- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04523454
Contraception and Pregnancy in Diabetes Mellitus (CAPRE-DM)
Study Overview
Status
Conditions
Detailed Description
Worldwide, 44% of pregnancies are unplanned; in the UK 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.
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, W2 1NY
- Imperial College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women aged 18-50 years (reproductive age) who are not currently pregnant
- Previous diagnosis of Diabetes Mellitus
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire - Number of women planning a pregnancy within the next year
Time Frame: 1 hour
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Quantitative data - Number of women planning a pregnancy within the next year
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1 hour
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Questionnaire - Invitation to and attendance at pre-conception counselling
Time Frame: 1 hour
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Quantitative data - Invitation to and attendance at pre-conception counselling
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1 hour
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Questionnaire - Current contraceptive choices
Time Frame: 1 hour
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Quantitative data - Current contraceptive choices
|
1 hour
|
Questionnaire - Knowledge of effect of diabetes on fertility
Time Frame: 1 hour
|
Quantitative data - Knowledge of effect of diabetes on fertility
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1 hour
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Questionnaire - Number of women who have had the importance of a planned pregnancy explained to them
Time Frame: 1 hour
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Quantitative data - Number of women who have had the importance of a planned pregnancy explained to them
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1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rochan Agha-Jaffar, Imperial College Healthcare NHS Trust
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20SM5701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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