-entities:NCT02989025":110,"trial-summary:NCT02989025":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":73,"locations":75,"central_contacts":95,"overall_officials":100,"references":108,"see_also_links":109},"NCT02989025","2015-0029","Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe\u002FSuperimposed Preeclampsia","Progesterone to Enhance the Efficacy and Success of Expectantly Managed Preterm Severe\u002FSuperimposed Preeclampsia-The PROGRESS Pilot Study","RECRUITING","2027-01-31","2026-04","2026-05-01","2017-05-22","University of Mississippi Medical Center","OTHER",true,"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.",[19,20],"Pregnancy","Preeclampsia (PE)",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},60,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","17 OHPC","The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.",[35],"Experimental",[37],"Study Drug",[39],{"measure":40,"description":41,"timeFrame":42},"Improvement of maternal and perinatal outcomes","Assessment of maternal BP trends","Baseline",[44],{"measure":45,"description":41,"timeFrame":46},"Change is being assessed in Maternal Outcomes","24 hours","FEMALE","18 Years","45 Years",false,{"inclusion":52,"exclusion":55,"raw_text":72},[53,54],"UMMC antepartum patients with preterm PE between 23 0\u002F7ths and 34 0\u002F7ths weeks gestation when initially evaluated","Willing and able to understand study procedures and to provide informed consent",[56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"\\>33 weeks gestational age or \\\u003C23 weeks gestation","Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).","Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations, minimal to absent fetal heart rate variability).","Parameters according to current practice guidelines that exclude a patient from expectant management include the following:","Preterm premature rupture of membranes (PPROM) \\> 34 weeks gestation;","Platelet count \\\u003C 100,000\u002Fmicroliter (thrombocytopenia) with evidence of HELLP syndrome;","Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);","Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);","Severe Oligohydramnios (AFI \\\u003C 5cm)","Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;","Recurrent (\\> 2 readings \\> 30 minutes apart) severe hypertension despite antihypertensive therapy;","Eclampsia;","Pulmonary edema;","Abruption placentae;","Nonreassuring fetal status during daily testing (biophysical profile \\\u003C4\u002F10 and\u002For recurrent variable or late decelerations);","IUFD","Inclusion Criteria:\n\n* UMMC antepartum patients with preterm PE between 23 0\u002F7ths and 34 0\u002F7ths weeks gestation when initially evaluated\n* Willing and able to understand study procedures and to provide informed consent\n\nExclusion Criteria:\n\n* \\>33 weeks gestational age or \\\u003C23 weeks gestation\n* Maternal compromise requiring emergent delivery (ongoing placental abruption, DIC, pulmonary edema).\n* Fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations, minimal to absent fetal heart rate variability).\n* Parameters according to current practice guidelines that exclude a patient from expectant management include the following:\n* Preterm premature rupture of membranes (PPROM) \\> 34 weeks gestation;\n* Platelet count \\\u003C 100,000\u002Fmicroliter (thrombocytopenia) with evidence of HELLP syndrome;\n* Persistently abnormal hepatic enzyme concentrations (twice or more upper normal values);\n* Severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile);\n* Severe Oligohydramnios (AFI \\\u003C 5cm)\n* Reversal of end diastolic flow(REDF) in umbilical artery Doppler testing;\n* Recurrent (\\> 2 readings \\> 30 minutes apart) severe hypertension despite antihypertensive therapy;\n* Eclampsia;\n* Pulmonary edema;\n* Abruption placentae;\n* Nonreassuring fetal status during daily testing (biophysical profile \\\u003C4\u002F10 and\u002For recurrent variable or late decelerations);\n* IUFD",[74],"ADULT",[76],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":92},"Winfred L. Wiser Hospital","Jackson","Mississippi","39216","United States",[83,88],{"name":84,"role":85,"phone":86,"email":87},"Babbette LaMarca, PhD","CONTACT","(601)815-1430","bblamarca@umc.edu",{"name":89,"role":85,"phone":90,"email":91},"Sheila Belk, MSCI","(601)984-1690","sbelk@umc.edu",{"lat":93,"lon":94},32.29876,-90.18481,[96,97],{"name":84,"role":85,"phone":86,"email":87},{"name":98,"role":85,"email":99},"Lorena M Amaral, Ph.D.","lmamaral@umc.edu",[101,104],{"name":84,"affiliation":102,"role":103},"University of Missisippi Medical Center","PRINCIPAL_INVESTIGATOR",{"name":105,"affiliation":106,"role":107},"Sheila S Belk","UMMC Pharmacology and Toxicology","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":113},[112],"Preeclampsia",[],{"nct_id":4,"found":15,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 women.","completed","Progesterone for Preeclampsia Before 34 Weeks","This study is looking at whether giving 17-hydroxyprogesterone caproate (17 OHPC) can improve outcomes for mothers and babies when preeclampsia is diagnosed early in pregnancy (before 34 weeks). Preeclampsia is a serious pregnancy complication characterized by high blood pressure and signs of damage to another organ system, most often the liver and kidneys. You may be able to join if you are a woman between 18 and 45 years old, are pregnant with preeclampsia between 23 and 34 weeks gestation, and are a patient at UMMC. The study aims to see if this treatment leads to better health for both mother and baby. The current status of this study is unclear, and it plans to enroll 60 participants.","Information about the mother and newborn will be collected while in the hospital and until discharge.",118,"If you join, you will receive 17 OHPC injections at admission and every 7 days. Blood samples will be taken at various times until after delivery, and your placenta will be collected after birth.","Not stated in the trial record.",[32],"v2"]