Antenatal Hand Milking for Pregnant Women With Diabetes'

NCT04794283 | Unknown

• 1 other identifier: 2020-06042
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Type 1; Diabetes Mellitus, Type 2; GDM

Keywords

Diabetes type1; Diabetes type2; GDM

Outcome Measures

Primary Outcomes (1)

• neonatal hypoglycemia on day 0 of life will be meassured

  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),

  day 0

Secondary Outcomes (1)

• Hyperbilirubinemia during the first week of life will be meassured

  First week of life

Study Arms (2)

Hand milking with Diabetes

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 part of this group.

Other: Breast milk

Not hand milking with diabetes

A group of 93 women are then selected from 1 April 2021and back in the same number as the group1 (n=93) this group only gave milk substitute the first 24h.

Interventions

Breast milk OTHER

Milk substitute given during the first 24h

Also known as: Milksubstitute

Hand milking with Diabetes

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women with diabetes

You may qualify if:

• 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

You may not qualify if:

• women who don't have diabetes

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

Location

Related Publications (1)

• Monemi E, Tingstrom J, Sterpu I, Wiberg-Itzel E. The impact of lowering the blood glucose cut-off values in gestational diabetes mellitus on maternal and perinatal outcomes. Eur J Obstet Gynecol Reprod Biol. 2025 Apr;307:43-48. doi: 10.1016/j.ejogrb.2025.01.031. Epub 2025 Jan 22.

  PMID: 39889557 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Eva Wiberg-Itzel, Profeesor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 12, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)