Twin Pregnancy, Antepartum Condition or ComplicationNCT04773561
Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
A study testing Corneal tomography, optical coherence tomography and optical coherence tomography angiography in people with Twin Pregnancy, Antepartum Condition or Complication and Retinal Vascular, run by Khon Kaen University at 1 site in Thailand.
Trial summary
It has been known that a pregnant women undergoes significant anatomical and physiological changes that mainly caused by hormonal and hematologic changes during pregnancy. Due to advance in reproductive medicine, the incidence of multifetal pregnancy was increased to 3% of livebirth. Read more about this study
- Who is it for?
- Ages 24 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin Pregnancy, Antepartum Condition or Complication, Retinal Vascular, Choroidal Effusion
- What is being tested?
- Corneal tomography, optical coherence tomography and optical coherence tomography angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteThailand
- Study dates
- 3 Sep 2021to 30 Jun 2024
- Phase
- Interventional
- 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 24 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 24-37 years
- 30-36 weeks of gestational age
- clear ocular media
- written informed consent
Who cannot join
- high risk pregnancies such as pre-eclampsia, gestational diabetic mellitus and asthma
- history of refractive error, spherical equivalent > 3 diopters
- history of retinal diseases such as central serous chorioretinopathy and retinal vascular occlusion
- history of intraocular inflammation or endophthalmitis
- history of intraocular laser treatment
- history of intraocular surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
KKU Eye Center, Faculty of Medicine, Khon Kaen University
Phu Wiang, Changwat Khon Kaen, 40002
Suthasinee Sinawat, M.D., 043363010, ssuthasinee@kku.ac.th
About this study
It has been known that a pregnant women undergoes significant anatomical and physiological changes that mainly caused by hormonal and hematologic changes during pregnancy. Due to advance in reproductive medicine, the incidence of multifetal pregnancy was increased to 3% of livebirth. Multifetal pregnancies produce much more physiological changes in the body compared to the singleton pregnancies.
Physiologic ocular changes during pregnancy are the followings
- Melanogenesis of eyelid and facial skin
- Cellular alteration of lacrimal and meibomian gland
- Increased corneal thickness and corneal curvature
- Increased lens thickness
- Increased retinal vascular density
- Increased choroidal thickness Decreased intraocular pressure -
Read the detailed description
From the literature review, there was only on study of ocular changes in twin pregnancies. Alim et al evaluated the choroidal and retinal thickness in singleton versus twin pregnancies. They included 20 single and 20 twin pregnant women in their 3rd trimester with 20-age-matched healthy non-pregnant women as a control group. They found that there was an increase in choroidal thickness in the 3rd trimester of pregnancies and it was prominent in twin pregnancies. There was a statistically significant difference in choroidal thickness between pregnant and non-pregnant women, but not significant difference between singleton and twin pregnancies. The mean retinal nerve fiber layer thickness was significantly higher in the twin pregnancy group than in the singleton pregnancy group. However, no study of retinal vascular density in twin pregnancies has been published before.
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Retinal Vascular, Choroidal Effusion
- Being tested
- Corneal tomography, optical coherence tomography and optical coherence tomography angiography
- Medical subject headings
- Choroidal Effusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal tomography, optical coherence tomography and optical coherence tomography angiographyDevice
Ocular investigations were performed in one time during 30-36 weeks of gestational age. Due to avoidance of diurnal variation, all examinations were done between 10 am - 12 pm.
| Study group | Role | What they receive |
|---|---|---|
| multifetal pregnancy in the 3rd trimester | Experimental | Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age. Receives: Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography |
| singleton pregnancy in the 3rd trimester | Active comparator | Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age. Receives: Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography |
| age-stratified healthy non-pregnant women | Active comparator | Corneal tomography, optical coherence tomography and optical coherence tomography angiography were performed. Receives: Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Choroidal thickness was measured by optical coherence tomography.
Measured: 30-36 weeks of gestational age
Secondary outcomes (3)
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness was measured by optical coherence tomography
Measured: 30-36 weeks of gestational age
Retinal vascular density
Percentage of retinal vascular density was measured by optical coherence tomography angiography
Measured: 30-36 weeks of gestational age
Corneal thickness
Corneal thickness was measured by corneal topography
Measured: 30-36 weeks of gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start3 Sep 2021 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy, Antepartum Condition or ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- age-stratified sample technique (2 age groups: 24-30 years and 31-37 years) ,twin pregnancy:singleton pregnancy:healthy non-pregnant women = 1: 2 : 2
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suthasinee Sinawat, Khon Kaen University
- Investigators
- Suthasinee Sinawat, MD, Principal investigator, KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773561
- Sponsor's protocol ID
- HE631549
- Status last verified
- Sep 2021
- First submitted
- 25 Feb 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Posterior Ocular Changes Between Singleton Pregnancy and Multifetal Pregnancy.
- ClinicalTrials.gov ID
- NCT04773561
- Acronym / sponsor ID
- HE631549
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Retinal Vascular, Choroidal Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 3 Sep 2021 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Feb 2021 (actual)
- 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.
It has been known that a pregnant women undergoes significant anatomical and physiological changes that mainly caused by hormonal and hematologic changes during pregnancy. Due to advance in reproductive medicine, the incidence of multifetal pregnancy was increased to 3% of livebirth. Multifetal pregnancies produce much more physiological changes in the body compared to the singleton pregnancies.
Physiologic ocular changes during pregnancy are the followings
- Melanogenesis of eyelid and facial skin
- Cellular alteration of lacrimal and meibomian gland
- Increased corneal thickness and corneal curvature
- Increased lens thickness
- Increased retinal vascular density
- Increased choroidal thickness Decreased intraocular pressure -
Detailed description
From the literature review, there was only on study of ocular changes in twin pregnancies. Alim et al evaluated the choroidal and retinal thickness in singleton versus twin pregnancies. They included 20 single and 20 twin pregnant women in their 3rd trimester with 20-age-matched healthy non-pregnant women as a control group. They found that there was an increase in choroidal thickness in the 3rd trimester of pregnancies and it was prominent in twin pregnancies. There was a statistically significant difference in choroidal thickness between pregnant and non-pregnant women, but not significant difference between singleton and twin pregnancies. The mean retinal nerve fiber layer thickness was significantly higher in the twin pregnancy group than in the singleton pregnancy group. However, no study of retinal vascular density in twin pregnancies has been published before.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- age-stratified sample technique (2 age groups: 24-30 years and 31-37 years) ,twin pregnancy:singleton pregnancy:healthy non-pregnant women = 1: 2 : 2
| Arm | Type | Receives |
|---|---|---|
| multifetal pregnancy in the 3rd trimester | Experimental | Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiographyCorneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age. |
| singleton pregnancy in the 3rd trimester | Active comparator | Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiographyCorneal tomography, optical coherence tomography and optical coherence tomography angiography were performed in the 3rd trimester, 30-36 weeks of gestational age. |
| age-stratified healthy non-pregnant women | Active comparator | Device: Corneal tomography, optical coherence tomography and optical coherence tomography angiographyCorneal tomography, optical coherence tomography and optical coherence tomography angiography were performed. |
Who may qualify
- Ages
- 24 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 24-37 years
- 30-36 weeks of gestational age
- clear ocular media
- written informed consent
Key exclusion criteria (6 listed)
- high risk pregnancies such as pre-eclampsia, gestational diabetic mellitus and asthma
- history of refractive error, spherical equivalent > 3 diopters
- history of retinal diseases such as central serous chorioretinopathy and retinal vascular occlusion
- history of intraocular inflammation or endophthalmitis
- history of intraocular laser treatment
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 |
|---|---|---|
| Corneal tomography, optical coherence tomography and optical coherence tomography angiographyOcular investigations were performed in one time during 30-36 weeks of gestational age. Due to avoidance of diurnal variation, all examinations were done between 10 am - 12 pm. | Device | age-stratified healthy non-pregnant women, multifetal pregnancy in the 3rd trimester, singleton pregnancy in the 3rd trimester |
Primary outcome
Choroidal thickness
Time frame: 30-36 weeks of gestational age
Choroidal thickness was measured by optical coherence tomography.
3 secondary outcomes
Retinal nerve fiber layer thickness
Time frame: 30-36 weeks of gestational age
Retinal vascular density
Time frame: 30-36 weeks of gestational age
Corneal thickness
Time frame: 30-36 weeks of gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
Suthasinee Sinawat, MD principal investigator
KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal tomography, optical coherence tomography and optical coherence tomography angiography in people with Twin Pregnancy, Antepartum Condition or Complication and Retinal Vascular, run by Khon Kaen University at 1 site in Thailand.
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 4 inclusion and 6 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 5 Sep 2021. 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 Thailand. 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?
Contact Suthasinee Sinawat, MD (+66815454594, ssuthasinee@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal thickness (time frame: 30-36 weeks of gestational age). 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 5 Sep 2021.