Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum

Normotensive Postpartum Cesarean Section Patients Clinical Trial

Official title:

Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02912403
• Other study ID #: 27285
• Status: Withdrawn
• Phase: N/A
• First received: August 22, 2016
• Last updated: March 3, 2017
• Start date: August 2016
• Est. completion date: August 2018

Study information

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

Clinical Trial Summary

Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period. Investigators will use a home blood pressure monitor that stays on the arm, and takes blood pressures hourly. Participants will record any symptoms that they feel are attributed to high blood pressure and pain medication use.

Description:

Participants will be screened postpartum for inclusion. Only women with cesarean deliveries will be included as they are kept for 3 days in the hospital as opposed to 2 days for vaginal deliveries. If they meet inclusion criteria they will be asked to participate in the study, and consented. Each patient will receive routine postpartum care. The ambulatory blood pressure cuff will be introduced and validated on the particpant prior to discharge. Particpants will then be given specific instructions on when to place the cuff on their am and when to remove it. The ambulatory cuff will take blood pressure measurements every hour. The Particpant will be asked to keep a log of actives, symptoms, and pain medication use for the 72 hour period that her blood pressures are being recorded. The BP device will be returned to the department of OB/GYN at St. Mary's after completion of her 72 hours of monitoring. This will occur at her first post op visit. Particpants will be asked to complete a survey about comfort of device and return with the device. Information pertaining to their pregnancy and delivery will be collected while the patient is in the hospital. Particpants are not responsible for damage or loss of equipment.

All of these procedures are part of the study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 40 Years

Eligibility

Inclusion Criteria:

• Normotensive postpartum women

• Singleton pregnancy

• Cesarean delivery

Exclusion Criteria:

• Chronic medical conditions that would put the patient at increased risk for hypertension (diabetes, lupus, renal disease)

• Current diagnosis of hypertensive disease

• Skin rash in location of cuff placement

• Tobacco user

• Chronic narcotic user

• Vaginal delivery

• cognitively impaired persons

Related Conditions & MeSH terms

• Normotensive Postpartum Cesarean Section Patients

Locations

Country	Name	City	State
United States	St. Mary's Health Center	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure changes on days 3 to 6 of the postpartum period	To determine the normal blood pressure trends for women with uncomplicated pregnancies during days 3 to 6 of the postpartum period. These days are historically considered the "at risk days" for rising blood pressures.	days 3 to 6 of the postpartum period