Pregnancy in DiabeticsNCT03169205
Diabetes Mellitus With Pregnancy in Benisuef Localities
An observational study of Pregnancy in Diabetics, run by Beni-Suef University at 2 sites in Egypt.
Trial summary
The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy in Diabetics
- What is being tested?
- observation registry
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2017to 1 May 2019
- How long will I take part?
- 2 Years
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All pregnant ladies with impaired glucose intolerance either known before or fisrt diagnosed during current pregnancy
Who may be able to join
- all pregnant ladies with Diabetes mellitus either type 1 or type 2
- all pregnant ladies with glucose intolerance which is first diagnosed during current pregnancy
Who cannot join
- ladies age less than 18 year or above 45
Trial locations and contacts
2 sites in 1 country.
About this study
The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes
- Conditions
- Pregnancy in Diabetics
- Being tested
- observation registry
- Medical subject headings
- Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation registryOther
observation registry
| Study group | Role | What they receive |
|---|---|---|
| preexisting Diabetes mellitus type 1 | Not described Receives: Other: observation registry | |
| preexisting Diabetes mellitus type 2 | Not described Receives: Other: observation registry | |
| Gestational Diabetes mellitus | Not described Receives: Other: observation registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal outcome
No. of patients who have preeclampsia,eclampsia,preterm delivery,Cesarean section,vaginal candidiasis,premature rupture of membrane,polyhydramnios,oligohydramnios,accidental hemorrhage,birth canal injuries,puerperal sepsis,wound infection,postpartum glucose intolerance.
Measured: 2 years
Secondary outcomes (1)
fetal outcome
No. of abortion,prematurity,macrosomia,congenital anomalies,intrauterine fetal death,still birth,shoulder dystocia,brachial plexus injury,neonatal death,respiratory distress syndrome,neonatal jaundice requiring photo-therapy,neonatal hypoglycemia,
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 May 2017
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in DiabeticsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momen Zakaria Mohammed mohammed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169205
- Sponsor's protocol ID
- 2500
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 30 May 2017
- 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 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Mellitus With Pregnancy in Benisuef Localities
- ClinicalTrials.gov ID
- NCT03169205
- Acronym / sponsor ID
- 2500
- Conditions
- Pregnancy in Diabetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 30 May 2017 (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.
The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| preexisting Diabetes mellitus type 1 | – | Other: observation registry |
| preexisting Diabetes mellitus type 2 | – | Other: observation registry |
| Gestational Diabetes mellitus | – | Other: observation registry |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pregnant ladies with impaired glucose intolerance either known before or fisrt diagnosed during current pregnancy
Key inclusion criteria (2 listed)
- all pregnant ladies with Diabetes mellitus either type 1 or type 2
- all pregnant ladies with glucose intolerance which is first diagnosed during current pregnancy
Key exclusion criteria (1 listed)
- ladies age less than 18 year or above 45
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 |
|---|---|---|
| observation registryobservation registry | Other | Gestational Diabetes mellitus, preexisting Diabetes mellitus type 1, preexisting Diabetes mellitus type 2 |
Primary outcome
Maternal outcome
Time frame: 2 years
No. of patients who have preeclampsia,eclampsia,preterm delivery,Cesarean section,vaginal candidiasis,premature rupture of membrane,polyhydramnios,oligohydramnios,accidental hemorrhage,birth canal injuries,puerperal sepsis,wound infection,postpartum glucose intolerance.
1 secondary outcome
fetal outcome
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Related trials for Pregnancy in Diabetics
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy in Diabetics, run by Beni-Suef University at 2 sites in Egypt.
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 2 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Maternal outcome (time frame: 2 years). 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 30 May 2017.