Clinical Trials Logo

Clinical Trial Summary

This is a prospective single centered randomized control study for postpartum patients diagnosed with hypertension. Participants that meet inclusion criteria will be approached while they are inpatient. After enrollment, all study subjects will receive an automated blood pressure cuff and instructions on how to use it. Study participants in the intervention group will be provided with educational material. The investigators hypothesize education in postpartum women with hypertension can improve patient compliance with attendance at postpartum care appointments.


Clinical Trial Description

The study group: postpartum women with a diagnosis of either chronic hypertension, gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, chronic hypertension with superimposed preeclampsia with and without severe features. Recruitment: postpartum patients that meet the inclusion criteria will be approached postpartum while they are still hospitalized. Once the study subjects are enrolled, they will receive the same automatic blood pressure cuff and basic teaching on how to use it. All study subjects will be asked to check their blood pressure once a day. The study subjects will be advised that if systolic blood pressure is > 160 or the diastolic blood pressure >110, the study subjects are asked to remain seated and repeat the BP measurement in 15 minutes, if still elevated the study subject will be advised to call labor and delivery or proceed to labor and delivery triage for further evaluation. All study subjects will be asked to follow up for a blood pressure check 3-10 days after discharge home. All study subjects will be weighed prior to discharge. The study subject is then randomized to the control or intervention group. Both groups will receive a survey. After the intervention group undergoes the educational component, this will be the last time the study subjects meet with the investigator. The data will be collected on an excel spreadsheet. Patient identifiers will be removed once the study is completed. However, de-identified data may be used for future studies. The database will be password protected on an excel spreadsheet and secured behind the Medstar Washington Hospital Center firewall computers. Access to these databases is restricted to the PI and the co-investigators. The data will be statistically analyzed in order to answer the primary and secondary outcomes. Power analysis: At Washington hospital center, the current attendance within 10 day postpartum follow up appointments is 40% and at the 6 week appointment it is 70%. Based on this data the investigator wants to evaluate if this postpartum education intervention can cause a 100% difference in attendance within 10 days postpartum: 40% attendance which is the current attendance rate (control) versus 80% (goal for the intervention group): enrollment of 46 patients is required. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04486170
Study type Interventional
Source Medstar Health Research Institute
Contact
Status Completed
Phase N/A
Start date September 14, 2020
Completion date December 15, 2021

See also
  Status Clinical Trial Phase
Completed NCT00974714 - L-arginine Effects on Chronic Hypertension in Pregnancy Phase 3
Terminated NCT03595982 - Is Procardia XL 60 mg Q Daily Equivalent to 30 mg XL Given Twice Daily? Phase 4
Completed NCT03506724 - Response to Anti-hypertensives in Pregnant and Postpartum Patients Phase 4
Completed NCT03613714 - Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy N/A
Recruiting NCT04604535 - The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy N/A
Completed NCT00412230 - Insulin Resistance and Hypertensive Disorders in Pregnancy N/A
Active, not recruiting NCT05049616 - Oral Combined Hydrochlorothiazide/Lisinopril Versus Oral Nifedipine for Postpartum Hypertension Phase 4
Completed NCT04119232 - Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy N/A
Completed NCT04633551 - Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes N/A
Completed NCT05859282 - Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension
Active, not recruiting NCT05543265 - Bridging the Gap From Postpartum to Primary Care N/A
Completed NCT00571766 - Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy Phase 3
Recruiting NCT05473767 - Expanding the Family Check-Up in Early Childhood to Promote Cardiovascular Health of Mothers and Young Children N/A
Recruiting NCT05683093 - Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood
Completed NCT06403722 - Perinatal Outcomes in Patients With Elevated sFlt-1/PlGF Ratio
Recruiting NCT05852054 - Supporting Transitions to Primary Care Among Under-resourced, Postpartum Women (STEP-UP) Phase 3
Recruiting NCT05137808 - Understanding Blood Pressure Changes After Birth
Completed NCT03961360 - Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida Phase 2/Phase 3
Active, not recruiting NCT03648645 - Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure N/A
Recruiting NCT06054841 - Reshaping Postpartum Follow-up N/A