Antenatal Hand Milking for Pregnant Women With Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Karolinska Institutet
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- neonatal hypoglycemia on day 0 of life will be meassured
Study Overview
Brief Summary
The project is a descriptive cohort study with a retrospective and a prospective group where pregnancy and childbirth data will be studied. Mothers with DM1, DM2, GDM hand-milk 2 times/day from v.36+0, freeze the colostrum they receive and bring it to delivery ward. The colostrum will then be given instead of milk substitutes for their children postpartum.
The primary questions are whether there is any statistical difference between a group that provides only colostrum compared to an equal retrospective group, which has only been given milk substitutes, in the case of neonatal hypoglycemia in the first 24 hours postpartum.
Secondly: 10 healthy women and 10women with DM1 will provide analysis of colostrum at week 36 of pregnancy. The secondary question is if there is any differences in colostrum whether the mother is healthy or has DMtype1
Detailed Description
The project is a descriptive cohort study with a retrospective and a prospective group where pregnancy and childbirth data will be studied. 93 mothers with DM1, DM2, GDM will hand-milk 2 times/day from v.36+0, freeze the colostrum they receive and bring it to delivery ward. The colostrum will then be given instead of milk substitutes for their children postpartum.
Population: 93 women with DM1, DM2 and medically treated GDM who are patients in specialist maternity care at Soderhospital in Stockholm, and who plan to hand milk, are the prospective group. A retrospective group of 93 diabetic women is then selected from 1 April 2021 and back from the medical database used in the clinic and they represent the retrospective group where milk substitutes has been given.
The primary question of the study is whether there is any statistical difference between a group of diabetic newborn that provides only colostrum compared to an equal retrospective group, which has only given milk substitutes, in the case of neonatal hypoglycemia in the first 24 hours postpartum.
Second question in the study is to study the difference in developing sun-treatment-demanding icterus between the children who received colostrum or milk substitutes first 24h and possible transfer of them to neonatal care.
Maternal outcome and background data will be retrieved from the maternal medical files.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnant women with DM1, DM2 and medically treated GDM
- •Women must:
- •Be patients in specialist maternity care at the hospital
- •Plan to hand milk during pregnancy
- •Start at 36w of gestation
Exclusion Criteria
- •women who don't have diabetes
Outcomes
Primary Outcomes
neonatal hypoglycemia on day 0 of life will be meassured
Time Frame: day 0
The child's blood sugar levels in the first day of life (at least three occasions). - the number of occasions of hypoglycemia in the child in the first 24 hours (limit value \<2,6 mmol/L),
Secondary Outcomes
- Hyperbilirubinemia during the first week of life will be meassured(First week of life)
Investigators
Eva Wiberg-Itzel
Associate professor
Karolinska Institutet