The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy
NCT ID: NCT05927740
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
110 participants
INTERVENTIONAL
2020-03-10
2023-05-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Retinal and Choroidal Microvascular Changes During Pregnancy Period Detected With Optical Coherence Tomography Angiography
NCT04950855
Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
NCT04773561
Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury
NCT05771467
Measuring Choroidal Thickness Using Optical Coherence Tomography
NCT06272851
Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)
NCT05920655
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1 ( Hyperemesis gravidarum )
55 hyperemesis gravidarum patient (11-14th gestational week of pregnancy)
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.
2( Control group)
55 healthy pregnant women (11-14th gestational week of pregnancy)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patients who participated in the study but later gave up
18 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Batman Training and Research Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Erhan Okuyan,M.D
Obstetrics and Gynecology specialist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Erhan Okuyan
Role: PRINCIPAL_INVESTIGATOR
Batman Training and Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Batman education adn research hospital
Batman, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-5
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.