Gestational diabetes in pregnancy Pregnancy and Childbirth
Conditions
Interventions
ARM 1 (Non-randomised):
Population: 20 pregnant women diagnosed with gestational diabetes with singleton pregnancies and a clinically documented plan to have birth by elective Caesarean section =37 w
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women who are pregnant with singleton pregnancy 2. Women with a documented diagnosis of gestational diabetes in their current pregnancy EITHER/OR Women who are documented to be currently treated for gestational diabetes due to a documented history of gestational diabetes in a previous pregnancy 3. Women who are able to give written informed consent to participate In addition: Arm 1: 1. Planned for elective Caesarean section at =37 weeks gestation 2. Women with gestational diabetes documented to be treated with diet alone Arm 2: 1. Women who are in the third trimester of pregnancy (=28+0 weeks and =36+0 weeks gestation at consent) 2. Women with gestational diabetes documented to be treated with diet alone Arm 3: 1. Women =36+0 weeks pregnant at randomisation 2. Women with gestational diabetes documented to be treated with diet and standard metformin IR (standard dose 1000 mg once daily or 500 mg twice daily) Please note: We use the term 'women' on this site and in the study protocol to refer to those who are pregnant, and give birth. We acknowledge that not all people who are pregnant and give birth identify as women, and it is important that evidence-based care for maternity, perinatal and postnatal health is inclusive. Our participant-facing study documents utilise appropriate gender-inclusive language.
Exclusion criteria
Exclusion criteria: 1. Pre-existing diabetes mellitus 2. Taking glucose-lowering agents other than metformin (insulin, glibenclamide) 3. Previous delivery of a baby 1 litre at Caesarean section, e.g. placenta praevia, >2 previous Caesarean sections 8. Currently lactating 9. Known fetal anomaly 10. Multiple pregnancy 11. History of, or currently clinically suspected, liver failure or dysfunction at the time of trial entry 12. History of, or currently clinically suspected, severe renal failure or dysfunction at the time of trial entry** 13. History of, or currently clinically suspected, (any type of) acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) 14. Previous known severe renal failure (GFR < 45 mL/min)** 15. Already enrolled in another randomised clinical trial involving IMP. 16. Taking prescribed drug known to affect renal function or result in haemodynamic change 17. Receiving investigation using iodinated contrast agent In addition: Arm 3: 18. Women who have two or more routine blood glucose values out of range at the same time point on consecutive days, within the 14 days prior to consent, without a valid reason in the opinion of the PI. 19. Women who regularly fail to check glucose by finger prick on 2 or more times per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fetal metformin exposure measured by the maternal: fetal serum metformin ratio using paired maternal and umbilical cord blood samples at delivery by elective Caesarean section in Arm 1 up to 3 months following delivery, data extracted from record of mother and baby. | — |
Secondary
| Measure | Time frame |
|---|---|
| Up to 3 months following delivery, data extracted from record of mother and baby: Arm 1: 1.1. Placental metformin level at delivery 1.2. Placental metformin transporter levels at delivery 1.3. Maternal plasma metformin level at delivery 1.4. Fetal serum metformin level at delivery 1.5. Fetal arterial:venous metformin ratio at delivery 1.6. Detection of metformin in maternal serum 24 hrs post-delivery Arm 2: 2.1. AUC of maternal serum metformin levels in the third trimester. 2.2. Pharmacokinetic parameters of metformin in maternal blood, including peak serum concentration, half-life, bioavailability, renal clearance 2.3. Metformin concentrations in maternal urine Arm 3: 3.1. Percentage of eligible participants recruited i.e. number who agree to take part out of all eligible participants who are approached. 3.2. Side-effects of treatment by questionnaire 3.3. Acceptability of treatment by questionnaire 3.4. Concordance with treatment by questionnaire 3.5. Percentage maternal blood glucose readings within local clinical target range 3.6. Need for additional gestational diabetes therapy at the end of 1 week of metformin DR/IR 3.7. Average plasma glucose concentration | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed