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Contraception and Pregnancy in Diabetes Mellitus

Contraception and Pregnancy in Diabetes Mellitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04523454
Acronym
CAPRE-DM
Enrollment
96
Registered
2020-08-21
Start date
2020-10-02
Completion date
2021-08-01
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Diabetes Mellitus, Type 1

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.

Interventions

None listed

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Women 'Prepared for Pregnancy\1 hourQuantitative data - Number of women 'prepared for pregnancy - HbA1C \<48mmol/mol, on folic acid, on no teratogenic medications

Secondary

MeasureTime frameDescription
Number of Women Aware of the Importance of Good Glycaemic Control Prior to Pregnancy1 hourQuantitative - Number of women aware of the importance of good glycaemic control prior to pregnancy
Number of Women Who Had Attended Pre-conception Counselling1 hourQuantitative - Number of women who had attended pre-conception counselling
Number of Women Aware of Risks to the Foetus in Pregnancy in Women With Diabetes1 hourQuantitative - 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 Diabetes1 hourQuantitative - number of women aware of any risks to the mother in pregnancy with pre-gestational diabetes

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Participants
Of the 405 women who were approached to participate, 96 women completed the questionnaire.
96
Total96

Baseline characteristics

CharacteristicParticipants
Age, Continuous33 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
57 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
39 Participants
Region of Enrollment
United Kingdom
96 participants
Sex: Female, Male
Female
96 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 96
other
Total, other adverse events
0 / 96
serious
Total, serious adverse events
0 / 96

Outcome results

Primary

Number of Women 'Prepared for Pregnancy\

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

Time frame: 1 hour

Population: all participants

ArmMeasureValue (NUMBER)
Participants 'Prepared for Pregnancy'Number of Women 'Prepared for Pregnancy\3 participants
Secondary

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

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

Time frame: 1 hour

Population: All participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants 'Prepared for Pregnancy'Number of Women Aware of Any Risks to the Mother in Pregnancy With Pre-gestational Diabetes80 Participants
Secondary

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

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

Time frame: 1 hour

Population: All participants

ArmMeasureValue (NUMBER)
Participants 'Prepared for Pregnancy'Number of Women Aware of Risks to the Foetus in Pregnancy in Women With Diabetes89 participants
Secondary

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

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

Time frame: 1 hour

Population: All participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants 'Prepared for Pregnancy'Number of Women Aware of the Importance of Good Glycaemic Control Prior to Pregnancy69 Participants
Secondary

Number of Women Who Had Attended Pre-conception Counselling

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

Time frame: 1 hour

Population: All participants

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Participants 'Prepared for Pregnancy'Number of Women Who Had Attended Pre-conception Counselling17 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026