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Effect of Child Delivery on Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT01174342
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : December 27, 2012
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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

Condition or disease
Intraocular Pressure Delivery, Obstetric

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
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Child Delivery on the Intraocular Pressure
Study Start Date : August 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Group/Cohort
Pregnant women
Healthy pregnant women



Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: During child delivery ]
    Intraocular pressure during different stages of child delivery.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy women candidate for chlid delivery
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174342


Locations
Israel
Meir Medical Center
Kfar-Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Study Chair: Fani Segev, M.D. Meir Medical Center
Principal Investigator: Noa Geffen, M.D. Meir Medical Center

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01174342     History of Changes
Other Study ID Numbers: 099-2010mmc
First Posted: August 3, 2010    Key Record Dates
Results First Posted: December 27, 2012
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by Meir Medical Center:
Intraocular pressure
Ocular tonometry
Obstetric delivery