Physiologic Change of Posterior Ocular Segment During Pregnancy

NCT ID: NCT04731415

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2026-06-30

Brief Summary

Women's physiology changes markedly during normal pregnancy. The most distinct alterations occur in the hormonal and cardiovascular systems. There is a dramatic increase in both estrogen and progesterone. Blood volume starts to increase in the first gestational period and reaches a peak in the third trimester.

The physiologic ocular changes during pregnancy are mainly the result of hormonal and blood volume increase, and then are usually marked in the third trimester.

Detailed Description

Ocular anterior segment changes during pregnancy are the followings

• Melanogenesis of eyelid and facial skin -> melasma
• Cellular alteration of lacrimal and meibomian gland -> dry eye symptoms
• Increased corneal thickness and corneal curvature -> contact lens intolerance
• Increased lens thickness -> loss of accommodation
• Decreased intraocular pressure -> better glaucoma control There are few studies of posterior changes in pregnant women. Many limitations of previous publications includes lack of internal control and no data of postpartum contraception. However, choroidal thickness seems to be thicker in pregnant women than non-pregnant women. The other changes are non-inclusive.

Conditions

Retinal Vascular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy pregnant women

Optical coherence tomography and Optical coherence tomography angiography using Optovue® were performed in each trimester and at 6 weeks after childbirth.

Group Type: OTHER

Optical coherence tomography and optical coherence tomography angiography (Optovue®)

Intervention Type: DEVICE

Optical coherence tomography and optical coherence tomography angiography (Optovue®) were performed in each trimesters and at 6 weeks after childbirth.

1. st trimester : gestational age 8-12 weeks

2. nd trimester : gestational age 24-28 weeks

3. rd trimester : gestational age 34-38 weeks

Interventions

Optical coherence tomography and optical coherence tomography angiography (Optovue®)

Optical coherence tomography and optical coherence tomography angiography (Optovue®) were performed in each trimesters and at 6 weeks after childbirth.

1. st trimester : gestational age 8-12 weeks

2. nd trimester : gestational age 24-28 weeks

3. rd trimester : gestational age 34-38 weeks

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy pregnant women
• Age > 18 years
• Gestational age < 12 weeks
• Written informed consent

Exclusion Criteria

• High risk pregnancy such as multifetal pregnancy and preeclampsia
• History of vitreoretinal diseases such as retinal vasculitis
• History of intraocular laser treatments or intraocular surgeries
• History of systemic diseases such as diabetes mellitus and thyroid disease
• Refractive error; spherical equivalence > 4 diopters
• Clear ocular media
• Could not be taken the images by non-dilated pupil

Withdrawal Criteria:

• Preterm labor; gestational age < 34 weeks
• Multifetal pregnancy was demonstrated by ultrasound
• Severe labor and delivery complications such as
• Severe postpartum complications such as postpartum bleeding
• Taking hormone during the follow-up period

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Suthasinee Sinawat

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suthasinee Sinawat, MD

Role: PRINCIPAL_INVESTIGATOR

KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Locations

Khon Kaen University

Khon Kaen, , Thailand

Countries

Thailand

Central Contacts

Suthasinee Sinawat, MD

Role: CONTACT

ssuthasinee@kku.ac.th

+66 81 5454594

Other Identifiers

HE631577

Identifier Type: -

Identifier Source: org_study_id