Uterine Artery Doppler Changes Prior and After Breastfeeding

Breastfeeding Clinical Trial

Official title:

Postpartum Uterine Artery Doppler Changes Prior and After Breastfeeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03701633
• Other study ID #: 0340-17-RMB
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2018
• Source: Rambam Health Care Campus
• Contact: Yaniv Zipori, M.D
• Phone: +972 58 7966963
• Email: y_zipori[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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