Clinical trial NCT02719886: Timing of Serial Ultrasounds
Official title: Timing of Serial UltrasouNds in High-Risk Pregnancies: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interval Growth Ultrasound
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Frequency of detection of fetal growth abnormalities, starting at 28 weeks gestational age
timeFrame: up to 72 hours after delivery
Secondary outcomes:
measure: Birthweight compared to antenatal estimated fetal weights
timeFrame: At delivery
measure: Frequency of detection of amniotic fluid abnormality, starting at 28 weeks gestational age
timeFrame: Up to 72 hours after delivery
measure: Cost of interventions resulting from detection of abnormal growth or amniotic fluid
timeFrame: up to 72 hours from neonatal discharge from hospital
measure: Composite neonatal morbidity (CNM)
timeFrame: up to 72 hours from neonatal discharge from hospital
measure: Composite maternal morbidity (CMM)
timeFrame: up to 72 hours from mother's discharge from hospital
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital, Texas Medical Center
state: Texas
Study officials:
References: