Fetal Growth Restriction: Management Using Two Guidelines - Fetal Growth Antenatal Management Evaluation

NCT ID: NCT05938829

Last Updated: 2023-07-11

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-01

Brief Summary

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The purpose of this study is to compare the composite neonatal adverse outcomes (CNAO) among pregnancies complicated by fetal growth restriction (FGR) managed using the Society of Maternal-Fetal Medicine (SMFM) versus International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) antepartum ultrasound guidelines, to measure the rate of the individual components of CNAO, to record the rate of cesarean delivery during labor, to tabulate the rate of deviation from the management protocol assigned at the time of evaluation, to record neonatal intensive care unit (NICU) admission rates and to measure the rate of the composite maternal adverse outcome (CMAO).

Detailed Description

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Conditions

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Fetal Growth Retardation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines

Each site will utilize SMFM guidelines for the first 12 months and then there will be a 2 week washout period, after which each site will utilize ISUOG guidelines for 12 months

Group Type OTHER

Ultrasound following the SMFM guidelines

Intervention Type OTHER

Patients will be followed with weekly ultrasound. During these scans, the patient will have a biophysical profile, a non-stress test (if the gestational age is over 32 weeks), and a Doppler interrogation of the fetal umbilical artery. This information will be captured in our ultrasound reporting software, Viewpoint.

Ultrasound following the ISUOG guidelines

Intervention Type OTHER

Patients will be followed with weekly ultrasound. During these scans, the patient will have a biophysical profile, a non-stress test (if the gestational age is over 32 weeks), and a Doppler interrogation of the fetal umbilical artery, middle cerebral artery, and ductus venosus. This information will be captured in our ultrasound reporting software, Viewpoint.

Interventions

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Ultrasound following the SMFM guidelines

Patients will be followed with weekly ultrasound. During these scans, the patient will have a biophysical profile, a non-stress test (if the gestational age is over 32 weeks), and a Doppler interrogation of the fetal umbilical artery. This information will be captured in our ultrasound reporting software, Viewpoint.

Intervention Type OTHER

Ultrasound following the ISUOG guidelines

Patients will be followed with weekly ultrasound. During these scans, the patient will have a biophysical profile, a non-stress test (if the gestational age is over 32 weeks), and a Doppler interrogation of the fetal umbilical artery, middle cerebral artery, and ductus venosus. This information will be captured in our ultrasound reporting software, Viewpoint.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* FGR diagnosed during sonographic examinations
* estimated fetal weight less than or a fetal abdominal circumference less than the 10th percentile

Exclusion Criteria

* Multiple gestations with FGR
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Hector Mendez-Figueroa

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hector Mendez-Figueroa, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Hector Mendez-Figueroa, MD

Role: CONTACT

713-566-4674

Sunbola S Ashimi Ademola

Role: CONTACT

713-500-6410

Facility Contacts

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Hector Mendez-Figueroa, MD

Role: primary

713-566-4674

Sunbola S Ashimi Ademola

Role: backup

713-500-6410

Other Identifiers

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2023-2012

Identifier Type: -

Identifier Source: org_study_id

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