Uterine Artery Doppler Changes

Uterine Artery Flow Clinical Trial

Official title:

Uterine Artery Doppler Changes From the Second Trimester of Pregnancy to the Postpartum Period in a Group of High Risk Women

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03064698
• Other study ID #: 16-035
• Status: Enrolling by invitation
• Start date: September 1, 2017
• Est. completion date: September 1, 2022

Study information

• Verified date: October 2020
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In uncomplicated pregnancies, the uterine spiral arteries undergo a series of structural changes that result in a low resistance in the uterine arteries as pregnancy progresses.

In many pregnancies complicated with preeclampsia, growth restriction and other placental related complication, the described change does not occur. In pregnancies at high risk for placental complications, doppler measurement of Uterine artery flow has been shown to be a reliable predictor of complications.

Postpartum there is a reversal of vascular changes seen in normal pregnancies. It is unclear if there is a full reversal of these changes in complicated pregnancies with abnormal flow during pregnancy.

The investigators hypothesize that Doppler uterine artery measurements after complicated pregnancies will show some abnormality compared to doppler measurements following uncomplicated pregnancies.

Description:

The postpartum reversal of pregnancy-related changes in uterine artery (UA) flow is not well documented.

While long-term vascular changes have been noted in women with prior preeclampsia (PE), and in a dose- dependent manner, long-term changes to UA vascular resistance following PE have not been analyzed. Moreover, regardless of whether they experienced PE or intrauterine growth restriction (IUGR), it is not known if women with elevated UA pulsatility index (PI) in mid-pregnancy have higher UA well after pregnancy, compared to women whose UA PI was normal in mid-pregnancy.

The investigators propose to evaluate if UA flow remains abnormally high postpartum in women who had elevated UA flow mid-pregnancy, compared to women whose UA flow was normal in mid-pregnancy.

This is an observational prospective study. The study recruits women that have recently delivered and have undergone a Uterine Doppler ultra sound (US) during the second trimester of their pregnancy. Eligible women will undergo one post-partum ultrasound examination.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 32
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women who underwent UA Doppler assessment at 18-22 weeks gestation.

• Viable singleton pregnancy at the time of UA Doppler assessment at 18-22 weeks gestation.

• Is at least 6 weeks postpartum following a livebirth of the aforementioned pregnancy

• Not pregnant at time of post-partum UA Doppler assessment

Exclusion Criteria:

• Women will be excluded if they do not meet the above criteria

Related Conditions & MeSH terms

• Uterine Artery Flow

Intervention

Other:
• Post-partum Doppler ultrasound
Participants will undergo one uterine artery Doppler ultrasound at 6 weeks post-partum.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in uterine artery flow	Uterine artery flow measurements during pregnancy and after, as measured by Doppler ultrasound	2nd trimester (between 13 to 22 weeks gestation) and 6 weeks post-partum