- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01174342
Effect of Child Delivery on Intraocular Pressure
January 9, 2013 updated by: Meir Medical Center
The Effect of Child Delivery on the Intraocular Pressure
The purpose of this study is to evaluate the effect of child delivery on the intraocular pressure in healthy women.
Study Overview
Status
Completed
Conditions
Detailed Description
Little is known about the changes in intraocular pressure (IOP) during child delivery.
During labor there are several stages which are accompanied by many physiological changes and pharmacological interventions that may potentially influence the IOP.
Among these are delivery position (lying versus sitting or kneeling), vascular changes and pharmacological effects (anesthetic agents, oxytocin and other drugs).
The purpose of this study is to evaluate the effect of child delivery on the intraocular pressure (IOP) in healthy women.
This will expend our understanding of the physiology of labor and its effect on the eye and it may serve as basis to determine the management of labor.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kfar-Saba, Israel
- Meir Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Healthy women candidate for chlid delivery
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Pregnant women admitted to the labor room.
- Healthy women that do not take any systemic medications.
- No known ocular condition, except for refraction errors, strabismus or amblyopia.
- Eligible women who are able to sign an informed consent form.
Exclusion Criteria:
- Family history of glaucoma (first degree relatives).
- Known allergic reaction to local anesthesia (oxybuprocaine hydrochloride).
- Women who are unable to sign an informed consent form.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Pregnant women
Healthy pregnant women
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraocular Pressure
Time Frame: During child delivery
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Intraocular pressure during different stages of child delivery.
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During child delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Fani Segev, M.D., Meir Medical Center
- Principal Investigator: Noa Geffen, M.D., Meir Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
August 1, 2010
First Submitted That Met QC Criteria
August 2, 2010
First Posted (Estimate)
August 3, 2010
Study Record Updates
Last Update Posted (Estimate)
January 14, 2013
Last Update Submitted That Met QC Criteria
January 9, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 099-2010mmc
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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