Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-01 @ 9:30 AM
Study NCT ID:
NCT04773561
Status:
UNKNOWN
Last Update Posted:
2021-09-05
First Post:
2021-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
Sponsor:
Khon Kaen University
Organization:
Study Overview
Official Title:
Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It has been known that a pregnant women undergoes significant anatomical and physiological changes that mainly caused by hormonal and hematologic changes during pregnancy. Due to advance in reproductive medicine, the incidence of multifetal pregnancy was increased to 3% of livebirth. Multifetal pregnancies produce much more physiological changes in the body compared to the singleton pregnancies.
Physiologic ocular changes during pregnancy are the followings
* Melanogenesis of eyelid and facial skin
* Cellular alteration of lacrimal and meibomian gland
* Increased corneal thickness and corneal curvature
* Increased lens thickness
* Increased retinal vascular density
* Increased choroidal thickness Decreased intraocular pressure -
Physiologic ocular changes during pregnancy are the followings
* Melanogenesis of eyelid and facial skin
* Cellular alteration of lacrimal and meibomian gland
* Increased corneal thickness and corneal curvature
* Increased lens thickness
* Increased retinal vascular density
* Increased choroidal thickness Decreased intraocular pressure -
Detailed Description:
From the literature review, there was only on study of ocular changes in twin pregnancies. Alim et al evaluated the choroidal and retinal thickness in singleton versus twin pregnancies. They included 20 single and 20 twin pregnant women in their 3rd trimester with 20-age-matched healthy non-pregnant women as a control group. They found that there was an increase in choroidal thickness in the 3rd trimester of pregnancies and it was prominent in twin pregnancies. There was a statistically significant difference in choroidal thickness between pregnant and non-pregnant women, but not significant difference between singleton and twin pregnancies. The mean retinal nerve fiber layer thickness was significantly higher in the twin pregnancy group than in the singleton pregnancy group. However, no study of retinal vascular density in twin pregnancies has been published before.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: