This trial is active, not recruiting.

Condition pregnancy
Treatment oct
Sponsor Gaia Hospital
Start date December 2013
End date January 2014
Trial size 12 participants
Trial identifier NCT02024048, ECTP-EDI


The purpose of this study is to evaluate choroidal thickness and volume during the third trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group of women

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Optical coherence tomography in enhanced depth imaging mode
Optical coherence tomography in enhanced depth imaging mode

Primary Outcomes

Choroidal thickness
time frame: 3rd trimester of pregnancy (from 28 weeks gestation to delivery)

Secondary Outcomes

Change in choroidal thickness
time frame: During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: Pregnant women: - uncomplicated pregnancy in the third trimester (from 28 weeks of gestation) For both groups: - no systemic or ocular disease - absence of systemic medication other than prenatal vitamins - no smoking habits - emmetropia or a small refractive error (spherical equivalent <1.5 diopters) Exclusion Criteria: - any of the above

Additional Information

Official title Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography
Principal investigator Renata Rothwell, Dr
Description Pregnant women in the last trimester and age-matched healthy controls have an Optical Coherence Tomography (OCT) image taken on the OCT Spectralis® device. A map of the choroid in the macular area is constructed automatically. Choroidal thickness and volume are calculated for the 9 subfields defined by the Early Treatment Diabetic Retinopathy Study (ETDRS). A comparative analysis between the two groups will be performed. As a secondary outcome measure, the change in choroidal thickness of the pregnant group of women will be assessed at 6 months postpartum by comparison to the 3rd trimester of pregnancy. The OCT is a non-invasive examination that poses no risk to the mother or the fetus.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Gaia Hospital.