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

Khon Kaen University

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04773561

HE631549

Details and patient eligibility

About

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 -

Full 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.

Enrollment: 166 estimated patients

Sex: Female

Ages: 24 to 37 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 3 patient groups

multifetal pregnancy in the 3rd trimester

Experimental group

Description:

Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.

Treatment:

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

singleton pregnancy in the 3rd trimester

Active Comparator group

Description:

Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.

Treatment:

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

age-stratified healthy non-pregnant women

Active Comparator group

Description:

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

Treatment:

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