NCT03244579

Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes

Studying the Effectiveness of Carbohydrate Counting and Dietary Approach to Stop Hypertension Dietary Intervention on Glycemic Control and Maternal and Newborn Health Outcomes Among Jordanian Pregnant Women With Gestational Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: University of Jordan · Academic / Other
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gestational Diabetes Mellitus With Baby Delivered

Interventions

Type	Name	Description
BEHAVIORAL	Dietary Intervention	Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.

Timeline

• Start date: 2017-08-20
• Primary completion: 2019-08-20
• Completion: 2019-10-20
• First posted: 2017-08-09
• Last updated: 2018-11-26

Locations

1 site across 1 country: Jordan