Gestational Diabetes Mellitus (GDM)
Conditions
Keywords
Gestational Diabetes Mellitus, Fiber, GDM
Brief summary
The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. In this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.
Detailed description
The study team proposes a randomized controlled trial of women with singleton pregnancies who present with a new diagnosis of diet-controlled gestational diabetes (previously referred to as GDMA1). The participants will be randomized to the intervention group (fiber supplementation) or control group (no fiber supplementation) in 1:1 fashion. The participant will be randomized by a number-generating computer software after recruitment at the new gestational diabetes education class.
Interventions
DIETARY_SUPPLEMENTFiber
Psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.
Sponsors
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Singleton gestation * Known or new diagnosis of gestational diabetes without reason for medication * Age \>=18 to \<=50
Exclusion criteria
* \- Non-English as primary language. * Known or suspected fetal anomaly or aneuploidy. * Known lower bowel disorder * Known phenylketonuria * Prisoners. * Management of diabetes outside of Eastern Virginia Medical School Maternal Fetal Medicine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Need for GDM Medication | From date of randomization until the date of first documented progression (assessed up to 7 months) | The primary outcome is the need for medication (either insulin or oral hypoglycemic agents) for management of gestational diabetes (progression from GDMA1 to GDMA2). We chose this primary outcome because the need for medication is associated with the need for significantly more antenatal interventions due to increased adverse pregnancy outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Fetal Demise | From date of randomization until the date of documented occurrence (assessed up to 7 months) | Rate of fetal demise |
| Number of Participants Diagnosed with Fetal Growth Restriction | From date of randomization until the date of first documented progression (assessed up to 7 months) | Number of participants diagnosed with fetal growth restriction |
| Number of Participants Diagnosed with Preeclampsia | From date of randomization until the date of first documented progression (assessed up to 7 months) | Number of participants diagnosed with preeclampsia |
| Number of Participants with Placental Abruption | From date of randomization until the date of first documented progression (assessed up to 7 months) | Number of participants with placental abruption |
| Mode of Delivery | At delivery | Rates of cesarean and vaginal deliveries |
| Indication for Cesarean Delivery | At delivery | Rates of each indication for cesarean delivery |
| Rate of Shoulder Dystocia | At delivery | Rate of shoulder dystocia |
| Quantitative Blood Loss | At delivery | Blood loss in mL |
| Hgb A1c at delivery | At delivery | Measurement of Hgb A1c |
| Rates of Infection | Delivery until discharge (assessed up to 5 days) | Rates of infection |
| Birth Weight | At delivery | Birth weight |
| Apgar Score | At delivery | Apgar scores at delivery on a scale of 0 to 10, with higher scores meaning a better outcome |
| Rates of Neonatal Infections | Delivery until discharge (assessed up to 5 days) | Rates of neonatal infections |
| Rate of Respiratory Distress Syndrome | At delivery | Rate of respiratory distress syndrome |
| Rate of Necrotizing Enterocolitis | Delivery until discharge (assessed up to 5 days) | Rate of necrotizing enterocolitis |
| Rate of NICU Admission | Delivery until discharge (assessed up to 5 days) | Rate of admission to NICU |
| Days in NICU | Delivery until discharge of the neonate (assessed up to 180 days) | Days spent in NICU |
| Rate of Postpartum Hemorrhage | At delivery | Rates of patients with quantitative blood loss \> 1000mL |
Countries
United States
Outcome results
None listed