PregnancyNCT02024048
Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography
An observational study of Pregnancy, run by Gaia Hospital at 1 site in Portugal.
Trial summary
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 Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- OCT
- How many people
- 12 participants
- Where
- 1 sitePortugal
- Study dates
- Dec 2013to Jul 2014
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy pregnant women in the third trimester of pregnancy
Who may be able to join
- 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)
Who cannot join
- any of the above
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova de Gaia
Vila Nova de Gaia
About this study
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
Read the detailed 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.
- Conditions
- Pregnancy
- Being tested
- OCT
- Keywords
- Pregnancy, OCT, Enhanced depth imaging, Choroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTOther
Optical coherence tomography in enhanced depth imaging mode
| Study group | Role | What they receive |
|---|---|---|
| Pregnant | OCT Receives: Other: OCT | |
| Control | OCT Receives: Other: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Comparison of choroidal thickness between the pregnant group of women and the age-matched group of control subjects
Measured: 3rd trimester of pregnancy (from 28 weeks gestation to delivery)
Secondary outcomes (1)
Change in choroidal thickness
Change in choroidal thickness in the third trimester of pregnancy and at 6 months post partum
Measured: During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2014
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Gaia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renata Rothwell, Gaia Hospital
- Investigators
- Renata Rothwell, Dr, Principal investigator, Department of Opthalmolgy, Centro Hospitalar Vila Nova de Gaia/EspinhoSofia Fonseca, Dr, Principal investigator, Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/EspinhoMarisa Oliveira, Dr, Principal investigator, Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/EspinhoLígia Ribeiro, Dr, Principal investigator, Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/EspinhoDália Meira, Dr, Principal investigator, Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024048
- Sponsor's protocol ID
- ECTP-EDI
- Status last verified
- Jan 2014
- First submitted
- 18 Dec 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT02024048
- Acronym / sponsor ID
- ECTP-EDI
- Conditions
- Pregnancy
- Keywords
- Pregnancy, OCT, Enhanced depth imaging, Choroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Gaia HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Not posted in the source record
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 choroidal thickness and volume during the third trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group of women
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant | – | Other: OCTOCT |
| Control | – | Other: OCTOCT |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy pregnant women in the third trimester of pregnancy
Key inclusion criteria (7 listed)
- uncomplicated pregnancy in the third trimester (from 28 weeks of gestation)
- 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)
Key exclusion criteria (1 listed)
- any of the above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCTOptical coherence tomography in enhanced depth imaging mode | Other | Control, Pregnant |
Primary outcome
Choroidal thickness
Time frame: 3rd trimester of pregnancy (from 28 weeks gestation to delivery)
Comparison of choroidal thickness between the pregnant group of women and the age-matched group of control subjects
1 secondary outcome
Change in choroidal thickness
Time frame: During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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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.
Renata Rothwell, Dr principal investigator
Department of Opthalmolgy, Centro Hospitalar Vila Nova de Gaia/Espinho
Sofia Fonseca, Dr principal investigator
Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
Marisa Oliveira, Dr principal investigator
Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
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 Pregnancy, run by Gaia Hospital at 1 site in Portugal.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2014. 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 Portugal. 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?
Results are not available in the source record.
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?
Choroidal thickness (time frame: 3rd trimester of pregnancy (from 28 weeks gestation to delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2014.