Intraocular PressureNCT01174342

Effect of Child Delivery on Intraocular Pressure

An observational study of Intraocular Pressure and Delivery, Obstetric, run by Meir Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Intraocular Pressure, Delivery, Obstetric
How many people: 30 participants
Where: 1 siteIsrael
Study dates: Aug 2010to Aug 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Study population: Healthy women candidate for chlid delivery

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

Meir Medical Center
Kfar Saba

Other trials in Israel

About this study

Official title: 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.

Read the 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.

Conditions: Intraocular Pressure, Delivery, Obstetric
Keywords: Intraocular pressure, Ocular tonometry, Obstetric delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01174342
Study group	Role	What they receive
Pregnant women		Healthy pregnant women

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure
Intraocular pressure during different stages of child delivery.
Measured: During child delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Aug 2012

First posted3 Aug 2010 (estimated)
Study startAug 2010
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Intraocular PressureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01174342
Sponsor's protocol ID: 099-2010mmc
Status last verified: Jan 2013
First submitted: 1 Aug 2010
Last updated: 14 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intraocular Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Child Delivery on the Intraocular Pressure
ClinicalTrials.gov ID: NCT01174342
Acronym / sponsor ID: 099-2010mmc
Conditions: Intraocular Pressure, Delivery, Obstetric
Keywords: Intraocular pressure, Ocular tonometry, Obstetric delivery
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Meir Medical CenterUniversity, hospital or other
Study start: Aug 2010
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 3 Aug 2010 (estimated)
Results: Posted 27 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pregnant women	–	–Healthy pregnant women

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Healthy women candidate for chlid delivery

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Intraocular Pressure
Time frame: During child delivery
Intraocular pressure during different stages of child delivery.

Results and safety

Results posted to the registry on 27 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Pregnant Women	30	26

Primary outcome: Intraocular Pressure

Time frame: During child delivery. Mean (Standard Deviation). Unit: mm Hg

Measure	Healthy Pregnant Women n = 26
Intraocular pressure on admission	11.8 (3.6)
Intraocular pressure in Stage 1 latent phase	11.9 (3.3)
Intraocular pressure in Stage 1 active phase	11.8 (2.9)
Intraocular pressure in Stage 2	12.1 (3.1)
Intraocular pressure in Stage 3	12.2 (4)
Intraocular pressure 24 hours postpartum	11.9 (2.4)
Intraocular pressure 48 hours postpartum	13.2 (2.3)

Population analysed: We included in the analysis all women completing vaginal delivery that had measurements of their intraocular pressure during most stages of labor.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Pregnant Women	0 of 30 (0%)	0 of 30 (0%)	Not reported

Limitations and caveats (from the sponsor): The number of participants was small due to difficulties in recruitment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Intraocular Pressure

Active, not recruiting
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Automated Applanation Tonometry - Updated
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RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fani Segev, M.D. study chair

Meir Medical Center

Noa Geffen, M.D. principal investigator

Meir Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Intraocular Pressure and Delivery, Obstetric, run by Meir Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular Pressure (time frame: During child delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01174342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.