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OpenTrials
Completed

NCT Number: NCT02574494

Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients

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

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Cardiovascular Diseases Feeding Behavior Hypertension Vascular Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

Patients included in this study will have chosen to breastfeed.

  • 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.
  • 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.
  • Only hypertensive women will be included. Hypertension is defined as persistent Systolic blood pressure > 140 and or persistent diastolic blood pressure > 90.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Other outcomes

  1. Blood pressure measurement

    Time frame: Up to 16 months

    Blood pressure will be measured using millimeters of mercury (mmHg).

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2015
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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