Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
Primary Purpose
Twin Pregnancy, Antepartum Condition or Complication, Retinal Vascular, Choroidal Effusion
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Corneal tomography, optical coherence tomography and optical coherence tomography angiography
Sponsored by
About this trial
This is an interventional other trial for Twin Pregnancy, Antepartum Condition or Complication
Eligibility Criteria
Inclusion Criteria:
- 24-37 years
- 30-36 weeks of gestational age
- clear ocular media
- written informed consent
Exclusion Criteria:
- high risk pregnancies such as pre-eclampsia, gestational diabetic mellitus and asthma
- history of refractive error, spherical equivalent > 3 diopters
- history of retinal diseases such as central serous chorioretinopathy and retinal vascular occlusion
- history of intraocular inflammation or endophthalmitis
- history of intraocular laser treatment
- history of intraocular surgery
Sites / Locations
- KKU Eye Center, Faculty of Medicine, Khon Kaen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
multifetal pregnancy in the 3rd trimester
singleton pregnancy in the 3rd trimester
age-stratified healthy non-pregnant women
Arm Description
Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.
Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.
Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed.
Outcomes
Primary Outcome Measures
Choroidal thickness
Choroidal thickness was measured by optical coherence tomography.
Secondary Outcome Measures
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness was measured by optical coherence tomography
Retinal vascular density
Percentage of retinal vascular density was measured by optical coherence tomography angiography
Corneal thickness
Corneal thickness was measured by corneal topography
Full Information
NCT ID
NCT04773561
First Posted
February 25, 2021
Last Updated
September 2, 2021
Sponsor
Khon Kaen University
1. Study Identification
Unique Protocol Identification Number
NCT04773561
Brief Title
Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
Official Title
Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2021 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 -
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin Pregnancy, Antepartum Condition or Complication, Retinal Vascular, Choroidal Effusion
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
age-stratified sample technique (2 age groups: 24-30 years and 31-37 years)
,twin pregnancy:singleton pregnancy:healthy non-pregnant women = 1: 2 : 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
multifetal pregnancy in the 3rd trimester
Arm Type
Experimental
Arm Description
Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.
Arm Title
singleton pregnancy in the 3rd trimester
Arm Type
Active Comparator
Arm Description
Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.
Arm Title
age-stratified healthy non-pregnant women
Arm Type
Active Comparator
Arm Description
Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed.
Intervention Type
Device
Intervention Name(s)
Corneal tomography, optical coherence tomography and optical coherence tomography angiography
Intervention Description
Ocular investigations were performed in one time during 30-36 weeks of gestational age. Due to avoidance of diurnal variation, all examinations were done between 10 am - 12 pm.
Primary Outcome Measure Information:
Title
Choroidal thickness
Description
Choroidal thickness was measured by optical coherence tomography.
Time Frame
30-36 weeks of gestational age
Secondary Outcome Measure Information:
Title
Retinal nerve fiber layer thickness
Description
Retinal nerve fiber layer thickness was measured by optical coherence tomography
Time Frame
30-36 weeks of gestational age
Title
Retinal vascular density
Description
Percentage of retinal vascular density was measured by optical coherence tomography angiography
Time Frame
30-36 weeks of gestational age
Title
Corneal thickness
Description
Corneal thickness was measured by corneal topography
Time Frame
30-36 weeks of gestational age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
24-37 years
30-36 weeks of gestational age
clear ocular media
written informed consent
Exclusion Criteria:
high risk pregnancies such as pre-eclampsia, gestational diabetic mellitus and asthma
history of refractive error, spherical equivalent > 3 diopters
history of retinal diseases such as central serous chorioretinopathy and retinal vascular occlusion
history of intraocular inflammation or endophthalmitis
history of intraocular laser treatment
history of intraocular surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suthasinee Sinawat, MD
Phone
+66815454594
Email
ssuthasinee@kku.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suthasinee Sinawat, MD
Organizational Affiliation
KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KKU Eye Center, Faculty of Medicine, Khon Kaen University
City
Nai Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suthasinee Sinawat, M.D.
Phone
043363010
Email
ssuthasinee@kku.ac.th
12. IPD Sharing Statement
Learn more about this trial
Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
We'll reach out to this number within 24 hrs