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

NCT04773561 | Unknown DMC

• 1 other identifier: HE631549
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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 -

Conditions

Twin Pregnancy, Antepartum Condition or Complication; Retinal Vascular; Choroidal Effusion

Outcome Measures

Primary Outcomes (1)

• Choroidal thickness

  Choroidal thickness was measured by optical coherence tomography.

  30-36 weeks of gestational age

Secondary Outcomes (3)

• Retinal nerve fiber layer thickness

  30-36 weeks of gestational age

• Retinal vascular density

  30-36 weeks of gestational age

• Corneal thickness

  30-36 weeks of gestational age

Study Arms (3)

multifetal pregnancy in the 3rd trimester

EXPERIMENTAL

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

singleton pregnancy in the 3rd trimester

ACTIVE COMPARATOR

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

age-stratified healthy non-pregnant women

ACTIVE COMPARATOR

Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed.

Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography

Interventions

Corneal tomography, optical coherence tomography and optical coherence tomography angiography DEVICE

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.

age-stratified healthy non-pregnant women; multifetal pregnancy in the 3rd trimester; singleton pregnancy in the 3rd trimester

Eligibility Criteria

• Age: 24 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• weeks of gestational age
• clear ocular media
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

KKU Eye Center, Faculty of Medicine, Khon Kaen University

Phu Wiang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Choroidal Effusions

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Choroid Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Suthasinee Sinawat, MD

  KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suthasinee Sinawat, MD

CONTACT

+66815454594; ssuthasinee@kku.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: February 26, 2021
• Study Start: September 3, 2021
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

TH (1)