Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04523454 |
| Other study ID # |
20SM5701 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2, 2020 |
| Est. completion date |
August 1, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
