Delivery, Obstetric, Intraocular Pressure
Conditions
Keywords
Intraocular pressure, Ocular tonometry, Obstetric delivery
Brief summary
The purpose of this study is to evaluate the effect of child delivery on the intraocular pressure in healthy 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.
Interventions
None listed
Sponsors
Meir Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure | During child delivery | Intraocular pressure during different stages of child delivery. |
Countries
Israel
Participant flow
Recruitment details
Healthy pregnant women candidates for vaginal delivery were recruited at their acceptance to the delivery room, between August 2010 and August 2012, in a single center (Meir medical center).
Pre-assignment details
No relevant pre-assignment details exist.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Pregnant Women Healthy pregnant women candidates for vaginal delivery. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Conversion to cesarean section | 4 |
Baseline characteristics
| Characteristic | Healthy Pregnant Women |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age Continuous | 31.5 years STANDARD_DEVIATION 5 |
| Region of Enrollment Israel | 30 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Intraocular Pressure
Intraocular pressure during different stages of child delivery.
Time frame: During child delivery
Population: We included in the analysis all women completing vaginal delivery that had measurements of their intraocular pressure during most stages of labor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Pregnant Women | Intraocular Pressure | Intraocular pressure on admission | 11.8 mm Hg | Standard Deviation 3.6 |
| Healthy Pregnant Women | Intraocular Pressure | Intraocular pressure in Stage 1 latent phase | 11.9 mm Hg | Standard Deviation 3.3 |
| Healthy Pregnant Women | Intraocular Pressure | Intraocular pressure in Stage 1 active phase | 11.8 mm Hg | Standard Deviation 2.9 |
| Healthy Pregnant Women | Intraocular Pressure | Intraocular pressure in Stage 2 | 12.1 mm Hg | Standard Deviation 3.1 |
| Healthy Pregnant Women | Intraocular Pressure | Intraocular pressure in Stage 3 | 12.2 mm Hg | Standard Deviation 4 |
| Healthy Pregnant Women | Intraocular Pressure | Intraocular pressure 24 hours postpartum | 11.9 mm Hg | Standard Deviation 2.4 |
| Healthy Pregnant Women | Intraocular Pressure | Intraocular pressure 48 hours postpartum | 13.2 mm Hg | Standard Deviation 2.3 |