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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Women 'Prepared for Pregnancy\ | Quantitative data - Number of women 'prepared for pregnancy - HbA1C <48mmol/mol, on folic acid, on no teratogenic medications | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 hour |
| Number of Women Who Had Attended Pre-conception Counselling |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 18-50 years (reproductive age) who are not currently pregnant
Women of reproductive age (18-50) with diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Rochan Agha-Jaffar | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | W2 1NY | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | All participants were women of reproductive age with known diabetes under the care of Imperial College National Health Service (NHS) Trust who agreed to participate in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
As per participant flow
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Of the 405 women who were approached to participate, 96 women completed the questionnaire. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Women 'Prepared for Pregnancy\ | Quantitative data - Number of women 'prepared for pregnancy - HbA1C <48mmol/mol, on folic acid, on no teratogenic medications | all participants | Posted | Number | participants | 1 hour |
|
|
10 months (i.e. through whole study period) - and reviewed every month
Definitions as per website clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | 96 women with pre-gestational diabetes who completed a questionnaire |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Rochan Agha-Jaffar | Imperial College London | 0203 311 3000 | 21253 | Rochan.Agha-Jaffar@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2020 | Sep 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Quantitative - Number of women who had attended pre-conception counselling |
| 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 | 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 | 1 hour |
| years |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 | All participants | Posted | Count of Participants | Participants | 1 hour |
|
|
|
| Secondary | Number of Women Who Had Attended Pre-conception Counselling | Quantitative - Number of women who had attended pre-conception counselling | All participants | Posted | Count of Participants | Participants | 1 hour |
|
|
|
| Secondary | 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 | All participants | Posted | Number | participants | 1 hour |
|
|
|
| Secondary | 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 | All participants | Posted | Count of Participants | Participants | 1 hour |
|
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |