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NCT Number: NCT06867861

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Macon & Joan Brock Virginia Health Sciences at ODU

Norfolk, Virginia, 23507, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fiber

Dietary Supplement

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.

Primary outcomes

  1. Number of Participants with Need for GDM Medication

    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.

Secondary outcomes

  1. Hgb A1c at delivery

    Time frame: At delivery

    Measurement of Hgb A1c

  2. Rate of Fetal Demise

    Time frame: From date of randomization until the date of documented occurrence (assessed up to 7 months)

    Rate of fetal demise

  3. 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 fetal growth restriction

  4. 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 diagnosed with preeclampsia

  5. Number of Participants with Placental Abruption

    Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)

    Number of participants with placental abruption

  6. Mode of Delivery

    Time frame: At delivery

    Rates of cesarean and vaginal deliveries

  7. Indication for Cesarean Delivery

    Time frame: At delivery

    Rates of each indication for cesarean delivery

  8. Rate of Shoulder Dystocia

    Time frame: At delivery

    Rate of shoulder dystocia

  9. Quantitative Blood Loss

    Time frame: At delivery

    Blood loss in mL

  10. Rate of Postpartum Hemorrhage

    Time frame: At delivery

    Rates of patients with quantitative blood loss > 1000mL

  11. Rates of Infection

    Time frame: Delivery until discharge (assessed up to 5 days)

    Rates of infection

  12. Birth Weight

    Time frame: At delivery

    Birth weight

  13. Apgar Score

    Time frame: At delivery

    Apgar scores at delivery on a scale of 0 to 10, with higher scores meaning a better outcome

  14. Rates of Neonatal Infections

    Time frame: Delivery until discharge (assessed up to 5 days)

    Rates of neonatal infections

  15. Rate of Respiratory Distress Syndrome

    Time frame: At delivery

    Rate of respiratory distress syndrome

  16. Rate of Necrotizing Enterocolitis

    Time frame: Delivery until discharge (assessed up to 5 days)

    Rate of necrotizing enterocolitis

  17. Rate of NICU Admission

    Time frame: Delivery until discharge (assessed up to 5 days)

    Rate of admission to NICU

  18. Days in NICU

    Time frame: Delivery until discharge of the neonate (assessed up to 180 days)

    Days spent in NICU

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Registry information

Official study title

Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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