Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04773561
Enrollment
166
Registered
2021-02-26
Start date
2021-09-03
Completion date
2024-06-30
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICECorneal 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.

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

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

Eligibility

Sex/Gender
FEMALE
Age
24 Years to 37 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Choroidal thickness30-36 weeks of gestational ageChoroidal thickness was measured by optical coherence tomography.

Secondary

MeasureTime frameDescription
Retinal nerve fiber layer thickness30-36 weeks of gestational ageRetinal nerve fiber layer thickness was measured by optical coherence tomography
Retinal vascular density30-36 weeks of gestational agePercentage of retinal vascular density was measured by optical coherence tomography angiography
Corneal thickness30-36 weeks of gestational ageCorneal thickness was measured by corneal topography

Countries

Thailand

Contacts

Primary ContactSuthasinee Sinawat, MD
ssuthasinee@kku.ac.th+66815454594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026