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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
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Twin Pregnancy, Antepartum Condition or Complication

Eligibility Criteria

24 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
February 25, 2021
Last Updated
September 2, 2021
Sponsor
Khon Kaen University
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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.

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