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

Not Applicable

Not yet recruiting

• Conditions: Fetal Growth Retardation
• Interventions: Other: Ultrasound following the SMFM guidelines; Other: Ultrasound following the ISUOG guidelines

• Registration Number: NCT05938829
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study Start: 2023-07-01
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Primary Completion: 2025-07-15
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines	Ultrasound following the SMFM 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
Ultrasound using SMFM guidelines, then ultrasound using ISUOG guidelines	Ultrasound following the 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

Primary Outcome Measures

Name	Time	Method
Number of neonates who have composite neonatal adverse outcomes (CNAO)	from time of birth to 30 days after birth

Secondary Outcome Measures

Name	Time	Method
Number of participants that need mechanical ventilation	6 hours after birth
Number of cesarean deliveries	at the time of delivery
Number of participants that are admitted to neonatal intensive care unit (NICU)	from time of birth to 30 days after birth
Number of participants for whom there was a deviation from the management protocol	from time of diagnosis of fetal growth restriction to delivery
Number of mothers who have composite maternal adverse outcomes (CMAO)	from time of birth to 30 days after birth	This includes estimated blood loss (EBL) / quantitative blood loss (QBL) \> 1,000 mL, Transfusion, chorioamnionitis, ICU admission, or Maternal death
Number of participants with Apgar score < 7	at 5 minutes after birth
Number of participants that have culture-proven neonatal sepsis	from time of birth to 30 days after birth
Number of participants that are still born or show neonatal death	from time of birth to 30 days after birth
Number of participants that show signs of neonatal seizure	from time of birth to 30 days after birth
Number of participants that have intracranial hemorrhage	from time of birth to 30 days after birth

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States