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

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).

Study Overview

• Status: Completed
• Conditions: Corneal Dystrophy; Macular Dystrophy; Hyperemesis Gravidarum - Severe
• Intervention / Treatment: Diagnostic test: Optic coherence tomography

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Batman, Turkey
    • Batman education adn research hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1 ( Hyperemesis gravidarum ); 55 hyperemesis gravidarum patient (11-14th gestational week of pregnancy)	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.
Other: 2( Control group); 55 healthy pregnant women (11-14th gestational week of pregnancy)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Batman Training and Research Hospital
• Investigators: Principal Investigator: Erhan Okuyan, Batman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): February 13, 2022
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: June 17, 2023
• First Submitted That Met QC Criteria: June 25, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Signs and Symptoms, Digestive; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Pregnancy Complications; Corneal Diseases; Morning Sickness; Vomiting; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Macular Degeneration; Corneal Dystrophies, Hereditary; Hyperemesis Gravidarum
• Other Study ID Numbers: 2020-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Available for the journal administrator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No