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Completed

NCT Number: NCT04523454

Contraception and Pregnancy in Diabetes Mellitus

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Imperial College London

London, W2 1NY, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Women 'Prepared for Pregnancy\

    Time frame: 1 hour

    Quantitative data - Number of women 'prepared for pregnancy - HbA1C <48mmol/mol, on folic acid, on no teratogenic medications

Secondary outcomes

  1. Number of Women Aware of the Importance of Good Glycaemic Control Prior to Pregnancy

    Time frame: 1 hour

    Quantitative - Number of women aware of the importance of good glycaemic control prior to pregnancy

  2. Number of Women Who Had Attended Pre-conception Counselling

    Time frame: 1 hour

    Quantitative - Number of women who had attended pre-conception counselling

  3. Number of Women Aware of Risks to the Foetus in Pregnancy in Women With Diabetes

    Time frame: 1 hour

    Quantitative - Number of women aware of risks to the foetus in pregnancy in women with diabetes

  4. Number of Women Aware of Any Risks to the Mother in Pregnancy With Pre-gestational Diabetes

    Time frame: 1 hour

    Quantitative - number of women aware of any risks to the mother in pregnancy with pre-gestational diabetes

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: CAPRE-DM

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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