Diabetes Mellitus, Type 1CAPRE-DMNCT04523454
Contraception and Pregnancy in Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 1 and Contraception, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study seeks to expand upon and update this body of work. It will explore the knowledge and understanding women with diabetes have around pregnancy and conception, as well as establish how well prepared these women are for a pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Diabetes Mellitus, Type 1, Contraception
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2020to 1 Aug 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- Women only
- Adult
Study population: Women of reproductive age (18-50) with diabetes
Who may be able to join
- Women aged 18-50 years (reproductive age) who are not currently pregnant
- Previous diagnosis of Diabetes Mellitus
Who cannot join
- Inability to understand and write in the English language
- Unable to participate due to other factors, as assessed by the Chief Investigators
- A history of gestational diabetes but not diabetes mellitus.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to expand upon and update this body of work. It will explore the knowledge and understanding women with diabetes have around pregnancy and conception, as well as establish how well prepared these women are for a pregnancy. Using this data, we will develop better services to inform women with diabetes about the contraception and pregnancy, as well inform the development of pre-conception counselling services for women with diabetes. If successful, we would anticipate seeing an improvement in performance in future National Diabetes in Pregnancy audits.
Read the detailed description
Worldwide, 44% of pregnancies are unplanned; in the United Kingdom 45% of pregnancies and one third of births are unplanned. If a woman wants 2 children, she will spend, on average, 5 years trying to conceive or being pregnant, and 30 years trying to prevent pregnancy.
Women with diabetes are known to have 'high-risk' pregnancies. Complications for the mother include worsening diabetic control, particularly with increased hypoglycaemia in the 1st trimester; deterioration in retinopathy and nephropathy; pre-eclampsia; birth trauma due to fetal macrosomia. For the fetus, there are increased risks of congenital abnormalities; macrosomia with resultant birth trauma including shoulder dystocia; intrauterine growth restriction; miscarriage; still birth; neonatal unit admission and neonatal death.
The National Institute of Clinical and Health Excellence (NICE) guidance (NG3) contains a number of recommendations to prepare women with diabetes for a healthy pregnancy, and recommendations to avoid a pregnancy in poorly controlled diabetes; it also has recommendations about contraception. However, the National Diabetes in Pregnancy Audit 2019 shows that seven out of eight women are not adequately prepared pre-pregnancy, and there are still increased numbers of neonatal deaths, stillbirths, congenital anomalies, large and small for gestational age babies and neonatal unit admissions, compared to pregnancies in women without diabetes.
The cause for these poor outcomes, despite the NICE guidance, needs to be understood to enable pregnancy outcomes to improve. One likely factor is poor patient knowledge about the complications associated with pregnancy. One study, undertaken in 2009, showed that only 35% of women with diabetes of reproductive age recalled having any discussion about pregnancy, and only 25% were aware of any of the risks associated with pregnancy. Another study in women with diabetes seen in an antenatal clinic showed that even if a woman was aware of the risks associated with diabetes in pregnancy, she often did not attend for pre-conception counselling and preparation. The reasons for this were multifactorial, including falling pregnant faster than expected, and pervious poor interactions with healthcare professionals.
- Conditions
- Diabetes Mellitus, Type 1, Contraception
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Women 'Prepared for Pregnancy\
Quantitative data - Number of women 'prepared for pregnancy - HbA1C <48mmol/mol, on folic acid, on no teratogenic medications
Measured: 1 hour
Secondary outcomes (4)
Number of Women Aware of the Importance of Good Glycaemic Control Prior to Pregnancy
Quantitative - Number of women aware of the importance of good glycaemic control prior to pregnancy
Measured: 1 hour
Number of Women Who Had Attended Pre-conception Counselling
Quantitative - Number of women who had attended pre-conception counselling
Measured: 1 hour
Number of Women Aware of Risks to the Foetus in Pregnancy in Women With Diabetes
Quantitative - Number of women aware of risks to the foetus in pregnancy in women with diabetes
Measured: 1 hour
Number of Women Aware of Any Risks to the Mother in Pregnancy With Pre-gestational Diabetes
Quantitative - number of women aware of any risks to the mother in pregnancy with pre-gestational diabetes
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start2 Oct 2020
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rochan Agha-Jaffar, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523454
- Sponsor's protocol ID
- 20SM5701
- Acronym
- CAPRE-DM
- Status last verified
- May 2024
- First submitted
- 19 Aug 2020
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraception and Pregnancy in Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04523454
- Acronym / sponsor ID
- CAPRE-DM / 20SM5701
- Conditions
- Diabetes Mellitus, Type 1, Contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to expand upon and update this body of work. It will explore the knowledge and understanding women with diabetes have around pregnancy and conception, as well as establish how well prepared these women are for a pregnancy. Using this data, we will develop better services to inform women with diabetes about the contraception and pregnancy, as well inform the development of pre-conception counselling services for women with diabetes. If successful, we would anticipate seeing an improvement in performance in future National Diabetes in Pregnancy audits.
Detailed description
Worldwide, 44% of pregnancies are unplanned; in the United Kingdom 45% of pregnancies and one third of births are unplanned. If a woman wants 2 children, she will spend, on average, 5 years trying to conceive or being pregnant, and 30 years trying to prevent pregnancy.
Women with diabetes are known to have 'high-risk' pregnancies. Complications for the mother include worsening diabetic control, particularly with increased hypoglycaemia in the 1st trimester; deterioration in retinopathy and nephropathy; pre-eclampsia; birth trauma due to fetal macrosomia. For the fetus, there are increased risks of congenital abnormalities; macrosomia with resultant birth trauma including shoulder dystocia; intrauterine growth restriction; miscarriage; still birth; neonatal unit admission and neonatal death.
The National Institute of Clinical and Health Excellence (NICE) guidance (NG3) contains a number of recommendations to prepare women with diabetes for a healthy pregnancy, and recommendations to avoid a pregnancy in poorly controlled diabetes; it also has recommendations about contraception. However, the National Diabetes in Pregnancy Audit 2019 shows that seven out of eight women are not adequately prepared pre-pregnancy, and there are still increased numbers of neonatal deaths, stillbirths, congenital anomalies, large and small for gestational age babies and neonatal unit admissions, compared to pregnancies in women without diabetes.
The cause for these poor outcomes, despite the NICE guidance, needs to be understood to enable pregnancy outcomes to improve. One likely factor is poor patient knowledge about the complications associated with pregnancy. One study, undertaken in 2009, showed that only 35% of women with diabetes of reproductive age recalled having any discussion about pregnancy, and only 25% were aware of any of the risks associated with pregnancy. Another study in women with diabetes seen in an antenatal clinic showed that even if a woman was aware of the risks associated with diabetes in pregnancy, she often did not attend for pre-conception counselling and preparation. The reasons for this were multifactorial, including falling pregnant faster than expected, and pervious poor interactions with healthcare professionals.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women of reproductive age (18-50) with diabetes
Key inclusion criteria (2 listed)
- Women aged 18-50 years (reproductive age) who are not currently pregnant
- Previous diagnosis of Diabetes Mellitus
Key exclusion criteria (4 listed)
- Inability to understand and write in the English language
- Unable to participate due to other factors, as assessed by the Chief Investigators
- A history of gestational diabetes but not diabetes mellitus.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Women 'Prepared for Pregnancy\
Time frame: 1 hour
Quantitative data - Number of women 'prepared for pregnancy - HbA1C <48mmol/mol, on folic acid, on no teratogenic medications
4 secondary outcomes
Number of Women Aware of the Importance of Good Glycaemic Control Prior to Pregnancy
Time frame: 1 hour
Number of Women Who Had Attended Pre-conception Counselling
Time frame: 1 hour
Number of Women Aware of Risks to the Foetus in Pregnancy in Women With Diabetes
Time frame: 1 hour
Number of Women Aware of Any Risks to the Mother in Pregnancy With Pre-gestational Diabetes
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Rochan Agha-Jaffar principal investigator
Imperial College Healthcare NHS Trust
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 Mellitus, Type 1 and Contraception, run by Imperial College London at 1 site in United Kingdom.
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 2 inclusion and 4 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 23 Sep 2024. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Women 'Prepared for Pregnancy\ (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.