Pre-pregnancy care for women with type 2 diabetes

Not Applicable

Conditions: Pre-pregnancy care for women living with type 2 diabetes
Nutritional, Metabolic, Endocrine
Type 2 diabetes mellitus

Registration Number: ISRCTN47576591

Lead Sponsor: King's College London

Brief Summary: 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35418031/ protocol (added 18/01/2023)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: Female

Target Recruitment: 750

Inclusion Criteria

1. Women living with Type 2 diabetes aged 18-45 years attending one of the participating GP practices
2. GP practice participation is limited to those in Lambeth and Southwark with more than 25 women meeting the eligibility criteria registered to the practice.

Exclusion Criteria

1. Women who do not have Type 2 diabetes or are not attending one of the participating GP practices
2. GP practice participation in Lambeth and Southwark with less than 25 women meeting the eligibility criteria registered to the practice

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extracted in anonymised format from a template embedded into the electronic records within each of the participating GP practices at baseline and quarterly during the observation period at study months 10, 14, 18 and 22:<br>1. HbA1c testing and results (number of patients =48 mmol/mol [6.5%])<br>2. Number of patients commencing on folic acid 5 mg<br>3. Number of patients ceasing potentially teratogenic therapies

Secondary Outcome Measures

Name	Time	Method
Extracted in anonymised format from a template embedded into the electronic records within each of the participating GP practices at baseline and quarterly during the observation period at study months 10, 14, 18 and 22:<br>1. Number of patients having a reproductive review and care plan instigated<br>2. Number of patients engaged in the pre-pregnancy care pathway - referred to intermediate or hospital diabetes teams<br>3. Number of patients instigated on contraception