NCT02154945

Brief Summary

Purpose: Primary: to prospectively measure Retinal Nerve Fiber Layer (RNFL) and macular thickness changes during pregnancy by Optical coherence tomography Secondary: The effect of pregnancy abnormalities on RNFL and macular thickness in participants who develop systemic or ocular complications during the study period.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 13, 2016

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

May 28, 2014

Last Update Submit

January 12, 2016

Conditions

PregnancyRetinal Nerve Fiber Layer ThicknessMacular Thickness

Outcome Measures

Primary Outcomes (1)

  • Retinal nerve fiber layer(RNFL) and Macular thickness by Optical coherence tomography(OCT) during pregnancy

    The RNFL, measured in micrometers, will be followed up during the study. Every trimester (starting at the 1st trimester) an OCT will be performed measuring the thickness of the RNFL. An OCT will be performed 3 months postpartum as a control. The Macular thickness will be measured in the same manner.

    1 year

Secondary Outcomes (1)

  • Effect of systemic and ocular diseases on Retinal Fiber Layer and Macula during pregnancy

    1 year

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant patients

You may qualify if:

  • st trimester (6-14w) pregnant healthy women
  • No known medical problems related to their current pregnancy on recruitment
  • Age 18-45yrs
  • No known retinal or optic nerve disease
  • Refraction between +3.0 and -4.0 diopters
  • Agrees to participate in the study

You may not qualify if:

  • Retinal or optic nerve disease
  • Refractive errors more than +3.0 and -4.0.
  • If already finished 14w gestation when recruited to the 1st OCT examination
  • Known to have HTN or DM before gestation
  • Ocular media abnormality that obscures OCT view or examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baruch Padeh Medical Center

Poria – Neve Oved, Lower Galeli, 15208, Israel

Location

Study Officials

  • Nakhoul Fa Nakhoul, MD

    Baruch Padeh Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2014

First Posted

June 4, 2014

Study Start

January 1, 2016

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 13, 2016

Record last verified: 2014-06

Locations

IL(1)