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

Sponsor
Batman Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05927740
Collaborator
(none)
110
1
2
38
2.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Optic coherence tomography
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2 groups ( group 1 hyperemesis gravidarum ) (group 2 control group)2 groups ( group 1 hyperemesis gravidarum ) (group 2 control group)
Masking:
Single (Participant)
Masking Description:
110
Primary Purpose:
Health Services Research
Official Title:
The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy
Actual Study Start Date :
Mar 10, 2020
Actual Primary Completion Date :
Feb 13, 2022
Actual Study Completion Date :
May 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 1 ( Hyperemesis gravidarum )

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

Diagnostic Test: 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.

Other: 2( Control group)

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

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Batman education adn research hospital Batman Turkey

Sponsors and Collaborators

  • Batman Training and Research Hospital

Investigators

  • Principal Investigator: Erhan Okuyan, Batman Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erhan Okuyan,M.D, Obstetrics and Gynecology specialist, Batman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05927740
Other Study ID Numbers:
  • 2020-5
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 3, 2023