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Effect of Child Delivery on Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01174342
First received: August 1, 2010
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition
Intraocular Pressure
Delivery, Obstetric

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Child Delivery on the Intraocular Pressure

Resource links provided by NLM:

MedlinePlus related topics: Childbirth
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: During child delivery ] [ Designated as safety issue: No ]
    Intraocular pressure during different stages of child delivery.


Enrollment: 30
Study Start Date: August 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant women
Healthy pregnant women

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01174342     History of Changes
Other Study ID Numbers: 099-2010mmc
Study First Received: August 1, 2010
Results First Received: November 26, 2012
Last Updated: January 9, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 16, 2013