Approximately 50% of women of childbearing age in England are overweight or obese. With the known health risks this presents in pregnancy to mother and child, services need interventions to support women planning a pregnancy with weight loss. Current weight loss interventions in pregnancy do not make enough difference and so attention has turned to interventions before the woman becomes pregnant (pre-pregnancy).
This is not a group that services could specifically identify, with the exception of women using long-acting reversible contraception (LARC) such as the intrauterine device (coil) or sub-dermal implants, who need them removed by a GP or Sexual Health Practitioner (clinician) before they can become pregnant.
The aim of this study is to discover if it is possible to do a research study that asks women who are overweight/obese to delay LARC removal and take part in a pre-pregnancy weight loss intervention. From the CPRD data we want to determine how many women request a LARC removal each year and if it is possible to identify if they are overweight/obese.
The Plan-it study is made of two work-packages (WP); only the first is relevant to this application WP1 will use routine data to determine the number of LARC removals and outcomes of this potential participant population. This will provide an estimate for a sample size for a future trial in this patient population.
WP2 focuses on finding out the views of women and clinicians about this type of intervention and has separate ethical approval to conduct this research.
Work-package 1 will use routine data from CPRD relating to women attending for LARC removal.
The tasks are to set up access to anonymised data in order to:
- understand the pattern of LARC use to identify opportunities to intervene;
- report the annual number of women in the UK requesting removal of LARC without replacing it with an alternative prescribed contraception;
- determine the numbers of women requesting LARC removal who subsequently become pregnant who would be eligible to recruit to a weight loss intervention study
- determine the number of events in GP and hospital records to explore time from LARC removal to conception or appointments relating to difficulties conceiving (if possible).
Inclusion Criteria:
Women of reproductive age (16-48 years old) who have a LARC use/removal Read Code during 01JAN2009-31DEC2018.
Using CPRD data, it will be possible to map the time from LARC removal to conception (the estimated start date of pregnancy, attendance for a pregnancy scan and the first antenatal clinic visit), birth, then further contraception pattern. It will not be possible to definitively know from the routine data if a LARC was removed with the intention to start a family and therefore by following up patients, this will provide more insight with regards to their assumed motivation for LARC removal. We will examine the time between LARC removal and conception to see if a natural cut off exists. Using this cut off and in lieu of any events after LARC removal that would indicate that it was NOT for the purpose of planning a pregnancy (such as starting another form of contraception) it will be assumed that if a participant becomes pregnant in a certain period of follow-up allowed by the datasets, that LARC removal was for the purpose of planning a pregnancy. This will inform the numbers of potential participants available to take part in a future trial.
Specific to the CPRD workpackage:
Rates of women in the UK who request LARC removal and subsequently have a pregnancy (using routine data).
Identification of opportunities to intervene in preconception pathway (rates of LARC removal by month / year, overall numbers of women consulting for LARC removal).
Sue Channon - Chief Investigator - Cardiff University
Fiona Lugg-Widger - Corresponding Applicant - Cardiff University
Elinor Coulman - Collaborator - Cardiff University
Freya Davies - Collaborator - Cardiff University
Hywel M. Jones - Collaborator - Cardiff University
Mandy Lau - Collaborator - Cardiff University
Rebecca Cannings-John - Collaborator - Cardiff University
Zoe Couzens - Collaborator - National Public Health Service for Wales
HES Diagnostic Imaging Dataset;HES Outpatient;Pregnancy Register