Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients

January 31, 2019 updated by: Sarah Kilpatrick, Cedars-Sinai Medical Center
The primary aim is to establish whether breastfeeding is associated with lowering blood pressure in hypertensive women.

Study Overview

Status

Completed

Detailed Description

Patients included in this study will have chosen to breastfeed.

  1. The investigators will identify patients that are planning to breastfeed from their intake questionnaire that all patients receive upon admission to labor and delivery. They will also identify breastfeeding patients while performing our postpartum rounding.
  2. The investigators will perform a chart review to determine their co-morbidities and current medications. Specifically, the patient information recorded will be age, parity, gestational age, delivery route, vital signs, medications, race, whether they are breastfeeding. Of note, all of the individuals listed to participate in this study have routine access to the patient's charts since they will be working with the patients regardless of their participation in the study.
  3. Only hypertensive women will be included. Hypertension is defined as persistent Systolic blood pressure > 140 and or persistent diastolic blood pressure > 90.
  4. Once it has been determined that they have met the inclusion criteria for the study the investigators will ask the patient's attending physician if we can approach the patient and explain the study and obtain consent.
  5. Once consent is obtained, the investigators will inform the nurse. The patient will have her blood pressure taken prior to breastfeeding, during breastfeeding, and 1-2 hours after breastfeeding. This will occur 3 times in the postpartum period.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population will include breastfeeding mothers that have met criteria for hypertension.

Description

Inclusion Criteria:

  • The inclusion criteria include hypertensive women in the first 72 hours postpartum. The gestational age at delivery must be greater or equal to 34wk and the patient must be breastfeeding and/or pumping milk. The study will include patient's on anti-hypertensive. The study will also include patients receiving postpartum IV magnesium but they will have their blood pressure taken two times while on magnesium and two times after the magnesium has been discontinued.

Exclusion Criteria:

  • The study will exclude patient's on dopamine agonist medications or HIV positive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in blood pressure after breastfeeding
Time Frame: Up to 16 months
A decrease of 15mmHg systolic, 10mmHg diastolic, or a decrease of 10% from baseline will be considered significant.
Up to 16 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure measurement
Time Frame: Up to 16 months
Blood pressure will be measured using millimeters of mercury (mmHg).
Up to 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 4, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00040747

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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