Pregnancy and Childbirth
Conditions
Interventions
Semaglutide
Sponsors
INFECTIOUS DISEASES INSTITUTE
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal authorized representative) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Diagnosed with GDM in the recent pregnancy according to Ugandan guidelines 4. Woman aged 18 years or older 5. Breastfeeding at enrolment or intending to breastfeed during study participation 6. Willing to use adequate contraception for the duration of the study and 8 weeks after semaglutide exposure. 7. No obstetric complication like antepartum hemorrhage, severe postpartum heamorrhage, eclampsia, PET with severe features
Exclusion criteria
Exclusion criteria: Need for insulin therapy ? Need for oral hypoglycaemic treatment ? Elevation in amylase or lipase beyond normal limits ? History of pancreatitis ? Liver function tests (AST) or creatinine more than twice the upper limit of normal ? Severe physical or mental health condition which would preclude participation ? Infant with prematurity (<36 weeks), low birth weight (<2.5 kg), or major congenital abnormality detected at birth ? Baseline Body Mass Index <20 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? Steady state concentrations of semaglutide in maternal plasma and breastmilk at pre-dose (0 h), and at 12 h, 24 h, 48 h, 72 h, 120 h, 144 h, and 168 h post-dose relative to the 9th subcutaneous dose, at 0.5mg or the 13th subcutaneous dose, at 1.0 mg ? Concentrations of semaglutide in infant plasma at pre-dose (0 h), and 24 h, 48 h, 72 h post maternal dose (sample to be obtained via heel prick, as in other MILK studies) ? Breastmilk to maternal plasma ratio of semaglutide | — |
Secondary
| Measure | Time frame |
|---|---|
| Breastmilk composition (fatty acids, proteins and lactose) and pH ? Breastmilk volume assessment ? Infant growth and development, using standard anthropometric indices – weight, length, head circumference) and simple developmental assessment tools ? Maternal perceptions (Treatment Satisfaction Questionnaire) ? Trend of maternal HbA1c ? Maternal body composition (BMI, lipid profile, hip/waist circ) | — |
Countries
Uganda
Contacts
Public ContactPaul Gonza
Infectious Diseases Institute
Outcome results
None listed