The prevalence of autoimmune conditions among pregnant women and bidirectional association with pregnancy complications.

Study type
Protocol
Date of Approval
Study reference ID
23_002650
Lay Summary

Autoimmune conditions happen when the body's defense system mistakenly attacks its own normal cells, thinking they are invaders. This tends to occur more often in women during their childbearing years. These conditions have been connected to problems during pregnancy. Also,some studies suggest that women who have complications in pregnancy might be at a higher risk of developing autoimmune conditions later on. This study wants to look into this two-way relationship.
Firstly we will check how common autoimmune conditions are in pregnant women by looking at their health record data. then we will also try to figure out how often women with autoimmune conditions have problems during pregnancy. And to understand how autoimmune conditions might affect the health of both the mother and the baby during pregnancy. Additionally, the study will explore whether women who have pregnancy complications are more likely to develop autoimmune conditions in the future. This study will help health professional, patients and families plan the pregnancy care particularly in women with the autoimmune conditions. And also help develop post pregnancy plan for women with pregnancy complications so that they do not develop the related autoimmune conditions.

Technical Summary

The aim of this study is to investigate this bidirectional association of pregnancy complications and autoimmune conditions Firstly we will estimate the prevalence of autoimmune conditions among pregnant women within the CPRD Pregnancy Register. A list of 15 common and key autoimmune conditions during pregnancy have been determined through a literature search and stakeholder workshop. These AI conditions will be ascertained by diagnostic codes.Then the study will be divided into four parts
Study 1- Using the CPRD Pregnancy Register, cohort of pregnancies will be established. Then estimate the incidence of pregnancy complications in women with pre-existing autoimmune conditions of interest compared to women without that autoimmune condition. These pregnancy complications will be ascertained by diagnostic codes
Study 2-Using linked HES data, cohort of delivery records will be ascertained based on OPCS delivery codes. We will estimate the incidence of obstetric complications in women with pre-existing AI conditions. These obstetric complications will be ascertained by both primary care and linked HES records.
Study 3-Using mother-baby linked data, cohort of babies born and linked to mothers within the CPRD Pregnancy Register will be established. We will estimate the risk of offspring outcomes among women with autoimmune conditions during pregnancy.
Study 4- Then we will investigate whether women who experience pregnancy complications are more likely to develop AI conditions.These pregnancy complications will be ascertained by both primary care and linked HES records.

A matrix of odds ratio will be tabulated quantifying the association between each of autoimmune conditions/pregnancy complications and outcome of interest based on a series of logistic regression models and will be adjusted for relevant covariates. This study will ascertain the potential bidirectional association of pregnancy complications/adverse pregnancy outcomes with autoimmune conditions. and will help clinicians to develop appropriate strategies or suitable healthcare pathways to avoid the occurrence of these outcomes.

Health Outcomes to be Measured

Primary aim: Prevalence of autoimmune conditions in pregnant women within CPRD Pregnancy Register

Secondary aims: The outcomes used for each of the studies are as follows:

Study 1-Pregnancy complications (first trimester, second trimester mainly)
1. Miscarriage
2. Hyperemesis gravidarum
3. Ectopic pregnancy
4. Hypertensive disorders of Pregnancy (Gestational hypertension, Pre-eclampsia, Eclampsia, HELLP)
5. Gestational diabetes mellitus
6. Post-partum depression
7. Puerperal psychosis

Study 2-Obstetric outcomes
1. Obstetric haemorrhage (postpartum)
2. Mode of Birth Caesarean delivery (HES), Instrumental
3. Perineal trauma-3rd and 4th degree
4. Stillbirth
5. Placental abruption
6. Pre-term birth
7. Small for gestational age

Study 3-Adverse offspring outcomes
1. Major congenital abnormalities
2. Neurodevelopmental disorders

Study 4- Addison’s disease, alopecia areata, axial spondyloarthropathy (including ankylosing spondylitis, rheumatoid arthritis), coeliac disease, inflammatory bowel disease (including Crohn’s disease, ulcerative colitis), multiple sclerosis, myasthenia gravis, psoriasis, psoriatic arthritis, Sjogren’s syndrome, systemic lupus erythematosus, systemic sclerosis,, thyroid autoimmunity (including Grave’s disease, Hashimoto’s Disease), Type 1 Diabetes mellitus, vitiligo.

Collaborators

Megha Singh - Chief Investigator - University of Birmingham
Megha Singh - Corresponding Applicant - University of Birmingham
Francesca Crowe - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham

Former Collaborators

Anuradhaa Subramanian - Collaborator - University of Birmingham
Amy Shackleford - Collaborator - University of Birmingham
Francesca Crowe - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Krishnarajah Nirantharakumar - Collaborator - University of Birmingham

Linkages

HES Admitted Patient Care;Patient Level Index of Multiple Deprivation;CPRD Aurum Mother-Baby Link;CPRD Aurum Pregnancy Register;CPRD GOLD Mother-Baby Link;CPRD GOLD Pregnancy Register