Contraception and Pregnancy in Diabetes Mellitus (CAPRE-DM)

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1NY
    • Imperial College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women of reproductive age (18-50) with diabetes

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?

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	Quantitative data - Number of women planning a pregnancy within the next year	1 hour
Questionnaire - Invitation to and attendance at pre-conception counselling	Quantitative data - Invitation to and attendance at pre-conception counselling	1 hour
Questionnaire - Current contraceptive choices	Quantitative data - Current contraceptive choices	1 hour
Questionnaire - Knowledge of effect of diabetes on fertility	Quantitative data - Knowledge of effect of diabetes on fertility	1 hour
Questionnaire - Number of women who have had the importance of a planned pregnancy explained to them	Quantitative data - Number of women who have had the importance of a planned pregnancy explained to them	1 hour

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Rochan Agha-Jaffar, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2020
• Primary Completion (ACTUAL): August 1, 2021
• Study Completion (ACTUAL): August 1, 2021

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (ACTUAL): August 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes Mellitus, Type 1; Pregnancy in Diabetics
• Other Study ID Numbers: 20SM5701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No