Randomized Controlled Trial of Psyllium Fiber Supplementation to Reduce Medication Need in Women with Gestational Diabetes

What this Trial Is About

This trial evaluates the effects of fiber supplementation on medication needs and maternal and newborn health in women diagnosed with gestational diabetes managed by diet. Researchers aim to test whether adding fiber reduces the need for diabetes medication and improves pregnancy outcomes. The study is a randomized controlled trial ensuring unbiased comparison between groups. Participants are women with a single pregnancy diagnosed with diet-controlled gestational diabetes. They are randomly assigned to receive either psyllium fiber capsules providing 16 grams of soluble fiber daily throughout pregnancy or no fiber supplements. Randomization occurs at the gestational diabetes education class using computer-generated assignment in equal groups. During the study, women take fiber capsules twice daily if assigned to the intervention group. Researchers monitor the need for diabetes medication up to 7 months after randomization and assess many pregnancy and newborn health measures, including blood sugar control at delivery, complications like preeclampsia, delivery outcomes, and newborn infections. The total participation spans from enrollment until delivery and shortly after birth to track health outcomes for mother and baby.

Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes