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

Not Applicable

• Conditions: Twin Pregnancy, Antepartum Condition or Complication; Choroidal Effusion; Retinal Vascular
• Interventions: Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography

• Registration Number: NCT04773561
• Lead Sponsor: Khon Kaen University

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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-02-26
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Study Start: 2021-09-03
• Last Update Posted: 2021-09-05
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 166

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
singleton pregnancy in the 3rd trimester	Corneal tomography, optical coherence tomography and optical coherence tomography angiography	Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.
multifetal pregnancy in the 3rd trimester	Corneal tomography, optical coherence tomography and optical coherence tomography angiography	Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.
age-stratified healthy non-pregnant women	Corneal tomography, optical coherence tomography and optical coherence tomography angiography	Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed.

Primary Outcome Measures

Name	Time	Method
Choroidal thickness	30-36 weeks of gestational age	Choroidal thickness was measured by optical coherence tomography.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

KKU Eye Center, Faculty of Medicine, Khon Kaen University; 🇹🇭 Nai Muang, Khon Kaen, Thailand