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Timing of Serial Ultrasounds

NCT ID: NCT02719886

Last Updated: 2016-12-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Interval Growth Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Fetal growth ultrasound every 2 weeks

Ultrasound to measure fetal growth every 2 weeks (i.e. 28, 30, 32, 34, 36, 38 weeks gestation).

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Estimation of fetal weight by ultrasound

Fetal growth ultrasound every 4 weeks

Ultrasound to measure fetal growth every 4 weeks (i.e. 28, 32 and 36 weeks gestation). Usual Care.

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type DEVICE

Estimation of fetal weight by ultrasound

Interventions

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Ultrasound

Estimation of fetal weight by ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Robyn Roberts

Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Memorial Hermann Hospital, Texas Medical Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robyn P Roberts

Role: CONTACT

Phone: 734-934-4227

Email: [email protected]

Maria Hutchinson

Role: CONTACT

Phone: 713-500-0510

Email: [email protected]

Facility Contacts

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Robyn P Roberts, MD

Role: primary

Other Identifiers

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HSC-MS-15-0968

Identifier Type: -

Identifier Source: org_study_id