BreastfeedingNCT03701633
Uterine Artery Doppler Changes Prior and After Breastfeeding
An observational study of Breastfeeding, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
We aim to determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Postpartum ultrasound
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2018to 1 Mar 2020
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Every woman who had vaginal delivery, instrumental delivery or cesarean section.
Who may be able to join
- -Every woman who had vaginal delivery, instrumental delivery or cesarean section.
Who cannot join
- -Patient's refusal, women who decided not to breastfeed, women who wish to breastfeed, but in whom no milk production commenced yet.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam health care campus
Haifa
Yaniv Zipori, MD, 0587966963, y_zipori@rambam.health.gov.il
About this study
Official title: Postpartum Uterine Artery Doppler Changes Prior and After Breastfeeding
We aim to determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding.
Read the detailed description
There is emerging evidence linking abnormal UtA Doppler indices in the postpartum period as a risk factor for developing future cardiovascular disorders. Thus far, no study considered the postpartum physiology itself as a possible confounder. If one wishes to draw conclusions about future cardiovascular risk, the role of oxytocin as a confounder must be determined. In the current study, we aim to determine whether oxytocin, physiologically produced during breastfeeding, has an effect on the UtA Doppler measurements in the postpartum period.
- Conditions
- Breastfeeding
- Being tested
- Postpartum ultrasound
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum ultrasoundDiagnostic test
Measurements of the UtA doppler ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session.
| Study group | Role | What they receive |
|---|---|---|
| Prior to breastfeeding - cross section | Measurements of the UtA doppler postpartum ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session. Receives: Diagnostic Test: Postpartum ultrasound | |
| After breastfeeding - cross section | Measurements of the UtA doppler postpartum ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session. Receives: Diagnostic Test: Postpartum ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum uterine artery doppler changes prior and after breastfeeding.
To determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
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.
- 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
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaniv Zipori MD, Rambam Health Care Campus
- Investigators
- Yaniv Zipori, M.D, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701633
- Sponsor's protocol ID
- 0340-17-RMB
- Status last verified
- Dec 2018
- First submitted
- 8 Oct 2018
- Last updated
- 27 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Uterine Artery Doppler Changes Prior and After Breastfeeding
- ClinicalTrials.gov ID
- NCT03701633
- Acronym / sponsor ID
- 0340-17-RMB
- Conditions
- Breastfeeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 10 Oct 2018 (actual)
- 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.
We aim to determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding.
Detailed description
There is emerging evidence linking abnormal UtA Doppler indices in the postpartum period as a risk factor for developing future cardiovascular disorders. Thus far, no study considered the postpartum physiology itself as a possible confounder. If one wishes to draw conclusions about future cardiovascular risk, the role of oxytocin as a confounder must be determined. In the current study, we aim to determine whether oxytocin, physiologically produced during breastfeeding, has an effect on the UtA Doppler measurements in the postpartum period.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior to breastfeeding - cross section | – | Diagnostic Test: Postpartum ultrasoundMeasurements of the UtA doppler postpartum ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session. |
| After breastfeeding - cross section | – | Diagnostic Test: Postpartum ultrasoundMeasurements of the UtA doppler postpartum ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Every woman who had vaginal delivery, instrumental delivery or cesarean section.
Key inclusion criteria (1 listed)
- -Every woman who had vaginal delivery, instrumental delivery or cesarean section.
Key exclusion criteria (1 listed)
- -Patient's refusal, women who decided not to breastfeed, women who wish to breastfeed, but in whom no milk production commenced yet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum ultrasoundMeasurements of the UtA doppler ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session. | Diagnostic test | After breastfeeding - cross section, Prior to breastfeeding - cross section |
Primary outcome
Postpartum uterine artery doppler changes prior and after breastfeeding.
Time frame: One year
To determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
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.
Yaniv Zipori, M.D principal investigator
Rambam Health Care Campus
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, run by Rambam Health Care Campus at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 27 Dec 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaniv Zipori, M.D (+972 58 7966963, y_zipori@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum uterine artery doppler changes prior and after breastfeeding. (time frame: One year). 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 27 Dec 2018.