Diabetes in PregnancyPhase 2NCT04129190
Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
A Phase 2 study testing Glucose in people with Diabetes in Pregnancy, run by Isra University at 1 site in Pakistan.
Trial summary
With the increasing prevalence of diabetes in pregnancy it is necessary to design a simple, sensitive, cost effective method for screening of hyperglycaemia in pregnancy specially in resource constrained settings. There is no universally agreed screening and diagnostic criteria to detect hyperglycemia in pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes in Pregnancy
- What is being tested?
- Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2019to 15 Jan 2020
- Phase
- Phase 2
- 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
Who may be able to join
- All pregnant women
Who cannot join
- Known diabetic
Trial locations and contacts
1 site in 1 country.
About this study
With the increasing prevalence of diabetes in pregnancy it is necessary to design a simple, sensitive, cost effective method for screening of hyperglycaemia in pregnancy specially in resource constrained settings.
There is no universally agreed screening and diagnostic criteria to detect hyperglycemia in pregnancy. In present study, DIPSI (non-fasting OGTT) is compared with fasting oral glucose tolerance test (OGTT) to evaluate sensitivity and specificity of both methods in our population.
- Conditions
- Diabetes in Pregnancy
- Being tested
- Glucose
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseBiological
Oral Intake of Glucose
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Not described Receives: Biological: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Glucose Tolerance
Measurement of Plasma Glucose after intake of 75 gram oral glucose
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start15 Oct 2019 (estimated)
- Primary completion15 Jan 2020 (estimated)
- Study completion15 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes in 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr shabeen, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129190
- Sponsor's protocol ID
- IsraU
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Non-fasting OGTT Versus Fasting OGTT for Screening of Hyperglycaemia in Pregnancy (HIP)
- ClinicalTrials.gov ID
- NCT04129190
- Acronym / sponsor ID
- IsraU
- Conditions
- Diabetes in Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 15 Jan 2020 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 16 Oct 2019 (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.
With the increasing prevalence of diabetes in pregnancy it is necessary to design a simple, sensitive, cost effective method for screening of hyperglycaemia in pregnancy specially in resource constrained settings.
There is no universally agreed screening and diagnostic criteria to detect hyperglycemia in pregnancy. In present study, DIPSI (non-fasting OGTT) is compared with fasting oral glucose tolerance test (OGTT) to evaluate sensitivity and specificity of both methods in our population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Biological: Glucose |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant women
Key exclusion criteria (1 listed)
- Known diabetic
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 |
|---|---|---|
| GlucoseOral Intake of Glucose | Biological | Single |
Primary outcome
Oral Glucose Tolerance
Time frame: 2 hours
Measurement of Plasma Glucose after intake of 75 gram oral glucose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glucose in people with Diabetes in Pregnancy, run by Isra University at 1 site in Pakistan.
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 1 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 16 Oct 2019. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Oral Glucose Tolerance (time frame: 2 hours). 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 16 Oct 2019.