Pregnancy in DiabeticsNCT02890836
Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes
An observational study of Pregnancy in Diabetics, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes. Second, to explore the prevalence of preeclampsia and preterm delivery in women with pre-existing diabetes with a) confirmed hypertension, b)… 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
- Pregnancy in Diabetics
- What is being tested?
- Antihypertensiva, mainly Metyldopa
- How many people
- 513 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2016to Feb 2021
- 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: A cohorte of unselected consecutive pregnant women with pre-existing type 1 and type 2 diabetes will be included.
Who may be able to join
- Women with pre-existing diabetes, older than 18 years and referred to The Center for Pregnant Women with Diabetes, Rigshospitalet, or the Centre for Diabetes and Pregnancy, Odense University Hospital, with a live singleton or twin pregnancy before 20 weeks during the inclusion period.
- Women with diabetes diagnosed in pregnancy before 20 weeks (HbA1c ≥48 mmol/mol) may also be included as having type 2 diabetes.
- Sufficient Danish language skills to read and understand the patient information sheet and to converse.
- Inclusion criteria for pregnant healthy women without diabetes:
- Women above 18 years of age, with a live singleton pregnancy, referred to a nuchal translucency scan at 11-14 weeks at The Department of Obstetrics, Rigshospitalet.
- Sufficient Danish language skills to read and understand the patient information sheet and to converse.
Who cannot join
- Women diagnosed with severe diseases that could possibly bias BP measurements or pregnancy outcome. This is judged by the principal investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes. Second, to explore the prevalence of preeclampsia and preterm delivery in women with pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure before entering the third trimester of pregnancy. Third, to explore the influence of lifestyle, gestational weight gain and mental well-being on confirmed hypertension and preeclampsia in pregnant women with diabetes.The recruitment period was in 2018 extended to 2020 to perform the following studies: First whether home BP in early pregnancy is superior to office BP to predict preeclampsia. Second to evaluate the prevalence of preeclampsia after initiation of a new treatment strategy including prophylactic aspirin and, in case of insufficiency, vitamin D supplementation.
Design: A prospective multicentre observational study where approximately 400 pregnant women with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP for three days three times during pregnancy as well as when the routinely measured office BP exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP >135/85 mmHg and home BP >130/80 mmHg) and white coat hypertension (office BP >135/85 mmHg but home BP ≤130/80 mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of antihypertensive treatment including impaired fetal haemodynamics and lower infant birth weight will be recorded. The women will complete food diaries and questionnaires on lifestyle and mental health three times in pregnancy in order to evaluate the influence of these parameters on hypertension and preeclampsia.
Read the detailed description
Design: Home blood pressure and office blood pressure as predictors of preeclampsia will be evaluated in the total cohort. From February 2018, the routine care includes treatment with prophylactic aspirin in all women with pre-existing diabetes and screening for vitamin D insufficiency, treated with vitamin D depending on the severity of the insufficiency. The prevalence of preeclampsia after initiation of the new treatment strategy will be evaluated. The women included from 2016-2018, where aspirin was only initiated if other risk factors to preeclampsia apart from diabetes were present, will be used for comparison.
- Conditions
- Pregnancy in Diabetics
- Being tested
- Antihypertensiva, mainly Metyldopa
- Keywords
- Blood pressure, Hypertension, White coat hypertension, Preeclampsia, Anti-hypertensiva
- Medical subject headings
- Pregnancy in Diabetics, Hypertension, White Coat Hypertension, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensiva, mainly MetyldopaDrug
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with pre-existing diabetes | Inclusion of 400 women is anticipated. Receives: Drug: Antihypertensiva, mainly Metyldopa | |
| Healthy pregnant women | Inclusion of 100 women is anticipated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed hypertension
Office blood pressure >135/85 mmHg measured twice at least 4 hours apart and home blood pressure >130/80 mmHg in pregnancy, or diagnosed hypertension with antihypertensive treatment from before pregnancy
Measured: 2 years
White coat hypertension
Office blood pressure >135/85 mmHg measured twice at least 4 hours apart, but home blood pressure ≤130/80 mmHg
Measured: 2 years
Preeclampsia
Measured: 4 years
Early preeclampsia
Preeclampsia occurring before 34 weeks
Measured: 4 years
Preterm birth
Birth before 37 completed weeks
Measured: 4 years
Early preterm delivery (international)
Birth before 32 completed weeks
Measured: 4 years
Early preterm delivery (Danish)
Birth before 34 completed weeks
Measured: 4 years
Secondary outcomes (2)
Gestational hypertension
De novo hypertension appearing after 20 weeks
Measured: 4 years
Chronic hypertension
Hypertension diagnosed prior to pregnancy, or during pregnancy before 20 weeks
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2020
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnancy in DiabeticsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Marianne Vestgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890836
- Sponsor's protocol ID
- H-15019186
- Status last verified
- May 2021
- First submitted
- 31 Aug 2016
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Do NC, Vestgaard M, Asbjornsdottir B, Andersen LLT, Jensen DM, Ringholm L, Damm P, Mathiesen ER. Home Blood Pressure for the Prediction of Preeclampsia in Women With Preexisting Diabetes. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3670-e3678. doi: 10.1210/clinem/dgac392.
PubMed 35766641Asbjornsdottir B, Vestgaard M, Do NC, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. Prevalence of anxiety and depression symptoms in pregnant women with type 2 diabetes and the impact on glycaemic control. Diabet Med. 2021 Mar;38(3):e14506. doi: 10.1111/dme.14506. Epub 2021 Jan 8.
PubMed 33368557Do NC, Vestgaard M, Asbjornsdottir B, Nichum VL, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. Physical activity, sedentary behavior and development of preeclampsia in women with preexisting diabetes. Acta Diabetol. 2020 May;57(5):559-567. doi: 10.1007/s00592-019-01459-7. Epub 2019 Nov 28.
PubMed 31781957Vestgaard M, Asbjornsdottir B, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. White coat hypertension in early pregnancy in women with pre-existing diabetes: prevalence and pregnancy outcomes. Diabetologia. 2019 Dec;62(12):2188-2199. doi: 10.1007/s00125-019-05002-9. Epub 2019 Oct 18.
PubMed 31628489
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes
- ClinicalTrials.gov ID
- NCT02890836
- Acronym / sponsor ID
- H-15019186
- Conditions
- Pregnancy in Diabetics
- Keywords
- Blood pressure, Hypertension, White coat hypertension, Preeclampsia, Anti-hypertensiva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes. Second, to explore the prevalence of preeclampsia and preterm delivery in women with pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure before entering the third trimester of pregnancy. Third, to explore the influence of lifestyle, gestational weight gain and mental well-being on confirmed hypertension and preeclampsia in pregnant women with diabetes.The recruitment period was in 2018 extended to 2020 to perform the following studies: First whether home BP in early pregnancy is superior to office BP to predict preeclampsia. Second to evaluate the prevalence of preeclampsia after initiation of a new treatment strategy including prophylactic aspirin and, in case of insufficiency, vitamin D supplementation.
Design: A prospective multicentre observational study where approximately 400 pregnant women with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP for three days three times during pregnancy as well as when the routinely measured office BP exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP >135/85 mmHg and home BP >130/80 mmHg) and white coat hypertension (office BP >135/85 mmHg but home BP ≤130/80 mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of antihypertensive treatment including impaired fetal haemodynamics and lower infant birth weight will be recorded. The women will complete food diaries and questionnaires on lifestyle and mental health three times in pregnancy in order to evaluate the influence of these parameters on hypertension and preeclampsia.
Detailed description
Design: Home blood pressure and office blood pressure as predictors of preeclampsia will be evaluated in the total cohort. From February 2018, the routine care includes treatment with prophylactic aspirin in all women with pre-existing diabetes and screening for vitamin D insufficiency, treated with vitamin D depending on the severity of the insufficiency. The prevalence of preeclampsia after initiation of the new treatment strategy will be evaluated. The women included from 2016-2018, where aspirin was only initiated if other risk factors to preeclampsia apart from diabetes were present, will be used for comparison.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with pre-existing diabetes | – | Drug: Antihypertensiva, mainly MetyldopaInclusion of 400 women is anticipated. |
| Healthy pregnant women | – | –Inclusion of 100 women is anticipated |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A cohorte of unselected consecutive pregnant women with pre-existing type 1 and type 2 diabetes will be included.
Key inclusion criteria (6 listed)
- Women with pre-existing diabetes, older than 18 years and referred to The Center for Pregnant Women with Diabetes, Rigshospitalet, or the Centre for Diabetes and Pregnancy, Odense University Hospital, with a live singleton or twin pregnancy before 20 weeks during the inclusion period.
- Women with diabetes diagnosed in pregnancy before 20 weeks (HbA1c ≥48 mmol/mol) may also be included as having type 2 diabetes.
- Sufficient Danish language skills to read and understand the patient information sheet and to converse.
- Women above 18 years of age, with a live singleton pregnancy, referred to a nuchal translucency scan at 11-14 weeks at The Department of Obstetrics, Rigshospitalet.
- Sufficient Danish language skills to read and understand the patient information sheet and to converse.
Key exclusion criteria (1 listed)
- Women diagnosed with severe diseases that could possibly bias BP measurements or pregnancy outcome. This is judged by the principal investigators.
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 |
|---|---|---|
| Antihypertensiva, mainly Metyldopa | Drug | Pregnant women with pre-existing diabetes |
Primary outcome
Confirmed hypertension
Time frame: 2 years
Office blood pressure >135/85 mmHg measured twice at least 4 hours apart and home blood pressure >130/80 mmHg in pregnancy, or diagnosed hypertension with antihypertensive treatment from before pregnancy
White coat hypertension
Time frame: 2 years
Office blood pressure >135/85 mmHg measured twice at least 4 hours apart, but home blood pressure ≤130/80 mmHg
Preeclampsia
Time frame: 4 years
Early preeclampsia
Time frame: 4 years
Preeclampsia occurring before 34 weeks
Preterm birth
Time frame: 4 years
Birth before 37 completed weeks
Early preterm delivery (international)
Time frame: 4 years
Birth before 32 completed weeks
Early preterm delivery (Danish)
Time frame: 4 years
Birth before 34 completed weeks
2 secondary outcomes
Gestational hypertension
Time frame: 4 years
Chronic hypertension
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Derived from this study: PubMed 35766641Do NC, Vestgaard M, Asbjornsdottir B, Andersen LLT, Jensen DM, Ringholm L, Damm P, Mathiesen ER. Home Blood Pressure for the Prediction of Preeclampsia in Women With Preexisting Diabetes. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3670-e3678. doi: 10.1210/clinem/dgac392.
- Derived from this study: PubMed 33368557Asbjornsdottir B, Vestgaard M, Do NC, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. Prevalence of anxiety and depression symptoms in pregnant women with type 2 diabetes and the impact on glycaemic control. Diabet Med. 2021 Mar;38(3):e14506. doi: 10.1111/dme.14506. Epub 2021 Jan 8.
- Derived from this study: PubMed 31781957Do NC, Vestgaard M, Asbjornsdottir B, Nichum VL, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. Physical activity, sedentary behavior and development of preeclampsia in women with preexisting diabetes. Acta Diabetol. 2020 May;57(5):559-567. doi: 10.1007/s00592-019-01459-7. Epub 2019 Nov 28.
- Derived from this study: PubMed 31628489Vestgaard M, Asbjornsdottir B, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. White coat hypertension in early pregnancy in women with pre-existing diabetes: prevalence and pregnancy outcomes. Diabetologia. 2019 Dec;62(12):2188-2199. doi: 10.1007/s00125-019-05002-9. Epub 2019 Oct 18.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pregnancy in Diabetics, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 26 May 2021. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Confirmed hypertension (time frame: 2 years). The study lists 7 primary outcomes in all. 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 NCT02890836, which also lists 4 linked publications.
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 26 May 2021.