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NCT01174342 Clinical Trial

Effect of Child Delivery on Intraocular Pressure

Intraocular Pressure Clinical Trial

Official title:
The Effect of Child Delivery on the Intraocular Pressure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01174342
Other study ID # 099-2010mmc
Secondary ID
Status Completed
Phase N/A
First received August 1, 2010
Last updated January 9, 2013
Start date August 2010
Est. completion date August 2012

Study information
Verified date January 2013
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effect of child delivery on the intraocular pressure in healthy women.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Meir Medical Center Kfar-Saba

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular Pressure Intraocular pressure during different stages of child delivery. During child delivery No
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