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NCT04794283
Antenatal Hand Milking for Pregnant Women With Diabetes'
trial testing Breast milk in Diabetes Type 1 in 186 participants. Status unknown.
1 March 2022
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 186 |
| Start date | 1 March 2021 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 March 2023 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Breast milk — full drug profile →
Conditions studied
- Diabetes Type 1 — all drugs for Diabetes Type 1 →
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- GDM — all drugs for GDM →
Sponsor
Karolinska Institutet
Who can join
18 and older, female only, with Diabetes Type 1 or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The impact of lowering the blood glucose cut-off values in gestational diabetes mellitus on maternal and perinatal outcomes.
Monemi E, Tingström J, Sterpu I, Wiberg-Itzel E. · · 2025 · PMID 39889557 · DOI 10.1016/j.ejogrb.2025.01.031
Verify or expand the search:
- PubMed search for NCT04794283
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04794283 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karolinska Institutet
- Last refreshed: 31 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04794283.
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