- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03026686
Postpartum Readmission
Postpartum Preeclampsia Readmission
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Preeclampsia is a pregnancy-specific multisystem disorder of unknown etiology. The disorder affects approximately 10 percent of pregnancies worldwide constituting one of the greatest causes of maternal and perinatal morbidity and mortality worldwide. (1) Preeclampsia is defined by the new onset of elevated blood pressure after 20 weeks of gestation. It is considered severe if blood pressure is increased substantially or symptoms of end-organ damage (including fetal growth restriction) occur. There is no single reliable, cost-effective screening test for preeclampsia, and there are no well-established measures for primary prevention. Management before the onset of labor includes close monitoring of maternal and fetal status. Management during delivery includes seizure prophylaxis with magnesium sulfate and, if necessary, medical management of hypertension. Delivery remains the ultimate treatment.
Preeclampsia leads to eclampsia. Symptoms of preeclampsia include: weight gain, headaches, right upper quadrant pain, swelling of hands and feet, and vision problems Symptoms of eclampsia include: muscle aches and pains, seizures, severe agitation, unconsciousness
Current obstetric treatment in the United States has resulted in a shift of eclampsia toward the postpartum period, with most cases being seen as late post partum. During the post partum period a patient's blood pressure peaks around 3-6 days post delivery, however most patients are discharged home by 48 hours. This results in re-admission to the hospital for some women. The investigator's goal is to review and evaluate women who have been readmitted for a preeclampsia or eclampsia episode during the post partum period to assess if there are preceding signs or symptoms leading to her re admission.
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Women who labored and delivered at a single hospital Readmitted (within 6 weeks post partum (PP) or less)to the hospital for hypertension disorder, with or without hypertension (HTN in pregnancy), gestational hypertension (gHTN), pre eclampsia (PreE), severe pre eclampsia (sPreE), HELLP ("HELLP" is an abbreviation of the three main features of the syndrome: Hemolysis. Elevated Liver enzymes. Low Platelet count.).
Controls Group with PreE, not readmitted or No PreE
Exclusion Criteria:
- Hospital readmission for other complications.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
readmit
women who were re-admitted in the post partum period for a hypertensive disorder
|
Controls
women with similar risk factors but did not require readmission
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
hypertension
Tidsram: 1 year
|
compare these two groups during the antepartum period, labor, delivery and post partum course for possible preceding signs (blood pressures) of those at risk for re admission for hypertensive disorders.
|
1 year
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 24998
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