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

Batman Training and Research Hospital

Status: Completed

Conditions: Macular Dystrophy; Hyperemesis Gravidarum - Severe; Corneal Dystrophy

Treatments: Diagnostic Test: Optic coherence tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT05927740

2020-5

Details and patient eligibility

About

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).

Full 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.

Enrollment: 110 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

1 ( Hyperemesis gravidarum )

Other group

Description:

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

Treatment:

Diagnostic Test: Optic coherence tomography

2( Control group)

Other group

Description:

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

Treatment:

Diagnostic Test: Optic coherence tomography