Back to resultsThe Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy
Primary Purpose
Corneal Dystrophy, Macular Dystrophy, Hyperemesis Gravidarum - Severe
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Optic coherence tomography
Sponsored by
About this trial
This is an interventional health services research trial for Corneal Dystrophy
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
Sites / Locations
- Batman education adn research hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1 ( Hyperemesis gravidarum )
2( Control group)
Arm Description
55 hyperemesis gravidarum patient (11-14th gestational week of pregnancy)
55 healthy pregnant women (11-14th gestational week of pregnancy)
Outcomes
Primary Outcome Measures
Take precautions of the effect of hyperemesis gravidarum on eye health
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05927740
First Posted
June 17, 2023
Last Updated
June 25, 2023
Sponsor
Batman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05927740
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
February 13, 2022 (Actual)
Study Completion Date
May 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Batman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Dystrophy, Macular Dystrophy, Hyperemesis Gravidarum - Severe
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups ( group 1 hyperemesis gravidarum ) (group 2 control group)
Masking
Participant
Masking Description
110
Allocation
Non-Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 ( Hyperemesis gravidarum )
Arm Type
Other
Arm Description
55 hyperemesis gravidarum patient (11-14th gestational week of pregnancy)
Arm Title
2( Control group)
Arm Type
Other
Arm Description
55 healthy pregnant women (11-14th gestational week of pregnancy)
Intervention Type
Diagnostic Test
Intervention Name(s)
Optic coherence tomography
Intervention Description
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 Outcome Measure Information:
Title
Take precautions of the effect of hyperemesis gravidarum on eye health
Description
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.
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)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erhan Okuyan
Organizational Affiliation
Batman Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Batman education adn research hospital
City
Batman
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Available for the journal administrator
Learn more about this trial
The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy
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