Postpartum Readmission

Postpartum Hypertension Clinical Trial

Official title:

Postpartum Preeclampsia Readmission

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03026686
• Other study ID #: 24998
• Status: Terminated
• Phase: N/A
• First received: January 18, 2017
• Last updated: October 10, 2017
• Start date: January 2017
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective chart review of women who labored and delivered in a single health care center. From that large group the investigators will evaluate women who were re-admitted in the post partum period for a hypertensive disorder. The study will also look at "Controls," a group of women with similar risk factors but did not require readmission.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 335
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postpartum Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypertension	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