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Contraception and Pregnancy in Diabetes Mellitus (CAPRE-DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04523454
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief 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. 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.

Condition or disease
Diabetes Mellitus, Type 1 Contraception

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 Design
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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Contraception and Pregnancy in Diabetes Mellitus
Actual Study Start Date : October 2, 2020
Actual Primary Completion Date : August 1, 2021
Actual Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Questionnaire - Number of women planning a pregnancy within the next year [ Time Frame: 1 hour ]
    Quantitative data - Number of women planning a pregnancy within the next year

  2. Questionnaire - Invitation to and attendance at pre-conception counselling [ Time Frame: 1 hour ]
    Quantitative data - Invitation to and attendance at pre-conception counselling

  3. Questionnaire - Current contraceptive choices [ Time Frame: 1 hour ]
    Quantitative data - Current contraceptive choices

  4. Questionnaire - Knowledge of effect of diabetes on fertility [ Time Frame: 1 hour ]
    Quantitative data - Knowledge of effect of diabetes on fertility

  5. Questionnaire - Number of women who have had the importance of a planned pregnancy explained to them [ Time Frame: 1 hour ]
    Quantitative data - Number of women who have had the importance of a planned pregnancy explained to them


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women aged 18-50 years (reproductive age) who are not currently pregnant
Sampling Method:   Non-Probability Sample
Study Population
Women of reproductive age (18-50) with diabetes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523454


Locations
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United Kingdom
Imperial College London
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Rochan Agha-Jaffar Imperial College Healthcare NHS Trust
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04523454    
Other Study ID Numbers: 20SM5701
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy in Diabetics
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pregnancy Complications