Contraception and Pregnancy in Diabetes Mellitus
Conditions: Diabetes Mellitus, Type 1, Contraception
Sponsor: Imperial College London

 
 
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CAPRE-DM 
 
 
 
 
 
Contraception and Pregnancy in Diabetes Mellitus 
 
 
 
 
V1.1 
 
 
 
 
 
MAIN SPONSOR:  
 
 
Imperial College London 
FUNDERS:  
 
 
 
N/A 
STUDY COORDINATION CENTRE: 
Imperial College London 
 
IRAS Project ID:  
 
 
274613 
REC reference:   
 
 
20/NE/0081 
 
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Study Management Group 
 
Chief Investigator:  
 
Dr Rochan Agha-Jaffar (ICHT) 
 
Co-investigators:  
 
Dr Rebecca Scott (ICHT) 
 
Statistician:  
 
 
Dr Ian Godsland (ICL) 
 
Study Management:   
Ms Maria Thomas (ICL) 
 
 
Study Coordination Centre  
 
For general queries, supply of study documentation, and collection of data, please contact: 
 
Study Coordinator: Maria Thomas 
Address: Department of Metabolism, Digestion and Reproduction 
Imperial College London, 
Hammersmith Hospital, Commonwealth Building, Level 7, Room 7.S7 
Du Cane Road, White city, London, W12 0NN 
 
 
 
 
Tel: 020 7594 8995   
 
 
 
 
E-mail:  m.thomas@imperial.ac.uk 
 
 
Clinical Queries 
 
Clinical queries should be directed to Dr Rochan Agha-Jaffar who will direct the query to the 
appropriate person. 
 
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further information 
regarding the sponsorship conditions, please contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 9459/ 0207 594 1862 
http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice  
 
 
This protocol describes the CAPRE-DM study and provides information about procedures for entering 
participants.  Every care was taken in its drafting, but corrections or amendments may be necessary. 
These will be circulated to investigators in the study.  Problems relating to this study should be referred, 
in the first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the UK Policy Frame Work for Health and Social Care 
Research. It will be conducted in compliance with the protocol, the Data Protection Act and other 
regulatory requirements as appropriate.  
 
 
 

 
 
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Table of Contents                                                             Page No 
1. 
INTRODUCTION 
6 
1.1 
BACKGROUND 
6 
2.  STUDY OBJECTIVES 
7 
3.  STUDY DESIGN 
8 
3.1 
STUDY OUTCOME MEASURES 
8 
4. 
PARTICIPANT ENTRY 
9 
4.1 
PRE-REGISTRATION EVALUATIONS 
9 
4.2 
INCLUSION CRITERIA 
9 
4.2 
EXCLUSION CRITERIA 
9 
4.3 
WITHDRAWAL CRITERIA 
9 
5. 
ADVERSE EVENTS 
10 
5.1 
DEFINITIONS 
10 
5.2 
REPORTING PROCEDURES 
10 
6. 
ASSESSMENT AND FOLLOW-UP 
12 
7. 
STATISTICS AND DATA ANALYSIS 
14 
8. 
REGULATORY ISSUES 
15 
8.1 
ETHICS APPROVAL 
15 
8.2 
CONSENT 
15 
8.3 
CONFIDENTIALITY 
15 
8.4 
INDEMNITY 
15 
8.5 
SPONSOR 
15 
8.6 
FUNDING 
15 
8.7 
AUDITS 
15 
9. 
STUDY MANAGEMENT 
16 
10. 
PUBLICATION POLICY 
17 
11. 
REFERENCES 
18 
12. APPENDICES 
19 
APPENDIX 1. 
STUDY QUESTIONNAIRE 
19 
APPENDIX 2. 
ELECTRONIC HEALTH RECORD DATA SHEET 
ERROR! BOOKMARK NOT DEFINED. 
APPENDIX 3. DATA FLOW MAPPING 
19 
 
 
 

 
 
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GLOSSARY OF ABBREVIATIONS 
T1DM 
Type 1 Diabetes Mellitus 
T2DM 
Type 2 Diabetes Mellitus 
DM 
Diabetes Mellitus 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
KEYWORDS 
Diabetes Mellitus, Pregnancy, Women, Knowledge 
 
 
 
 
 
 

 
 
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STUDY SUMMARY 
 
TITLE Contraception and pregnancy in diabetes mellitus 
DESIGN Non-interventional, Cross-sectional study 
AIMS To examine the knowledge base women of reproductive age with diabetes 
have regarding contraception and pregnancy 
OUTCOME MEASURES Quantitative and qualitative questionnaires 
POPULATION n=100 
ELIGIBILITY Women of reproductive age (18-52) with diabetes 
DURATION 1 hour per participant, 5 months total 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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1. 
INTRODUCTION  
 
1.1 
Background 
 
Worldwide, 44% of pregnancies are unplanned (Bearak et al. 2018); in the UK 45% of 
pregnancies and one third of births are unplanned (Public Health England). 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 (Gnoth et al. 2003; Jensen et al. 2001).  
 
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 (Weissgerber & Mudd 2015; Temple et al 2001; Alexopoulos et al 2019).  
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 (Ludvigsson et al, 2018; 
Jensen et al 2009; Jensen et al 2004). 
 
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 
(Cartwright et al; 2009). 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 (Murphy et al; 2010). 
The reasons for this were multifactorial, including falling pregnant faster than expected, and 
pervious poor interactions with healthcare professionals. 
 
 
1.2 
Rationale for current study 
 
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. 
 
 
 
 

 
 
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2.  STUDY OBJECTIVES 
 
Primary Objective 
 
• 
To establish what knowledge women of childbearing age with diabetes have of  
o The risks and management of diabetes in pregnancy 
o The effect of diabetes on fertility 
o What forms of contraception women with diabetes use 
Secondary Objective 
• 
To describe the typical diabetes treatment regimes in women with diabetes of 
reproductive age.  
• 
To determine the overall diabetes control in women with diabetes of reproductive 
age. 
• 
To examine the number of women of reproductive age who have diabetes-related 
complications. 
 

 
 
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3.  STUDY DESIGN 
 
Non-interventional, cross-sectional questionnaire study in women of child-bearing age  
1 hours per participant, 6 months total  
n=100 participants total 
 
3.1 
Study Outcome Measures 
 
1. Quantitative data: 
 
• 
Number of women planning a pregnancy within the next year 
• 
Invitation to and attendance at pre-conception counselling 
• 
Current contraceptive choices 
• 
Knowledge of effect of diabetes on fertility  
• 
Number of women who have had the importance of a planned pregnancy explained 
to them 
 
2. Descriptive data 
• 
Women’s knowledge of the risks to the mother during pregnancy if the mother has 
diabetes 
• 
Women’s knowledge of the risks to the fetus during pregnancy if the mother has 
diabetes 
Additional baseline participant data: 
• 
Age 
• 
Ethnicity 
• 
Number of previous pregnancies 
• 
Type of diabetes 
• 
Length of diabetes 
• 
Current diabetes treatment 
• 
Diabetes complications: nephropathy, neuropathy, retinopathy, cardiovascular 
disease 
• 
Recent HbA1C 
• 
Other medical conditions 
• 
Other medications 
 
 
 
 

 
 
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4. 
PARTICIPANT ENTRY  
 
4.1 
Pre-registration evaluations  
 
Potential participants will be identified by the clinical diabetes team from the list of people who 
attend the diabetes clinics at Imperial College Healthcare NHS Trust. 
 
4.2 
Inclusion Criteria 
• 
Women aged 18-52 years (reproductive age) who are not currently pregnant 
• 
Previous diagnosis of Diabetes Mellitus  
 
4.2 
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 
 
4.3 
Withdrawal criteria 
• 
Loss of capacity to give informed consent 
• 
Investigator initiated discontinuation of study due to participation concerns 
 
Withdrawal will be immediate, and participants will be followed up in the appropriate out-
patient diabetes clinic at their usual appointments. 
 
If a participant, who has given informed consent, loses capacity to consent during the study 
the participant will be withdrawn from the study. Identifiable data already collected with 
consent will be retained and used in the study. No further data would be collected or any other 
research procedures carried out on or in relation to the participant. 
 
 
 
 

 
 
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5. 
ADVERSE EVENTS 
 
5.1 
Definitions   
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect 
that: 
• 
Results in death 
• 
Is life-threatening – refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
• 
Requires 
hospitalisation, 
or 
prolongation 
of 
existing 
inpatients’ 
hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of 
the other outcomes listed in the definition above, should also be considered serious. 
 
5.2 
Reporting Procedures 
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
5.2.1 Non serious AEs 
All such events, whether expected or not, should be recorded.   
 
5.2.2 Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours.  
However, relapse and death due to diabetes mellitus, and hospitalisations for elective 
treatment of a pre-existing condition do not need reporting as SAEs. 
 
All SAEs should be reported to the <name of REC> where in the opinion of the Chief 
Investigator, the event was: 
• 
‘related’, i.e. resulted from the administration of any of the research procedures; 
and 
• 
‘unexpected’, i.e. an event that is not listed in the protocol as an expected 
occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
 

 
 
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Contact details for reporting SAEs 
jrco@imperial.ac.uk 
CI email (and contact details below) 
Fax: 0202 312 1563 for attention Dr Rochan Agha-Jaffar  
Please send SAE forms to: Department of Diabetes and Endocrinology, St Mary’s 
Hospital, Praed Street, London W2 1NY 
Tel: 0203 312 1253 (Mon to Fri 09.00 – 17.00) 
 
 
 

 
 
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6. 
ASSESSMENT AND FOLLOW-UP  
 
This study will consist of completing a questionnaire.  This should take no more than 1 hour 
to complete by the participant at a time and location convenient to them.  
 
All eligible participants will be identified by the clinical care team.  A list of potential 
participants will be identified from the database of all people who attend the diabetes clinics 
at Imperial College Healthcare NHS Trust (subsequently known as the participant database).   
 
Potential participants will be contacted in one of 3 ways by the clinical team: 
 
a) Participants whose emails are available on Cerner will be contacted by email by a 
member of their direct care team (who is also part of the research team). The email 
will include the PIS and a link to Qualtrics (an online data collection platform which is 
supported by the college). Informed consent will be taken via this platform with 
questionnaires to follow (only accessible if participant has consented to all clauses and 
signed electronically). Participants will be able to arrange a phone call with the 
research team to discuss any issues or concerns before signing the consent if they 
wish.  Participants will be provided with a unique code to enable researchers to link 
their questionnaire data with their medical records. This will be different to the study 
code and which will be assigned to participants after consent in order of enrolment. 
b) For potential participants whose emails are not available or who prefer a hard copy 
approach, study packs, including the patient information sheet, consent form and 
questionnaire will be sent by post for completion at home, and returned in a pre-paid 
addressed envelope to the research team.  
c) Patients who are seen in clinic by either the diabetes team will be approached by their 
clinical team about participating in the study. Those who are interested will then be 
provided with a consent form and study questionnaire which can either be completed 
and returned to the research team whilst in the clinic or taken home and returned in a 
stamped addressed envelope at the participant’s convenience. 
 In all cases, the research team will make blank study packs (including the consent form, 
patient information sheet and questionnaire) which can be addressed to the individual 
woman by the clinical team. All women will be asked to return the questionnaire by the end 
of the study for inclusion in the study analysis. 
 
Within the patient information sheet there will be contact details for the research team, 
should the participant wish to discuss the study and obtain any further details.   
 
Once returned, the pseudonymised questionnaire data will be recorded in a password 
encrypted database on an Imperial College Healthcare NHS Trust computer (subsequently 
known as the results database). Informed consent will be filed in the trial master file. . Data 
from Qualtrics will be downloaded in a PDF format on either an ICL or ICHT computer and 
printed for hard copy records. Questionnaire scoring data will be pulled from Qualtrics in a 

 
 
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pseudonymised format and saved on either an ICL or ICHT computer within an encrypted, 
password protected document. 
 
Once informed consent has been provided, The research team will then review the 
electronic health records of those participants who have consented to record biochemical 
data, medical history and baseline demographics. This data will be recorded in 
pseudonymised form in the results database. 
 
In all cases, no samples are taken and all data will be pseudonymised. No follow up outside 
of usual care will be provided. 
 
End of study will be defined as last subject last visit (LSLV). 
 
 
 
 

 
 
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7. 
STATISTICS AND DATA ANALYSIS 
 
Approximately 100 potential participants will be identified from the list of persons who attend 
the Imperial College Healthcare NHS Trust diabetes clinics.  This is based on the known 
total number of people who attend these clinics (approximately 2000), assuming that 50% 
will be women and 50% of these will be of reproductive age. All potential participants will be 
sent the study pack.  A response rate of 10-20% is assumed following previous 
questionnaire studies undertaken at Imperial College of patient populations. 
 
This study contains both descriptive and quantifiable data.  The quantitative outcomes may 
be either ordinal or categorical, and proportions tests, including Chi squared tests, t-tests 
and ANOVAs will be used to determine differences between these outcomes.  
 
The descriptive data will be tabulated and presented as such without statistical analysis.  
 
All personal details will be sent via encrypted email (nhs.net). 
Record linking participant information to study ID will be stored securely on an Imperial 
College NHS trust Computer. All study data will be stored in a pseudonymised format in an 
encrypted database on an Imperial College NHS trust computer. 
Direct quotations may be published in anonymous fashion. Care will be taken to ensure no 
other incidental details (such as ethnicity or age) will be associated with the quotation, in 
order to ensure anonymity. The NHS Code of Confidentiality will be followed at all times. All 
data is to be stored in a pseudonymised form by using study codes for de-identification of 
participants.  Examples of such a code includes: CAPRE-DM 0001 (assigned in order of 
enrolment). Identifiable Personal data will be kept in files in a locked office within Imperial 
College Healthcare NHS Trust, accessible only by the research/clinical team. 
Pseudonymised data will be stored in a password encrypted spreadsheet on ICHT 
computers, accessible only by the research team. 
 
Data and all appropriate documentation will be pseudonymised and stored for a minimum of 
10 years after the completion of the study in line with Imperial College policy.   
 
 
 

 
 
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8. 
REGULATORY ISSUES 
 
8.1 
Ethics approval 
The Study Coordination Centre has obtained approval from the xxx Research Ethics 
Committee (REC) and Health Regulator Authority (HRA). The study must also receive 
confirmation of capacity and capability from each participating NHS Trust before accepting 
participants into the study or any research activity is carried out. The study will be conducted 
in accordance with the recommendations for physicians involved in research on human 
subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. 
 
8.2 
Consent  
Consent to enter the study must be sought from each participant only after a full explanation 
has been given, an information leaflet offered and time allowed for consideration.  Signed 
participant consent should be obtained.  The right of the participant to refuse to participate 
without giving reasons must be respected.  After the participant has entered the study the 
clinician remains free to give alternative treatment to that specified in the protocol at any stage 
if he/she feels it is in the participant’s best interest, but the reasons for doing so should be 
recorded.  In these cases the participants remain within the study for the purposes of follow-
up and data analysis.  All participants are free to withdraw at any time from the protocol 
treatment without giving reasons and without prejudicing further treatment. 
 
8.3 
Confidentiality 
Anonymised quotes may be used in publications if the participant has given written informed 
consent. The Chief Investigator will preserve the confidentiality of participants taking part in 
the study and is registered under the Data Protection Act. 
 
8.4 
Indemnity 
Imperial College London holds negligent harm and non-negligent harm insurance policies 
which apply to this study. 
 
8.5 
Sponsor 
Imperial College London will act as the main Sponsor for this study.  Delegated responsibilities 
will be assigned to the NHS trusts taking part in this study.   
 
8.6 
Funding 
The study is funded by the Imperial College Diabetes team. No payments will be made to 
participants or investigators in this study.  
 
8.7 
Audits  
The study may be subject to inspection and audit by Imperial College London under their remit 
as sponsor and other regulatory bodies to ensure adherence to GCP and the UK Policy Frame 
Work for Health and Social Care Research.  
 
 
 
 

 
 
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9. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be co-ordinated through Dr Rochan Agha-Jaffar.   
 
 
 
 
 
 

 
 
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10. 
PUBLICATION POLICY 
 
The study will be registered on the clinicaltrials.gov system and results will be disseminated 
by peer reviewed scientific journals, internal report, conference presentation and publication 
on websites. No identifiable personal data will be published. Anonymised quotes may be 
included in publications if the participant has given informed written consent. All anthropometry 
and personal clinical data will be expressed as mean/ median and spread of the population in 
the study. All participants will be informed of the results by letter at the conclusion of the study 
and details of any publications that arise from the study will be disseminated to participants.   
 
 
 
 

 
 
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11. 
REFERENCES 
1. Bearak et al Lancet Glob Health. 2018 Apr;6(4):e380-e389.  Global, regional, 
and subregional trends in unintended pregnancy and 
its outcomes from 1990 to 2014: estimates from a Bayesian hierarchical model. 
2. https://www.gov.uk/government/publications/health-matters-reproductive-health-and-
pregnancy-planning/health-matters-reproductive-health-and-pregnancy-planning 
3. Gnoth et al. Human reproduction.  2003,18 (9), 1959–1966. Time to pregnancy: 
results of the German prospective study and impact on the management of infertility.  
4. Jensen et al. Human reproduction. 2001, 16(12), 2607-2704. Regional differences in 
waiting time to pregnancy among fertile couples from four European cities.  
5. Ludvigsson et al. BMJ. 2018 362:K2638. Periconception glycaemic control in women 
with type 1 diabetes and risk of major birth defects: population based cohort study in 
Sweden. 
6. Jensen et al. Diabetes Care 2009 Jun; 32(6): 1046-1048. Peri-conceptional A1C and 
risk fo serious adverse pregnancy outcome in 933 women with Type 1 Diabetes.  
7. Jensen et al. Diabetes Care 2004.27(12): 2819-2823. Outcomes in type 1 diabetic 
pregnancies: a nationwide, population-based study. 
8. Weissgerber & Mudd.  Curr Diab Rep. 2015, 15(3): 570  Pre-eclampsia and 
Diabetes.  
9. Temple et al. Diabet Med 2001,18(7), 573-577. Impact of pregancny on the 
progression of diabetic retinopathy in type 1 diabetes.  
10. Alexopoulos et al. JAMA 2019, 321 (18): 1811-1819. Management of pre-existing 
diabetes in pregnancy: a review.  
11. NICE guidance NG3 
12. National Diabetes in Pregnancy Audit https://digital.nhs.uk/data-and-
information/publications/statistical/national-pregnancy-in-diabetes-audit/national-
pregnancy-in-diabetes-annual-report-2018 
13. Cartwright et al. Practical Diabetes International 2009. What do women with diabetes 
know about pregnancy and contraception? 
14. Murphy et al. Diabetic Medicine. 2010.  Personal experiences of women with 
diabetes who do not attend pre-pregnancy care. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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12. APPENDICES 
 
Appendix 1. Study Questionnaires (attached separately) 
 
Appendix 2.  Data Flow Mapping