Physiologic Change of Posterior Ocular Segment During Pregnancy
1 other identifier
interventional
69
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
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
January 24, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJune 30, 2021
June 1, 2021
4.5 years
January 24, 2021
June 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retinal vascular density
% of retinal vascular density is measured by optical coherence tomography angiography
40 weeks
Secondary Outcomes (3)
Choroidal thickness
40 weeks
Retinal nerve fiber layer thickness
40 weeks
Optic disc tomography
40 weeks
Study Arms (1)
Healthy pregnant women
OTHEROptical coherence tomography and Optical coherence tomography angiography using Optovue® were performed in each trimester and at 6 weeks after childbirth.
Interventions
Optical coherence tomography and optical coherence tomography angiography (Optovue®) were performed in each trimesters and at 6 weeks after childbirth. 1. st trimester : gestational age 8-12 weeks 2. nd trimester : gestational age 24-28 weeks 3. rd trimester : gestational age 34-38 weeks
Eligibility Criteria
You may qualify if:
- Healthy pregnant women
- Age \> 18 years
- Gestational age \< 12 weeks
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Khon Kaen University
Khon Kaen, 40002, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suthasinee Sinawat, MD
KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 24, 2021
First Posted
February 1, 2021
Study Start
July 1, 2021
Primary Completion
December 30, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
June 30, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share