Uterine Artery Doppler Changes Prior and After Breastfeeding

December 25, 2018 updated by: Yaniv Zipori MD, Rambam Health Care Campus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

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

  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam Health Care Campus

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

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Every woman who had vaginal delivery, instrumental delivery or cesarean section.

Description

Inclusion Criteria:

-Every woman who had vaginal delivery, instrumental delivery or cesarean section.

Exclusion Criteria:

-Patient's refusal, women who decided not to breastfeed, women who wish to breastfeed, but in whom no milk production commenced yet.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Postpartum ultrasound
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.
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.
Diagnostic test: Postpartum ultrasound
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

Investigators

  • Principal Investigator: Yaniv Zipori, M.D, Rambam Health Care Campus

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 (Actual)

November 1, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 10, 2018

Study Record Updates

Last Update Posted (Actual)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 25, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 0340-17-RMB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Breastfeeding

Clinical Trials on Postpartum ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe