Clinical trial NCT04773561: Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
Official title: Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Twin Pregnancy, Antepartum Condition or Complication
Retinal Vascular
Choroidal Effusion
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 166
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Choroidal thickness
timeFrame: 30-36 weeks of gestational age
Secondary outcomes:
measure: Retinal nerve fiber layer thickness
timeFrame: 30-36 weeks of gestational age
measure: Retinal vascular density
timeFrame: 30-36 weeks of gestational age
measure: Corneal thickness
timeFrame: 30-36 weeks of gestational age
Other outcomes:
Locations:
city: Nai Muang
country: Thailand
facility: KKU Eye Center, Faculty of Medicine, Khon Kaen University
state: Khon Kaen
Study officials:
affiliation: KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
name: Suthasinee Sinawat, MD
role: PRINCIPAL_INVESTIGATOR
References: