Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT02719886

Conditions

Interval Growth Ultrasound

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Ultrasound

Study Details

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.

Conditions

Interval Growth Ultrasound

Study ID

NCT02719886

Start date

Apr, 2016

Status verified date

Dec, 2016

Primary completion date

Aug, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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 Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

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).

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.

Interventions

Ultrasound

Estimation of fetal weight by ultrasound

Primary outcome measure

  • Frequency of detection of fetal growth abnormalities, starting at 28 weeks gestational age [ Time Frame: up to 72 hours after delivery ]

Central Contacts and Locations

Central contacts

Robyn P Roberts

734-934-4227Robyn.P.Roberts@uth.tmc.edu

Maria Hutchinson

713-500-0510Maria.S.keefer@uth.tmc.edu

Locations

Memorial Hermann Hospital, Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Robyn P Roberts, MD

734-934-4227robyn.p.roberts@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 9, 2016

Last verified

Dec, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2016-12-09.