Clinical trial NCT04523454: Contraception and Pregnancy in Diabetes Mellitus
Official title: Contraception and Pregnancy in Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Contraception
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of reproductive age (18-50) with diabetes

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 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.

Eligibility 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

Primary outcomes:
measure: Number of Women 'Prepared for Pregnancy\
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Women Aware of the Importance of Good Glycaemic Control Prior to Pregnancy
timeFrame: 1 hour
measure: Number of Women Who Had Attended Pre-conception Counselling
timeFrame: 1 hour
measure: Number of Women Aware of Risks to the Foetus in Pregnancy in Women With Diabetes
timeFrame: 1 hour
measure: Number of Women Aware of Any Risks to the Mother in Pregnancy With Pre-gestational Diabetes
timeFrame: 1 hour
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Rochan Agha-Jaffar
role: PRINCIPAL_INVESTIGATOR
References: