Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.

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 -

Study Overview

• Status: Recruiting
• Conditions: Retinal Vascular; Twin Pregnancy, Antepartum Condition or Complication; Choroidal Effusion
• Intervention / Treatment: Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography

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 Type: Interventional
• Enrollment (Anticipated): 166
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suthasinee Sinawat, MD; Phone Number: +66815454594; Email: ssuthasinee@kku.ac.th

Study Locations

• Thailand
  • Khon Kaen
    • Nai Muang, Khon Kaen, Thailand, 40002
      • Recruiting
      • KKU Eye Center, Faculty of Medicine, Khon Kaen University
      • Contact: Suthasinee Sinawat, M.D.; Phone Number: 043363010; Email: ssuthasinee@kku.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 37 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multifetal pregnancy in the 3rd trimester; Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.	Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography; 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.
Active Comparator: singleton pregnancy in the 3rd trimester; Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.	Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography; 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.
Active Comparator: age-stratified healthy non-pregnant women; Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed.	Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choroidal thickness	Choroidal thickness was measured by optical coherence tomography.	30-36 weeks of gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal nerve fiber layer thickness	Retinal nerve fiber layer thickness was measured by optical coherence tomography	30-36 weeks of gestational age
Retinal vascular density	Percentage of retinal vascular density was measured by optical coherence tomography angiography	30-36 weeks of gestational age
Corneal thickness	Corneal thickness was measured by corneal topography	30-36 weeks of gestational age

Collaborators and Investigators

• Sponsor: Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 3, 2021
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eye Abnormalities; Uveal Diseases; Choroid Diseases; Choroidal Effusions
• Other Study ID Numbers: HE631549

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No