Pregnancy in DiabetesNCT02079415
Infants of Diabetic Mothers: A Cohort Study
An observational study of Pregnancy in Diabetes and Fetal Complications, run by Security Forces Hospital at 1 site in Saudi Arabia.
Trial summary
Saudi Arabia has been named by the International Diabetes Federation as among the top ten countries with highest prevalence of diabetes. Women are said to have overall prevalence twice that for men. With high birth rate in the country we decided to look at the impact of diabetic pregnancies on their off-springs Read more about this study
- Who is it for?
- Ages 1 hour and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnancy in Diabetes, Fetal Complications
- What is being tested?
- Prevention of complications in infants of diabetic mothers
- How many people
- 601 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2011to Oct 2012
- 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 1 hour and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All Infants of diabetic mothers born at security Forces Hospital, Riyadh
Who may be able to join
- Infants born to mothers with normal pregnancies
Who cannot join
- Infants born to mothers with other medical disorders before or during pregnancy which may affect the newborn
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Outcome of Infants of Diabetic Mothers in a Tertiary Hospital Set up
Saudi Arabia has been named by the International Diabetes Federation as among the top ten countries with highest prevalence of diabetes. Women are said to have overall prevalence twice that for men. With high birth rate in the country we decided to look at the impact of diabetic pregnancies on their off-springs
Read the detailed description
Diabetics are followed regularly in diabetic outpatient clinics where dietary and medical management are offered. Diabetic pregnancies are managed by a team consisting of diabetologist, obstetrician, feto-maternal obstetrician and dietician.
Management of these pregnancies depends on whether these women have pre-gestational or gestational diabetes. Very few diabetic women have exposure to preconceptual advice. For this reason we opted to find out the outcome of infants of diabetic mothers compared to those mothers who are essentially normal with no associated medical or obstetric disorders. Equally we wanted to see if there are differences in the outcome of infants born to pre-gestational and gestational diabetic mothers.
- Conditions
- Pregnancy in Diabetes, Fetal Complications
- Being tested
- Prevention of complications in infants of diabetic mothers
- Keywords
- NICU
- 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.
Prevention of complications in infants of diabetic mothersOther
Also called Congenital malformations
strict glycemic control in diabetic pregnancies
What is being measured
The primary outcome is the main question the study is designed to answer.
Congenital malformations
Assess presence of congenital malformations in infants of diabetic mothers
Measured: At time of first clinical examination
Secondary outcomes (1)
Length of hospital stay
To assess the length of hospital stay for infants of diabetic mothers
Measured: Until discharge from hospital or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy in DiabetesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Security Forces Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OMER B ABDELBASIT, Security Forces Hospital
- Investigators
- ABEER E LASHEEN, MBBS, Study director, Security Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079415
- Sponsor's protocol ID
- OJS2817
- Status last verified
- May 2015
- First submitted
- 16 Feb 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alqurashi KA, Aljabri KS, Bokhari SA. Prevalence of diabetes mellitus in a Saudi community. Ann Saudi Med. 2011 Jan-Feb;31(1):19-23. doi: 10.4103/0256-4947.75773.
PubMed 21245594Persson M, Norman M, Hanson U. Obstetric and perinatal outcomes in type 1 diabetic pregnancies: A large, population-based study. Diabetes Care. 2009 Nov;32(11):2005-9. doi: 10.2337/dc09-0656. Epub 2009 Aug 12.
PubMed 19675195Yang J, Cummings EA, O'connell C, Jangaard K. Fetal and neonatal outcomes of diabetic pregnancies. Obstet Gynecol. 2006 Sep;108(3 Pt 1):644-50. doi: 10.1097/01.AOG.0000231688.08263.47.
PubMed 16946226
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Outcome of Infants of Diabetic Mothers in a Tertiary Hospital Set up
- ClinicalTrials.gov ID
- NCT02079415
- Acronym / sponsor ID
- OJS2817
- Conditions
- Pregnancy in Diabetes, Fetal Complications
- Keywords
- NICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Security Forces HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Mar 2014 (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.
Saudi Arabia has been named by the International Diabetes Federation as among the top ten countries with highest prevalence of diabetes. Women are said to have overall prevalence twice that for men. With high birth rate in the country we decided to look at the impact of diabetic pregnancies on their off-springs
Detailed description
Diabetics are followed regularly in diabetic outpatient clinics where dietary and medical management are offered. Diabetic pregnancies are managed by a team consisting of diabetologist, obstetrician, feto-maternal obstetrician and dietician.
Management of these pregnancies depends on whether these women have pre-gestational or gestational diabetes. Very few diabetic women have exposure to preconceptual advice. For this reason we opted to find out the outcome of infants of diabetic mothers compared to those mothers who are essentially normal with no associated medical or obstetric disorders. Equally we wanted to see if there are differences in the outcome of infants born to pre-gestational and gestational diabetic mothers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Infants of diabetic mothers born at security Forces Hospital, Riyadh
Key inclusion criteria (1 listed)
- Infants born to mothers with normal pregnancies
Key exclusion criteria (1 listed)
- Infants born to mothers with other medical disorders before or during pregnancy which may affect the newborn
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 |
|---|---|---|
| Prevention of complications in infants of diabetic mothersAlso: Congenital malformationsstrict glycemic control in diabetic pregnancies | Other | – |
Primary outcome
Congenital malformations
Time frame: At time of first clinical examination
Assess presence of congenital malformations in infants of diabetic mothers
1 secondary outcome
Length of hospital stay
Time frame: Until discharge from hospital or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 21245594Alqurashi KA, Aljabri KS, Bokhari SA. Prevalence of diabetes mellitus in a Saudi community. Ann Saudi Med. 2011 Jan-Feb;31(1):19-23. doi: 10.4103/0256-4947.75773.
- Background: PubMed 19675195Persson M, Norman M, Hanson U. Obstetric and perinatal outcomes in type 1 diabetic pregnancies: A large, population-based study. Diabetes Care. 2009 Nov;32(11):2005-9. doi: 10.2337/dc09-0656. Epub 2009 Aug 12.
- Results publication: PubMed 16946226Yang J, Cummings EA, O'connell C, Jangaard K. Fetal and neonatal outcomes of diabetic pregnancies. Obstet Gynecol. 2006 Sep;108(3 Pt 1):644-50. doi: 10.1097/01.AOG.0000231688.08263.47.
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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.
ABEER E LASHEEN, MBBS study director
Security Forces Hospital
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 in Diabetes and Fetal Complications, run by Security Forces Hospital at 1 site in Saudi Arabia.
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: finished, as of the sponsor's last update on 27 May 2015. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Congenital malformations (time frame: At time of first clinical examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02079415, which also lists 3 linked publications.
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 27 May 2015.