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Completed

NCT Number: NCT05927740

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).

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Batman education adn research hospital

Batman, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Take precautions of the effect of hyperemesis gravidarum on eye health

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Batman Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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