NCT05389553

Brief Summary

To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

May 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

May 20, 2022

Last Update Submit

November 23, 2023

Conditions

Keywords

DopplerPregnancyultrasounduterine blood flow

Outcome Measures

Primary Outcomes (1)

  • We estimate the uterine volume and its correlation with the fetal doppler indices

    The volume of the uterine arteries will be measured using a doppler ultrasound. We shall also estimate the fetal doppler indices. Linear regression will be used to test for a possible relationship between uterus volume blood flow and fetal doppler parameters. Before the delivery, all of these variables will be estimated using an ultrasound exam.

    1 day

Study Arms (1)

Patients at term of pregnancy

We included all full-term pregnancies accepted for delivery that received an accurate ultrasound scan before the birth. Pregnant women with antepartum hemorrhage, fetal growth restriction, stillbirths, multiple gestations, or congenital abnormalities were excluded.

Other: Ultrasound exam

Interventions

We included all full-term pregnancies accepted for delivery that received an accurate ultrasound scan before the birth

Patients at term of pregnancy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Full-term pregnancies (37-42 weeks) comprised all pregnant women who would give birth at our hospital.

You may qualify if:

  • full-term pregnancies (37-42 weeks)

You may not qualify if:

  • antepartum hemorrhage, fetal growth restriction, stillbirths, multiple gestations, or congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -

Napoli, Italia, 80138, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 20, 2022

First Posted

May 25, 2022

Study Start

May 30, 2022

Primary Completion

June 30, 2022

Study Completion

October 31, 2023

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations