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

NCT05927740 | Completed

• 1 other identifier: 2020-5
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Corneal Dystrophy; Macular Dystrophy; Hyperemesis Gravidarum - Severe

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

1 ( Hyperemesis gravidarum )

OTHER

55 hyperemesis gravidarum patient (11-14th gestational week of pregnancy)

Diagnostic Test: Optic coherence tomography

2( Control group)

OTHER

55 healthy pregnant women (11-14th gestational week of pregnancy)

Diagnostic Test: Optic coherence tomography

Interventions

Optic coherence tomography DIAGNOSTIC_TEST

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.

1 ( Hyperemesis gravidarum ); 2( Control group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients who participated in the study but later gave up

Sponsors & Collaborators

• Batman Training and Research Hospital: lead

Study Sites (1)

Batman education adn research hospital

Batman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Corneal Dystrophies, Hereditary; Macular Degeneration

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinal Degeneration; Retinal Diseases

Study Officials

• Erhan Okuyan

  Batman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 110
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrics and Gynecology specialist

Model Details: 2 groups ( group 1 hyperemesis gravidarum ) (group 2 control group)

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: July 3, 2023
• Study Start: March 10, 2020
• Primary Completion: February 13, 2022
• Study Completion: May 11, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

TU (1)