Timing of Serial Ultrasounds
SUN
Timing of Serial UltrasouNds in High-Risk Pregnancies: A Randomized Controlled Trial
1 other identifier
interventional
228
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
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
February 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedDecember 9, 2016
December 1, 2016
1.3 years
February 11, 2016
December 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of detection of fetal growth abnormalities, starting at 28 weeks gestational age
up to 72 hours after delivery
Secondary Outcomes (5)
Birthweight compared to antenatal estimated fetal weights
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
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
Study Arms (2)
Fetal growth ultrasound every 2 weeks
EXPERIMENTALUltrasound to measure fetal growth every 2 weeks (i.e. 28, 30, 32, 34, 36, 38 weeks gestation).
Fetal growth ultrasound every 4 weeks
ACTIVE COMPARATORUltrasound to measure fetal growth every 4 weeks (i.e. 28, 32 and 36 weeks gestation). Usual Care.
Interventions
Estimation of fetal weight by ultrasound
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known major fetal anomaly
- Multiple gestation (twins or triplets)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Hermann Hospital, Texas Medical Center
Houston, Texas, 77030, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow
Study Record Dates
First Submitted
February 11, 2016
First Posted
March 25, 2016
Study Start
April 1, 2016
Primary Completion
August 1, 2017
Last Updated
December 9, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share