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

• Sponsor: Khon Kaen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04773561
• Collaborator: (none)
• Enrollment: 166
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 33.9
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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 -

Condition or Disease	Intervention/Treatment	Phase
Twin Pregnancy, Antepartum Condition or Complication; Retinal Vascular; Choroidal Effusion	Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 166 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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 : 2age-stratified sample technique (2 age groups: 24-30 years and 31-37 years) ,twin pregnancy:singleton pregnancy:healthy non-pregnant women = 1: 2 : 2
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
• Anticipated Study Start Date: Sep 3, 2021
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: multifetal pregnancy in the 3rd trimester Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.	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.
Active Comparator: singleton pregnancy in the 3rd trimester Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age.	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.
Active Comparator: age-stratified healthy non-pregnant women Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed.	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.

Outcome Measures

Primary Outcome Measures

1. Choroidal thickness [30-36 weeks of gestational age]

   Choroidal thickness was measured by optical coherence tomography.

Secondary Outcome Measures

1. Retinal nerve fiber layer thickness [30-36 weeks of gestational age]

   Retinal nerve fiber layer thickness was measured by optical coherence tomography

2. Retinal vascular density [30-36 weeks of gestational age]

   Percentage of retinal vascular density was measured by optical coherence tomography angiography

3. Corneal thickness [30-36 weeks of gestational age]

   Corneal thickness was measured by corneal topography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Years to 37 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KKU Eye Center, Faculty of Medicine, Khon Kaen University	Nai Muang	Khon Kaen	Thailand	40002

Sponsors and Collaborators

• Khon Kaen University

Investigators

• Principal Investigator: Suthasinee Sinawat, MD, KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suthasinee Sinawat, Associate Professor, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT04773561
• Other Study ID Numbers: HE631549
• First Posted: Feb 26, 2021
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Choroidal Effusions

Study Results

No Results Posted as of Sep 5, 2021