NCT03701633

Brief Summary

We aim to determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

December 27, 2018

Status Verified

December 1, 2018

Enrollment Period

11 months

First QC Date

October 8, 2018

Last Update Submit

December 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Study Arms (2)

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

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

Interventions

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.

After breastfeeding - cross sectionPrior to breastfeeding - cross section

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Yaniv Zipori, M.D

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor Yaniv Zipori

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

November 1, 2018

Primary Completion

October 1, 2019

Study Completion

March 1, 2020

Last Updated

December 27, 2018

Record last verified: 2018-12

Locations