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

September 2, 2021 updated by: Suthasinee Sinawat, Khon Kaen University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Khon Kaen
      • Nai Muang, Khon Kaen, Thailand, 40002
        • Recruiting
        • KKU Eye Center, Faculty of Medicine, Khon Kaen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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