Contraception and Pregnancy in Diabetes Mellitus

Completed

• Conditions: Contraception; Diabetes Mellitus, Type 1

• Registration Number: NCT04523454
• Lead Sponsor: Imperial College London

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.

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 Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Study Start: 2020-10-02
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Women 'Prepared for Pregnancy\	1 hour	Quantitative data - Number of women 'prepared for pregnancy - HbA1C \<48mmol/mol, on folic acid, on no teratogenic medications

Secondary Outcome Measures

Name	Time	Method
Number of Women Aware of the Importance of Good Glycaemic Control Prior to Pregnancy	1 hour	Quantitative - Number of women aware of the importance of good glycaemic control prior to pregnancy
Number of Women Who Had Attended Pre-conception Counselling	1 hour	Quantitative - Number of women who had attended pre-conception counselling
Number of Women Aware of Risks to the Foetus in Pregnancy in Women With Diabetes	1 hour	Quantitative - Number of women aware of risks to the foetus in pregnancy in women with diabetes
Number of Women Aware of Any Risks to the Mother in Pregnancy With Pre-gestational Diabetes	1 hour	Quantitative - number of women aware of any risks to the mother in pregnancy with pre-gestational diabetes

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom