Gestational Diabetes Mellitus With Baby Delivered
Conditions
Brief summary
Study is an interventional clinical trial. Pregnant women (aged 25-40 years) diagnosed with GDM (by a 75-g oral glucose tolerance test at 24-28 weeks' gestation) will be recruited conveniently from Obstetrics and Gynecology clinic at the Jordan University Hospital and National Center for Diabetes, Endocrinology and Genetics, Amman, Jordan. A sample of 180 pregnant women with GDM (60 women who do not use insulin and hypoglycemia medications, 60 women who are treated with metformin, 60 women who are treated with insulin), who will meet the inclusion criteria and will be agreed to participate will be centrally randomized to follow carbohydrate counting dietary intervention, carbohydrate counting and DASH dietary intervention, and control dietary intervention.
Detailed description
The main objective of this study is to compare the effect of carbohydrate counting, carbohydrate counting and DASH diet dietary interventions and a general dietary intervention on glycemic control, maternal and neonatal outcomes among Jordanian pregnant women with GDM. Eligibility criteria to be enrolled in the study will be being Jordanian pregnant women with GDM at 24 -28 gestational weeks, aged between 25 to 40 with no-personal history of type 1 or 2 diabetes, or impaired fasting glucose, or chronic diseases and singleton gestation. DASH diet; and the third group will follow the diet prescribed by the hospital for GDM. The duration of intervention will extend from 24-28 gestational weeks until delivery, which will be usually 12-14 weeks later. The glycemic controls outcomes are testing fasting blood glucose, HbA1C, insulin and fructosamine at baseline and at end of intervention for three dietary interventions. While maternal outcomes are total maternal weight gain (kg), need for emergency caesarean section, the presence or absence of pregnancy-induced hypertension and preeclampsia. The new born birth weight, length and head circumference, the presence or absence of hypoglycemia and shoulder dystocia are the newborn outcomes.
Interventions
BEHAVIORALDietary Intervention
Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Jordanian pregnant women with GDM at 24 -28 gestational weeks. * Aged 25-40 with no-personal history of type 1 or 2 diabetes, or impaired fasting glucose (Koivusalo et al., 2016). * Singleton gestation (Louie et al., 2011). * Absence of chronic diseases such as hypertension, hepatic and kidney disease and cancer, and psychiatric disorder (Ma et al., 2014). * Absence of the use of medication that influences glucose metabolism, such as continuous therapy with oral corticosteroids (Koivusalo et al., 2016) * Pregnant women who do not have special dietary requirements (Louie et al., 2011). Nonsmoker or nonalcoholic drinker during pregnancy (Louie et al., 2011) Well educated and well cooperative, more than 10 years of formal schooling (Ma et al., 2014).
Exclusion criteria
* Non- Jordanian pregnant women or Jordanian pregnant women with GDM at \<24 or \>28 gestational weeks. * Aged \> 40 years with multiple gestation and suspected over-diabetes (Koivusalo et al., 2016). * Multiple gestations (Louie et al., 2011). * Presence of chronic diseases, severe psychiatric disorder. Women with the risk factors for placental insufficiency, or history of preeclampsia (Ma et al., 2014; Koivusalo et al., 2016). * Presence of the use of medication that influences glucose metabolism, such as continuous therapy with oral corticosteroids (Koivusalo et al., 2016) * Pregnant women who have special dietary requirements (Louie et al., 2011). * Who smoked or consumed alcohol during pregnancy (Louie et al., 2011) * Less than 10 years of formal schooling or previous intensive nutrition education or intervention for diabetes (Ma et al., 2014).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose | one year | Fasting blood glucose in mg/dL at 24 -28 weeks of gestation (baseline) and at 36-37) weeks of gestation(endline) of intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting insulin level | one year | Fasting insulin level in µIU/mL at both baseline and endline of intervention. |
| Fructosamine level | one year | fructosamine in µmol/L at both baseline and endline of intervention. |
| Total maternal weight gain | one year | Total maternal weight gain during pregnancy in kilograms |
| Weekly weight gain | one year | weight in kilogram will be measured weekly for all participants |
| Insulin Therapy | one year | Number of participants who need insulin therapy to normalize blood sugar. |
| Emergency caesarean section | one year | Number of participants who need for emergency caesarean section versus vaginal delivery. |
| Hemoglobin A1c level | one year | Hemoglobin A1c% at both baseline and endline of intervention |
| Newborn weight | one year | The newborn weight in grams |
| Newborn Length | one year | The new born length in centimeters. |
| Newborn head circumference | one year | The newborn head circumference in centimeters. |
| Hypoglycemic | one year | Number of newborn babies who will suffer from hypoglycemia |
| Shoulder dystocia | one year | Number of newborn babies with shoulder dystocia. |
| Pregnancy-induced hypertension | one year | Number of participants with existence of hypertension (defined as a blood pressure of at least 140/90 mmHg on two occasions). |
Countries
Jordan
Contacts
Primary ContactSabika S Allehdan, Msc
Backup ContactReema F Tayyem, PhD
Outcome results
None listed