Timing of Serial Ultrasounds (SUN)

Timing of Serial UltrasouNds in High-Risk Pregnancies: A Randomized Controlled Trial

The purpose of this randomized controlled trial is to compare the frequency of the diagnosis of fetal growth abnormalities when ultrasound assessment is performed at 2 versus 4 week intervals.

Study Overview

• Status: Unknown
• Conditions: Interval Growth Ultrasound
• Intervention / Treatment: Device: Ultrasound

Detailed Description

While there is an agreement that women at risk for abnormalities of fetal growth should have serial ultrasound examinations in the 3rd trimester, there is a lack of consensus on how frequently these exams should be done. The American College of Obstetrics and Gynecology recommend that an ultrasound to assess fetal growth be performed between 2 to 4 weeks; however, there have been no prospective or randomized trials to determine whether the optimal interval should be closer to 2 weeks or delayed to 4 weeks. Currently, only 60% of fetuses' with abnormal growth are detected antenatally. There is equipoise of whether ultrasound every 2 versus 4 weeks improves the detection and subsequent newborn outcomes or merely leads to an increase in false positives and unnecessary interventions. It has been proposed, that if delivery occurs within 2 weeks of the ultrasound, the antenatal detection of abnormal growth may be more accurate and hence more likely to improve outcomes. Conversely, a shorter interval may result in confusion as to whether there is actual change in growth or merely variation in the measurement technique itself. Moreover, with the cost of ultrasound averaging approximately $200 per examination, the interval between ultrasounds can have major implications on public-health costs as well as the interventions that subsequently follow if an abnormality is detected.

The purpose of this randomized controlled trial is to compare the frequency of the diagnosis of fetal growth abnormalities when ultrasound assessment is performed at 2 versus 4 week intervals.

• Study Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Hospital, Texas Medical Center
      • Contact: Robyn P Roberts, MD; Phone Number: 734-934-4227; Email: robyn.p.roberts@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Maternal age ≥ 18 years
• Singletons
• Gestational age ≥ 20 weeks to 27 weeks 6 days
• Has insurance, whether private or government issued
• High-risk pregnancy requiring serial fetal growth assessment as determined by the treating physician.
• Dating of pregnancy by ultrasound ≤ 21 weeks and 6 days of gestation or known date of conception in the setting of in vitro fertilization
• No known major anomalies

Exclusion Criteria:

• Known major fetal anomaly
• Multiple gestation (twins or triplets)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fetal growth ultrasound every 2 weeks; Ultrasound to measure fetal growth every 2 weeks (i.e. 28, 30, 32, 34, 36, 38 weeks gestation).	Device: Ultrasound; Estimation of fetal weight by ultrasound
Active Comparator: Fetal growth ultrasound every 4 weeks; Ultrasound to measure fetal growth every 4 weeks (i.e. 28, 32 and 36 weeks gestation). Usual Care.	Device: Ultrasound; Estimation of fetal weight by ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of detection of fetal growth abnormalities, starting at 28 weeks gestational age	up to 72 hours after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birthweight compared to antenatal estimated fetal weights	Comparison of estimated fetal weight by ultrasound to actual birth weight at delivery	At delivery
Frequency of detection of amniotic fluid abnormality, starting at 28 weeks gestational age		Up to 72 hours after delivery
Cost of interventions resulting from detection of abnormal growth or amniotic fluid	e.g. additional ultrasounds, antenatal testing, hospital admission, induction, antepartum or intrapartum complications	up to 72 hours from neonatal discharge from hospital
Composite neonatal morbidity (CNM)		up to 72 hours from neonatal discharge from hospital
Composite maternal morbidity (CMM)		up to 72 hours from mother's discharge from hospital

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-15-0968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO