Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients

Hypertension Clinical Trial

Official title:

Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574494
• Other study ID #: Pro00040747
• Status: Completed
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary aim is to establish whether breastfeeding is associated with lowering blood pressure in hypertensive women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding
• Hypertension
• Hypotension

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure measurement	Blood pressure will be measured using millimeters of mercury (mmHg).	Up to 16 months
Primary	Decrease in blood pressure after breastfeeding	A decrease of 15mmHg systolic, 10mmHg diastolic, or a decrease of 10% from baseline will be considered significant.	Up to 16 months