Diabetes Mellitus in PregnancyNCT03602846
Diabetes in Pregnancy and Pregnancy Outcomes
An observational study of Diabetes Mellitus in Pregnancy and Diabetes, Gestational, run by Tarumanagara University.
Trial summary
To compare the clinical, glycemic profile and therapy as well as pregnancy complications and infant mortality among diabetic mothers in Indonesia. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus in Pregnancy, Diabetes, Gestational
- What is being tested?
- Medical Nutrition Therapy, Insulin and Oral Antidiabetics
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2016
- 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: Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24.
Who may be able to join
- Clinical and laboratory diagnosis of Diabetes in Pregnancy (Gestational and Pregestational diabetes)
- Mothers must have visited the clinic at least twice throughout their pregnancy, at least one at the first trimester and one at the third trimester
Who cannot join
- Pregnancy is still undergoing
- Incomplete record of glycemic profile, management and fetal outcomes
About this study
Official title: Diabetes in Pregnancy, Therapy and Pregnancy Outcomes
To compare the clinical, glycemic profile and therapy as well as pregnancy complications and infant mortality among diabetic mothers in Indonesia.
Read the detailed description
Pregnancy is a diabetogenic state with increasing burden on the mother's metabolism. Insulin resistance is often found during pregnancy leading to a compensatory increase in pancreatic β-cell response and eventually hyperinsulinemia. Undiagnosed and untreated diabetes in pregnancy have been shown to be linked with numerous comorbidities and complications to both mother and foetus.
This study aims to compare the clinical, glycemic profile along with comorbidities, management and outcomes of diabetic mothers. Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24 were included in this study. The inclusion criteria was all patients with primary diagnosis of O24, have visited the clinic at least twice with a complete record of glycemic profile, management and fetal outcomes.
- Being tested
- Medical Nutrition Therapy, Insulin, Oral Antidiabetics
- Keywords
- diabetes mellitus in pregnancy, gestational diabetes, pregnancy outcomes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Nutrition TherapyDietary supplement
Only given medical nutrition therapy.
InsulinDrug
Prescribed with rapid acting, intermediate acting, mixed or long acting insulin.
Oral AntidiabeticsDrug
Prescribed with all types of oral anti-diabetics.
| Study group | Role | What they receive |
|---|---|---|
| Good Outcome | Good outcome is defined as the safe delivery of the newborn. Receives: Dietary Supplement: Medical Nutrition Therapy; Drug: Insulin; Drug: Oral Antidiabetics | |
| Poor Outcome | Poor outcome is defined as the incidence of fetal demise during pregnancy. Receives: Dietary Supplement: Medical Nutrition Therapy; Drug: Insulin; Drug: Oral Antidiabetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Mortality
Infant Mortality either due to abortion, intrauterine fetal death or stillbirth as recorded in medical records
Measured: Throughout the length of pregnancy, an average of 9 months
Gestational Age at Birth
Infant Gestational at Birth as recorded in medical records
Measured: At time of delivery
Infant Body Weight
Infant Body Weight as recorded in medical records
Measured: At time of delivery
Infant Body Length
Infant Body Length as recorded in medical records
Measured: At time of delivery
Infant Head Circumference
Infant Head Circumference as recorded in medical records
Measured: At time of delivery
APGAR Score
One and five minute APGAR Scores as recorded in medical records
Measured: At time of delivery
Secondary outcomes (3)
Maternal Mortality
Maternal death as recorded in medical records
Measured: Throughout the length of pregnancy, an average of 9 months
Comorbidities
Comorbid conditions were defined as either concomitant hypertension, anemia, urinary tract infection, preeclampsia/eclampsia, or combinations of them as recorded in medical records
Measured: Throughout the length of pregnancy, an average of 9 months
Method of Delivery
Vaginal Birth or Caesarean Section as recorded in medical records
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study startJan 2015
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarumanagara University
- Sponsor type
- University, hospital or other
- Collaborators
- Hermina Podomoro Hospital
- Responsible party
- Principal investigator, Anthony Paulo Sunjaya, Tarumanagara University
- Investigators
- Anthony P Sunjaya, Principal investigator, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602846
- Sponsor's protocol ID
- APS002
- Status last verified
- Jul 2018
- First submitted
- 27 Jun 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes in Pregnancy, Therapy and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT03602846
- Acronym / sponsor ID
- APS002
- Keywords
- diabetes mellitus in pregnancy, gestational diabetes, pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tarumanagara UniversityUniversity, hospital or other
- Collaborators
- Hermina Podomoro Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jul 2018 (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.
To compare the clinical, glycemic profile and therapy as well as pregnancy complications and infant mortality among diabetic mothers in Indonesia.
Detailed description
Pregnancy is a diabetogenic state with increasing burden on the mother's metabolism. Insulin resistance is often found during pregnancy leading to a compensatory increase in pancreatic β-cell response and eventually hyperinsulinemia. Undiagnosed and untreated diabetes in pregnancy have been shown to be linked with numerous comorbidities and complications to both mother and foetus.
This study aims to compare the clinical, glycemic profile along with comorbidities, management and outcomes of diabetic mothers. Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24 were included in this study. The inclusion criteria was all patients with primary diagnosis of O24, have visited the clinic at least twice with a complete record of glycemic profile, management and fetal outcomes.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good Outcome | – | Dietary Supplement: Medical Nutrition Therapy, Drug: Insulin, Drug: Oral AntidiabeticsGood outcome is defined as the safe delivery of the newborn. |
| Poor Outcome | – | Dietary Supplement: Medical Nutrition Therapy, Drug: Insulin, Drug: Oral AntidiabeticsPoor outcome is defined as the incidence of fetal demise during pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant mothers with gestational and pregestational diabetes diagnosed under the ICD-10 coding of O24.
Key inclusion criteria (2 listed)
- Clinical and laboratory diagnosis of Diabetes in Pregnancy (Gestational and Pregestational diabetes)
- Mothers must have visited the clinic at least twice throughout their pregnancy, at least one at the first trimester and one at the third trimester
Key exclusion criteria (2 listed)
- Pregnancy is still undergoing
- Incomplete record of glycemic profile, management and fetal outcomes
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 |
|---|---|---|
| Medical Nutrition TherapyOnly given medical nutrition therapy. | Dietary supplement | Good Outcome, Poor Outcome |
| InsulinPrescribed with rapid acting, intermediate acting, mixed or long acting insulin. | Drug | Good Outcome, Poor Outcome |
| Oral AntidiabeticsPrescribed with all types of oral anti-diabetics. | Drug | Good Outcome, Poor Outcome |
Primary outcome
Infant Mortality
Time frame: Throughout the length of pregnancy, an average of 9 months
Infant Mortality either due to abortion, intrauterine fetal death or stillbirth as recorded in medical records
Gestational Age at Birth
Time frame: At time of delivery
Infant Gestational at Birth as recorded in medical records
Infant Body Weight
Time frame: At time of delivery
Infant Body Weight as recorded in medical records
Infant Body Length
Time frame: At time of delivery
Infant Body Length as recorded in medical records
Infant Head Circumference
Time frame: At time of delivery
Infant Head Circumference as recorded in medical records
APGAR Score
Time frame: At time of delivery
One and five minute APGAR Scores as recorded in medical records
3 secondary outcomes
Maternal Mortality
Time frame: Throughout the length of pregnancy, an average of 9 months
Comorbidities
Time frame: Throughout the length of pregnancy, an average of 9 months
Method of Delivery
Time frame: At time of delivery
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 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Anthony P Sunjaya principal investigator
Tarumanagara University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus in Pregnancy and Diabetes, Gestational, run by Tarumanagara University.
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 2 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Infant Mortality (time frame: Throughout the length of pregnancy, an average of 9 months). The study lists 6 primary outcomes in all. 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 27 Jul 2018.