Physiologic Change of Posterior Ocular Segment During Pregnancy

Women's physiology changes markedly during normal pregnancy. The most distinct alterations occur in the hormonal and cardiovascular systems. There is a dramatic increase in both estrogen and progesterone. Blood volume starts to increase in the first gestational period and reaches a peak in the third trimester.

The physiologic ocular changes during pregnancy are mainly the result of hormonal and blood volume increase, and then are usually marked in the third trimester.

Study Overview

• Status: Not yet recruiting
• Conditions: Retinal Vascular
• Intervention / Treatment: Device: Optical coherence tomography and optical coherence tomography angiography (Optovue®)

Detailed Description

Ocular anterior segment changes during pregnancy are the followings

• Melanogenesis of eyelid and facial skin -> melasma
• Cellular alteration of lacrimal and meibomian gland -> dry eye symptoms
• Increased corneal thickness and corneal curvature -> contact lens intolerance
• Increased lens thickness -> loss of accommodation
• Decreased intraocular pressure -> better glaucoma control There are few studies of posterior changes in pregnant women. Many limitations of previous publications includes lack of internal control and no data of postpartum contraception. However, choroidal thickness seems to be thicker in pregnant women than non-pregnant women. The other changes are non-inclusive.

• Study Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy pregnant women
• Age > 18 years
• Gestational age < 12 weeks
• Written informed consent

Exclusion Criteria:

• High risk pregnancy such as multifetal pregnancy and preeclampsia
• History of vitreoretinal diseases such as retinal vasculitis
• History of intraocular laser treatments or intraocular surgeries
• History of systemic diseases such as diabetes mellitus and thyroid disease
• Refractive error; spherical equivalence > 4 diopters
• Clear ocular media
• Could not be taken the images by non-dilated pupil

Withdrawal Criteria:

• Preterm labor; gestational age < 34 weeks
• Multifetal pregnancy was demonstrated by ultrasound
• Severe labor and delivery complications such as
• Severe postpartum complications such as postpartum bleeding
• Taking hormone during the follow-up period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Healthy pregnant women; Optical coherence tomography and Optical coherence tomography angiography using Optovue® were performed in each trimester and at 6 weeks after childbirth.	Device: Optical coherence tomography and optical coherence tomography angiography (Optovue®); Optical coherence tomography and optical coherence tomography angiography (Optovue®) were performed in each trimesters and at 6 weeks after childbirth.; st trimester : gestational age 8-12 weeks; nd trimester : gestational age 24-28 weeks; rd trimester : gestational age 34-38 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal vascular density	% of retinal vascular density is measured by optical coherence tomography angiography	40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal nerve fiber layer thickness	Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography	40 weeks
Choroidal thickness	Choroidal thickness (um) is measured by optical coherence tomography	40 weeks
Optic disc tomography	Cup area and disc area (mm3) are measured by optical coherence tomography	40 weeks

Collaborators and Investigators

• Sponsor: Khon Kaen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2021
• Primary Completion (ANTICIPATED): December 30, 2025
• Study Completion (ANTICIPATED): June 30, 2026

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (ACTUAL): February 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Optical coherence tomography angiography; Retinal nerve fiber layer thickness; Choroidal thickness; Retinal vascular density; Optic nerve head
• Other Study ID Numbers: HE631577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No