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

NCT ID: NCT04773561

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2024-06-30

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Corneal tomography, optical coherence tomography and optical coherence tomography angiography

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Corneal tomography, optical coherence tomography and optical coherence tomography angiography

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Corneal tomography, optical coherence tomography and optical coherence tomography angiography

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 24 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Suthasinee Sinawat

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suthasinee Sinawat, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

KKU Eye Center, Faculty of Medicine, Khon Kaen University

Phu Wiang, Changwat Khon Kaen, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Suthasinee Sinawat, MD

Role: CONTACT

ssuthasinee@kku.ac.th

+66815454594

Facility Contacts

Suthasinee Sinawat, M.D.

Role: primary

ssuthasinee@kku.ac.th

043363010

Other Identifiers

HE631549

Identifier Type: -

Identifier Source: org_study_id