NCT05927740

The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Batman Training and Research Hospital · Other Government
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Aim Physiological changes in intraocular pressure as well as in the cornea and macula may occur during pregnancy. In the literature, there are limited data on ocular findings in hyperemesis gravidarum. Therefore, we have decided to investigate the effect of hyperemesis gravidarum on macular thickness, corneal thickness and intraocular pressure (IOP).

Detailed description

A total of 110 people, 55 of whom were diagnosed with hyperemesis gravidarum and 55 of whom were in the control group, were included in the study. The inclusion criteria for the study were as follows: First trimester (8-14 weeks of gestation) pregnancy with positive fetal heartbeat and no history of systemic disease; no continuous use of medication; diagnosis of hyperemesis gravidarum (ketonuria and weight \> 3 kg or 5% of the body) and the occurrence of less than three vomiting attacks per day with loss of weight; body mass index (BMI) within normal limits; being between the ages of 18 and 40; not drinking alcohol or smoking. A total of 94 patients, 40 of whom were diagnosed with hyperemesis gravidarum and 54 healthy pregnant women, were divided into two groups by recording their age, BMI, laboratory and eye findings.

Conditions

• Corneal Dystrophy
• Macular Dystrophy
• Hyperemesis Gravidarum - Severe

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Optic coherence tomography	Every participant was subjected to a comprehensive ophthalmologic examination which included measuring auto-refraction (average of three values, Topcon Autorefractometer model KM 8900, Japan), uncorrected visual acuity with cycloplegic refraction (with 0.5% cyclopentolate HCl), and IOP in millimeters of mercury (mmHg, Goldmann applanation tonometer). Moreover, slit-lamp biomicroscopy (HaagStreit, Bern, Switzerland) was performed, concentrating on potential corneal scarring and/or lenticular opacities.

Timeline

• Start date: 2020-03-10
• Primary completion: 2022-02-13
• Completion: 2023-05-11
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: Turkey (Türkiye)