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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04731415
Other study ID # HE631577
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date June 30, 2026

Study information

Verified date June 2021
Source Khon Kaen University
Contact Suthasinee Sinawat, MD
Phone +66 81 5454594
Email ssuthasinee@kku.ac.th
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 69
Est. completion date June 30, 2026
Est. primary completion date December 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Thailand Khon Kaen University Khon Kaen

Sponsors (1)

Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal vascular density % of retinal vascular density is measured by optical coherence tomography angiography 40 weeks
Secondary Choroidal thickness Choroidal thickness (um) is measured by optical coherence tomography 40 weeks
Secondary Retinal nerve fiber layer thickness Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography 40 weeks
Secondary Optic disc tomography Cup area and disc area (mm3) are measured by optical coherence tomography 40 weeks
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