NCT Number: NCT06867861
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Norfolk, Virginia, 23507, United States
Location status: Recruiting
Jerri Waller, MD
PRINCIPAL_INVESTIGATOR
Kristin Ayers, MPH
CONTACT
Morgan Scaglione, MD
CONTACT
Morgan Scaglione, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: At delivery
Measurement of Hgb A1c
Time frame: From date of randomization until the date of documented occurrence (assessed up to 7 months)
Rate of fetal demise
Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)
Number of participants diagnosed with fetal growth restriction
Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)
Number of participants diagnosed with preeclampsia
Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)
Number of participants with placental abruption
Time frame: At delivery
Rates of cesarean and vaginal deliveries
Time frame: At delivery
Rates of each indication for cesarean delivery
Time frame: At delivery
Rate of shoulder dystocia
Time frame: At delivery
Blood loss in mL
Time frame: At delivery
Rates of patients with quantitative blood loss > 1000mL
Time frame: Delivery until discharge (assessed up to 5 days)
Rates of infection
Time frame: At delivery
Birth weight
Time frame: At delivery
Apgar scores at delivery on a scale of 0 to 10, with higher scores meaning a better outcome
Time frame: Delivery until discharge (assessed up to 5 days)
Rates of neonatal infections
Time frame: At delivery
Rate of respiratory distress syndrome
Time frame: Delivery until discharge (assessed up to 5 days)
Rate of necrotizing enterocolitis
Time frame: Delivery until discharge (assessed up to 5 days)
Rate of admission to NICU
Time frame: Delivery until discharge of the neonate (assessed up to 180 days)
Days spent in NICU
Eastern Virginia Medical School
Other
Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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