BreastfeedingNCT02574494
Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients
An observational study of Breastfeeding and Hypertension, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The primary aim is to establish whether breastfeeding is associated with lowering blood pressure in hypertensive women. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding, Hypertension
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include breastfeeding mothers that have met criteria for hypertension.
Who may be able to join
- 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.
Who cannot join
- The study will exclude patient's on dopamine agonist medications or HIV positive.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
The primary aim is to establish whether breastfeeding is associated with lowering blood pressure in hypertensive women.
Read the detailed description
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.
- Conditions
- Breastfeeding, Hypertension
- Medical subject headings
- Breast Feeding, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in blood pressure after breastfeeding
A decrease of 15mmHg systolic, 10mmHg diastolic, or a decrease of 10% from baseline will be considered significant.
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Kilpatrick, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574494
- Sponsor's protocol ID
- Pro00040747
- Status last verified
- Jan 2019
- First submitted
- 4 Oct 2015
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Breastfeeding Lower Blood Pressure in Postpartum Hypertensive Patients
- ClinicalTrials.gov ID
- NCT02574494
- Acronym / sponsor ID
- Pro00040747
- Conditions
- Breastfeeding, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to establish whether breastfeeding is associated with lowering blood pressure in hypertensive women.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include breastfeeding mothers that have met criteria for hypertension.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The study will exclude patient's on dopamine agonist medications or HIV positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding and Hypertension, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in blood pressure after breastfeeding (time frame: Up to 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.