Gestational Diabetes Mellitus
Conditions
Brief summary
Scientific background: Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Treatment of GDM is multidisciplinary and includes lifestyle changes and medications. However, the efficacy of these treatments is limited due to poor motivation, daily painful blood tests and multiple injections. Probiotic supplements were shown to modulate the gut microbiome by reducing the adverse metabolic effects associated with pathogenic microbial colonization. Promising effects on glycemic control and insulin resistance in non-pregnant diabetic patients were reported. However, the effect of probiotics on glycemic control in GDM has not been elucidated. Objectives: To examine the effect of a mixture of probiotic strains given daily on maternal glycemic parameters, and pregnancy outcomes among women with GDM. Working hypothesis: Oral administration of probiotics will be effective in glucose control of patients with GDM and their neonates without causing significant adverse effects. Type of research and methods of data collection: A prospective randomized, double blind, placebo controlled trial. Women newly diagnosed with GDM will be recruited and followed in the GDM clinic and Maternal-Fetal Medicine ward (including the research clinic) at Emek Medical Center. They will be divided into a research group, receiving the probiotic formula Femina II and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control will be evaluated by daily glucose charts. After 2 weeks of diet and probiotic/placebo treatment and thereafter, pharmacotherapy will be started in case of poor glycemic control according to the daily glucose charts. Blood tests for glycated molecules will be performed. Fetal well-being and growth will be assessed. The primary outcomes are: 1. The rate of women requiring medications for glycemic control 2. Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.
Interventions
DIETARY_SUPPLEMENTFemina II
2 capsules per day until delivery
OTHERPlacebo
2 capsules per day until delivery
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women who were diagnosed with GDM from 13 to 32.6 gestational weeks * 18 years old and older * Singleton pregnancy
Exclusion criteria
* Women with pre-gestational diabetes mellitus * GDM diagnosed ≥ 33 gestational weeks * Women using prophylactic antimicrobial treatment * Immunocompromised women * Multiple pregnancy * Women taking oral probiotic products who refuse to stop the consumption (food-containing probiotics is not considered an exclusion criterion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of women who will require pharmacotherapy for glycemic control. | During the length of pregnancy (up to 9 months) |
| Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products. | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mean daily pre-prandial glucose values | During the length of pregnancy (up to 9 months) |
| Mean daily post-prandial glucose values | During the length of pregnancy (up to 9 months) |
| Level of glycated molecules | During the length of pregnancy (up to 9 months) |
| The rate of women with mean pre-prandial values ≥ 95 mg/dl, mean post-prandial values ≥ 130 mg/dl, and mean daily glucose > 100 mg/dl | During the length of pregnancy (up to 9 months) |
| The rate of cesarean deliveries | At delivery |
| The rate of labor inductions | At delivery |
| The rate of birth weight≥4000 gr | At delivery |
| The rate of birth weight> 90th percentile | At delivery |
| The rate of admission to the neonatal intensive care unit | Within a week from delivery |
| Apgar score at 1 and 5 minutes from birth | Within 1-5 minutes after delivery |
| The rate of women with controlled diabetes | During the length of pregnancy (up to 9 months) |
| The rate of neonatal hyperbilirubinemia | Within a week from delivery |
| The rate of neonatal polycythemia | Within a week from delivery |
| The rate of neonatal hypocalcemia | Within a week from delivery |
| The rate of neonatal hypomagnesemia | Within a week from delivery |
| Cord blood pH levels | At delivery |
| The rate of neonatal malformations and developmental disorders | 1-2 days after delivery |
| birth weight | At delivery |
| Head circumference | 1-2 days after delivery |
| Maternal adverse effects | During the length of pregnancy (up to 9 months) |
| Duration of time until pharmacotherapy for glycemic control is indicated | During the length of pregnancy (up to 9 months) |
| The rate of neonatal hypoglycemia | Within 1-2 days after delivery |
| Mean daily glucose charts | During the length of pregnancy (up to 9 months) |
Countries
Israel
Outcome results
None listed