NCT02346214

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

January 20, 2015

Last Update Submit

January 12, 2018

Conditions

Gestational Age

Keywords

Gestational AgeAnterior Lens Capsule VascularityPretermMethod-comparison

Outcome Measures

Primary Outcomes (1)

  • Anterior lens capsule vascularity estimated gestational age

    The gestational age is estimated by eye lens vascularity measurement

    Within 24 hours of delivery

Study Arms (1)

Preterm and term neonates

A. Preterm and term neonates B. Singleton live births between 26 and 42 weeks gestation (determined by first of early-second trimester ultrasound dating) at three referral hospitals

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Singleton live births between 26 and 42 weeks' gestation (determined by first or early-second trimester ultrasound dating)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Loma Linda University Children's Hospital

Loma Linda, California, 92345, United States

Location

University of Iowa Children's Hospital

Iowa City, Iowa, 45542, United States

Location

University of North Carolina at Chapel Hill North Carolina Children's Hospital

Chapel Hill, North Carolina, 27599-2200, United States

Location

Related Publications (8)

  • Altman, D. G. and J. M. Bland (1983).

    BACKGROUND

  • Bland, J. M. and D. G. Altman (2010).

    BACKGROUND

  • Blencowe, H., S. Cousens, D. Chou, M. Oestergaard, L. Say, A.-B. Moller, M. Kinney and J. Lawn (2013).

    BACKGROUND

  • Concato, J., P. Peduzzi, T. R. Holford and A. R. Feinstein (1995). Estrada, R., C. Tomasi, M. T. Cabrera, D. K. Wallace, S. F. Freedman and S. Farsiu (2011).

    BACKGROUND

  • Estrada, R., C. Tomasi, M. T. Cabrera, D. K. Wallace, S. F. Freedman and S. Farsiu (2012).

    BACKGROUND

  • Hittner HM, Gorman WA, Rudolph AJ. Examination of the anterior vascular capsule of the lens: II. Assessment of gestational age in infants small for gestational age. J Pediatr Ophthalmol Strabismus. 1981 Mar-Apr;18(2):52-4. doi: 10.3928/0191-3913-19810301-12.

    PMID: 7195426BACKGROUND

  • Hittner HM, Hirsch NJ, Rudolph AJ. Assessment of gestational age by examination of the anterior vascular capsule of the lens. J Pediatr. 1977 Sep;91(3):455-8. doi: 10.1016/s0022-3476(77)81324-3.

    PMID: 894419BACKGROUND

  • Nagpal J, Kumar A, Ramji S. Anterior lens capsule vascularity in evaluating gestation in small for gestation neonates. Indian Pediatr. 2004 Aug;41(8):817-21.

    PMID: 15347869BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jennifer Griffin, Ph.D. M.P.H.

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 26, 2015

Study Start

July 1, 2016

Primary Completion

November 30, 2017

Study Completion

November 30, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)