NCT01174342

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
5 months until next milestone

Results Posted

Study results publicly available

December 27, 2012

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

August 1, 2010

Results QC Date

November 26, 2012

Last Update Submit

January 9, 2013

Conditions

Intraocular PressureDelivery, Obstetric

Keywords

Intraocular pressureOcular tonometryObstetric delivery

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure

    Intraocular pressure during different stages of child delivery.

    During child delivery

Study Arms (1)

Pregnant women

Healthy pregnant women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy women candidate for chlid delivery

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Limitations and Caveats

The number of participants was small due to difficulties in recruitment.

Results Point of Contact

Title
Amit Meshi
Organization
Meir Medical Center
amitmeshi@gmail.com
+972523580222

Study Officials

  • Fani Segev, M.D.

    Meir Medical Center

    STUDY CHAIR

  • Noa Geffen, M.D.

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2010

First Posted

August 3, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 14, 2013

Results First Posted

December 27, 2012

Record last verified: 2013-01

Locations

IL(1)