Trial Outcomes & Findings for Effect of Child Delivery on Intraocular Pressure (NCT NCT01174342)

NCT ID: NCT01174342

Last Updated: 2013-01-14

Results Overview

Intraocular pressure during different stages of child delivery.

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: During child delivery
• Results posted on: 2013-01-14

Participant Flow

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).

No relevant pre-assignment details exist.

Participant milestones

Measure	Healthy Pregnant Women Healthy pregnant women candidates for vaginal delivery.
Overall Study STARTED	30
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Healthy Pregnant Women Healthy pregnant women candidates for vaginal delivery.
Overall Study Conversion to cesarean section	4

Baseline Characteristics

Effect of Child Delivery on Intraocular Pressure

Baseline characteristics by cohort

Measure	Healthy Pregnant Women n=30 Participants Healthy pregnant women candidates for vaginal delivery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	31.5 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Israel	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Intraocular pressure during different stages of child delivery.

Outcome measures

Measure	Healthy Pregnant Women n=26 Participants Healthy pregnant women candidates for vaginal delivery
Intraocular Pressure Intraocular pressure on admission	11.8 mm Hg Standard Deviation 3.6
Intraocular Pressure Intraocular pressure in Stage 1 latent phase	11.9 mm Hg Standard Deviation 3.3
Intraocular Pressure Intraocular pressure in Stage 1 active phase	11.8 mm Hg Standard Deviation 2.9
Intraocular Pressure Intraocular pressure in Stage 2	12.1 mm Hg Standard Deviation 3.1
Intraocular Pressure Intraocular pressure in Stage 3	12.2 mm Hg Standard Deviation 4
Intraocular Pressure Intraocular pressure 24 hours postpartum	11.9 mm Hg Standard Deviation 2.4
Intraocular Pressure Intraocular pressure 48 hours postpartum	13.2 mm Hg Standard Deviation 2.3

Adverse Events

Healthy Pregnant Women

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amit Meshi

Meir Medical Center

Phone: +972523580222

Email: amitmeshi@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place