Clinical trial NCT05927740: The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy
Official title: The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Dystrophy
Macular Dystrophy
Hyperemesis Gravidarum - Severe
Lead sponsor: Batman Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-03
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups ( group 1 hyperemesis gravidarum ) (group 2 control group)
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Take precautions of the effect of hyperemesis gravidarum on eye health
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman education adn research hospital
Study officials:
affiliation: Batman Training and Research Hospital
name: Erhan Okuyan
role: PRINCIPAL_INVESTIGATOR
References: