Trial Outcomes & Findings for Contraception and Pregnancy in Diabetes Mellitus (NCT NCT04523454)

NCT ID: NCT04523454

Last Updated: 2024-09-23

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 96 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2024-09-23

Participant Flow

Participant milestones

Measure	Participants All participants were women of reproductive age with known diabetes under the care of Imperial College National Health Service (NHS) Trust who agreed to participate in the study.
Overall Study STARTED	96
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contraception and Pregnancy in Diabetes Mellitus

Baseline characteristics by cohort

Measure	Participants n=96 Participants Of the 405 women who were approached to participate, 96 women completed the questionnaire.
Age, Continuous	33 years n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants
Region of Enrollment United Kingdom	96 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: all participants

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

Outcome measures

Measure	Participants 'Prepared for Pregnancy' n=96 Participants Participants on no teratogenic medicaions, HbA1C \<48mmol/l and on folic acid
Number of Women 'Prepared for Pregnancy\	3 participants

SECONDARY outcome

Timeframe: 1 hour

Population: All participants

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

Outcome measures

Measure	Participants 'Prepared for Pregnancy' n=96 Participants Participants on no teratogenic medicaions, HbA1C \<48mmol/l and on folic acid
Number of Women Aware of the Importance of Good Glycaemic Control Prior to Pregnancy	69 Participants

SECONDARY outcome

Timeframe: 1 hour

Population: All participants

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

Outcome measures

Measure	Participants 'Prepared for Pregnancy' n=96 Participants Participants on no teratogenic medicaions, HbA1C \<48mmol/l and on folic acid
Number of Women Who Had Attended Pre-conception Counselling	17 Participants

SECONDARY outcome

Timeframe: 1 hour

Population: All participants

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

Outcome measures

Measure	Participants 'Prepared for Pregnancy' n=96 Participants Participants on no teratogenic medicaions, HbA1C \<48mmol/l and on folic acid
Number of Women Aware of Risks to the Foetus in Pregnancy in Women With Diabetes	89 participants

SECONDARY outcome

Timeframe: 1 hour

Population: All participants

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

Outcome measures

Measure	Participants 'Prepared for Pregnancy' n=96 Participants Participants on no teratogenic medicaions, HbA1C \<48mmol/l and on folic acid
Number of Women Aware of Any Risks to the Mother in Pregnancy With Pre-gestational Diabetes	80 Participants

Adverse Events

Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Rochan Agha-Jaffar

Imperial College London

Phone: 0203 311 3000

Email: Rochan.Agha-Jaffar@nhs.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place