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Uterine Artery Doppler Changes Prior and After Breastfeeding

NCT ID: NCT03701633

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-03-01

Brief Summary

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

Detailed Description

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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

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Breastfeeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Postpartum ultrasound

Intervention Type DIAGNOSTIC_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 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.

Postpartum ultrasound

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Yaniv Zipori MD

Doctor Yaniv Zipori

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaniv Zipori, M.D

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam health care campus

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yaniv Zipori, M.D

Role: CONTACT

Phone: +972 58 7966963

Email: [email protected]

Facility Contacts

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Yaniv Zipori, MD

Role: primary

Other Identifiers

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0340-17-RMB

Identifier Type: -

Identifier Source: org_study_id