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

Corneal Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05927740
• Other study ID #: 2020-5
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: May 11, 2023

Study information

• Verified date: June 2023
• Source: Batman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 11, 2023
• Est. primary completion date: February 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria for the study;

• First trimester (8-14 weeks of gestation) pregnancy with positive fetal heartbeat and no history of systemic disease ,

• no history of continuous drug use,

• Diagnosis of hyperemesis gravidarum (ketonuria and weight >3 kg or 5% of the body) The occurrence of >3 vomiting attacks per day with loss of weight,

• Body mass index (BMI) within normal limits,

• Being between the ages of 18-40 ,

• not drinking alcohol or smoking,

• not using any vitamins or supplements use during the study

Exclusion Criteria:

• Any patient who did not meet the inclusion criteria was excluded from the study.

• Patients who participated in the study but later gave up

Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary
• Corneal Dystrophy
• Hyperemesis Gravidarum
• Macular Degeneration
• Macular Dystrophy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Batman education adn research hospital	Batman

Sponsors (1)

Lead Sponsor	Collaborator
Batman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Take precautions of the effect of hyperemesis gravidarum on eye health	The first-line treatment of Hyperemesis gravidarum (HG) patients ( 6 -14 th weeks of pregnant women ) is fluid depletion and antiemetic therapy, but in severe HG, sepsis, thrombosis secondary to parenteral nutrition, and, albeit rare, Wernicke's encephalopathy (WE). This condition (WE), which is defined as a sign of optic disc swelling that causes a diagnostic dilemma in pregnancy, can be diagnosed with a high index of suspicion by clinical signs and radiological evidence, and generally, patients experience rapid improvement in clinical symptoms with intravenous thiamine therapy. For all this reason, it is extremely important to take necessary precautions for obstetricians. Our primary outcome is to compare the macular thickness and corneal thickness of HG patients participating in the study with normal healthy pregnant women using Optic coherancetomography.	Healthy pregnant women and pregnant women diagnosed with Hyperemesis gravidarum between 6-14 weeks; eye examination findings were immediately recorded in the system. (within 1 day)