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NCT04523454: CAPRE-DM

Contraception and Pregnancy in Diabetes Mellitus

Completed Results posted Last updated 23 September 2024
What this trial tests

trial in Diabetes Mellitus, Type 1 in 96 participants. Completed in 1 August 2021.

Timeline
2 October 2020
Primary endpoint
1 August 2021
1 August 2021

Quick facts

Lead sponsorImperial College London
StatusCompleted
Study typeOBSERVATIONAL
Enrollment96
Start date2 October 2020
Primary completion1 August 2021
Estimated completion1 August 2021
Sites1 location across United Kingdom

Conditions studied

Sponsor

Imperial College London

Who can join

Adults 18 to 50, female only, with Diabetes Mellitus, Type 1 or Contraception. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Women 'Prepared for Pregnancy\ Primary · 1 hour

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

GroupValue95% CI
Participants 'Prepared for Pregnancy'3
Number of Women Aware of the Importance of Good Glycaemic Control Prior to Pregnancy Secondary · 1 hour

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

GroupValue95% CI
Participants69
Number of Women Who Had Attended Pre-conception Counselling Secondary · 1 hour

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

GroupValue95% CI
Participants17
Number of Women Aware of Risks to the Foetus in Pregnancy in Women With Diabetes Secondary · 1 hour

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

GroupValue95% CI
Participants89
Number of Women Aware of Any Risks to the Mother in Pregnancy With Pre-gestational Diabetes Secondary · 1 hour

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

GroupValue95% CI
Participants80

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

Other Imperial College London trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04523454.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing