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

Retinal Vascular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04773561
• Other study ID #: HE631549
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2021
• Source: Khon Kaen University
• Contact: Suthasinee Sinawat, MD
• Phone: +66815454594
• Email: ssuthasinee[@]kku.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 -

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 24 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Effusion
• Obstetric Labor Complications
• Retinal Vascular
• Twin Pregnancy, Antepartum Condition or Complication

Intervention

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.

Locations

Country	Name	City	State
Thailand	KKU Eye Center, Faculty of Medicine, Khon Kaen University	Nai Muang	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal thickness	Choroidal thickness was measured by optical coherence tomography.	30-36 weeks of gestational age
Secondary	Retinal nerve fiber layer thickness	Retinal nerve fiber layer thickness was measured by optical coherence tomography	30-36 weeks of gestational age
Secondary	Retinal vascular density	Percentage of retinal vascular density was measured by optical coherence tomography angiography	30-36 weeks of gestational age
Secondary	Corneal thickness	Corneal thickness was measured by corneal topography	30-36 weeks of gestational age