Smartphone Ophthalmoscope of Lens Vascularity to Estimate Gestational Age
Completed
Conditions studied: Gestational Age
In brief
The purpose of this study is to develop a novel, highly automated method of gestational age estimation at delivery combining anterior lens capsule vascularity (ALCV) and biophysical parameters appropriate for use in low income countries. The specific aims of the proposed study are: (1) To develop an algorithm to predict gestational age at delivery from 26 to 42 weeks' gestation with ALCV and key biophysical parameters (2)To evaluate the performance of ALCV and biophysical parameter-based gestational age estimates. Specifically, we hypothesize that the accuracy of the predictive algorithm will be comparable to commonly used measures of gestational age dating (±2 days) and have better precision (±14 days) than commonly used measures of gestational age dating.
Key facts
- Study ID
- NCT02346214
- Run by
- RTI International
- People needed
- 252
- Starts
- 2016-07-01
- Expected to finish
- 2017-11-30
- Last updated by the study team
- 2018-01-17
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Gestational age 260/7 to 426/7 weeks (based on antenatal ultrasound <20 weeks gestation)
- Chronological age <24 hours
- Consent of the patient's parents or legal guardians
You may not qualify if…
- Fused eyelids
- Corneal opacity or cataract
- Obstetrical ultrasound performed at <20 weeks' gestation not performed/not available
- Known genetic/congenital anomalies
- Known coagulopathies
- Patients who, in the opinion of the attending physician or clinical study staff, are too medically unstable to participate in the study safely
Where it is running
- Loma Linda University Children's Hospital — Loma Linda, California, United States
- University of Iowa Children's Hospital — Iowa City, Iowa, United States
- University of North Carolina at Chapel Hill North Carolina Children's Hospital — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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