Diabetes Type 1NCT04794283
Antenatal Hand Milking for Pregnant Women With Diabetes'
An observational study of Diabetes Type 1 and Diabetes Mellitus, Type 2, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 1, Diabetes Mellitus, Type 2, GDM
- What is being tested?
- Breast milk
- How many people
- 186 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2021to 1 Mar 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women with diabetes
Who may be able to join
- 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
Who cannot join
- women who don't have diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antenatal Hand Milking for Pregnant Women With Diabetes
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
Read the 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.
The woman's diabetes status will also be retrieved: what type of diabetes, duration of diabetes, blood sugar levels + Hba1c values and possibly treatment (insulin and/or metformin).
Delivery data such as: Labor onset ( spontaneous, induction, cesarean sectio). Progress and outcome (normal delivery, VE, sectio). Oxytocin stimulation. Pain relief.
Information about the newborn like: - Gestational age at birth. Gender, Height and weight. Apgar scores at 1', 5' and 10' min. - The child's blood sugar levels during the first 24 hours (at least three occasions). Number of occasions of hypoglycemia in the child in the first 24 hours (limit value <2.6 mmol/L).
- Bilirubin values and possible sun treatment of the child.
- Possible transfer of the child to the neonatal ward, and its cause,
- If the child has been fed with milk substitute and if so with what.
As the second part of the project, breast milk from 10 of the pregnant women with DM1, included in the prospective group, as well as 10 pregnant women who do not have diabetes will be asked for participation in that part of the study aimed to analyzing the content of colostrum.
The study participants will hand-milk at least 10ml of colostrum at pregnancy weeks 36, 37, 38, 39, 40, 41, 42 and freeze it and she will take all the milk in a freezer-clad cooler when she goes into childbirth. At postpartum days 1, 2, 3, 4 and 5, breast milk will also be collected. After that, the raw milk contains are analyzed on:
- Fats
- Proteins
- Calories
- Carbohydrates
- Total Solids Any differences between the two groups will be presented in logistical regressions.
- Conditions
- Diabetes Type 1, Diabetes Mellitus, Type 2, GDM
- Being tested
- Breast milk
- Keywords
- Diabetes type1, Diabetes type2, GDM
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast milkOther
Also called Milksubstitute
Milk substitute given during the first 24h
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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),
Measured: day 0
Secondary outcomes (1)
Hyperbilirubinemia during the first week of life will be meassured
High Bilirubin values within the first week of life
Measured: First week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Wiberg-Itzel, Karolinska Institutet
- Investigators
- Eva Wiberg-Itzel, Profeesor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794283
- Sponsor's protocol ID
- 2020-06042
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39889557
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Hand Milking for Pregnant Women With Diabetes
- ClinicalTrials.gov ID
- NCT04794283
- Acronym / sponsor ID
- 2020-06042
- Conditions
- Diabetes Type 1, Diabetes Mellitus, Type 2, GDM
- Keywords
- Diabetes type1, Diabetes type2, GDM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The woman's diabetes status will also be retrieved: what type of diabetes, duration of diabetes, blood sugar levels + Hba1c values and possibly treatment (insulin and/or metformin).
Delivery data such as: Labor onset ( spontaneous, induction, cesarean sectio). Progress and outcome (normal delivery, VE, sectio). Oxytocin stimulation. Pain relief.
Information about the newborn like: - Gestational age at birth. Gender, Height and weight. Apgar scores at 1', 5' and 10' min. - The child's blood sugar levels during the first 24 hours (at least three occasions). Number of occasions of hypoglycemia in the child in the first 24 hours (limit value <2.6 mmol/L).
- Bilirubin values and possible sun treatment of the child.
- Possible transfer of the child to the neonatal ward, and its cause,
- If the child has been fed with milk substitute and if so with what.
As the second part of the project, breast milk from 10 of the pregnant women with DM1, included in the prospective group, as well as 10 pregnant women who do not have diabetes will be asked for participation in that part of the study aimed to analyzing the content of colostrum.
The study participants will hand-milk at least 10ml of colostrum at pregnancy weeks 36, 37, 38, 39, 40, 41, 42 and freeze it and she will take all the milk in a freezer-clad cooler when she goes into childbirth. At postpartum days 1, 2, 3, 4 and 5, breast milk will also be collected. After that, the raw milk contains are analyzed on:
- Fats
- Proteins
- Calories
- Carbohydrates
- Total Solids Any differences between the two groups will be presented in logistical regressions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand milking with Diabetes | – | Other: Breast milk93 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with diabetes
Key inclusion criteria (5 listed)
- Pregnant women with DM1, DM2 and medically treated GDM
- Be patients in specialist maternity care at the hospital
- Plan to hand milk during pregnancy
- Start at 36w of gestation
Key exclusion criteria (1 listed)
- women who don't have diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast milkAlso: MilksubstituteMilk substitute given during the first 24h | Other | Hand milking with Diabetes |
Primary outcome
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),
1 secondary outcome
Hyperbilirubinemia during the first week of life will be meassured
Time frame: First week of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 39889557Monemi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Wiberg-Itzel, Profeesor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Type 1 and Diabetes Mellitus, Type 2, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal hypoglycemia on day 0 of life will be meassured (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04794283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.