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Pregnancy outcomes after stoma surgery for inflammatory bowel disease: The results of a retrospective multicentre audit

Abstract Aim There is a paucity of data on pregnancies in women with stomas due to inflammatory bowel disease (IBD). The aim of this study was to assess stoma, IBD, obstetric and neonatal outcomes in pregnant patients with IBD and a stoma. Method Multicentre retrospective audit in 15 UK hospitals. Pregnancy, stoma and neonatal outcomes were elicited from routinely collected hospital records. Results Data on 82 pregnancies from 77 patients (mean age 31.4 years, 60.9% Crohn's disease, 35.4% ulcerative colitis, 3.6% IBD‐U) were included. Stoma types included ileostomy in 72 (88%) and colostomy in 10 (12%) women. There was one reported miscarriage, one still birth and 80 live births. Delivery occurred in 58 cases by caesarean section (CS), of which 44 were performed electively and 14 as emergency CS. The overall CS rate was 73%. Premature delivery before week 37 occurred in 19% and birth weight <2,500 g in 17%. Significant stoma related complications occurred during 20 (24%) pregnancies and included stoma prolapse in nine cases (2 required surgery), parastomal hernias in three cases (2 required surgery) and small bowel obstructions in seven cases (3 required surgery). Conclusions Pregnancy for women who previously had stoma formation for IBD is associated with higher rates of caesarean section and stoma complications. Future prospective studies should capture data, including patient reported outcomes, to gather a full picture on the impact of pregnancy after stoma surgery for IBD.


Participants
Female patients who had a confirmed diagnosis of IBD who had experienced pregnancy following stoma formation (ileostomy or colostomy) between 2014 and 2020 were included in the study. We excluded patients with stomas for reasons other than IBD and those who had their stoma reversed prior to pregnancy. Of 15 centres taking part, there were 11 specialist University Teaching Hospitals and four District General Hospitals.

Data collection
Items included in the data collection were agreed by the multidisciplinary study team with significant input from expert patients. Data on age, diagnosis, extent and behaviour of disease, type of stoma and details of previous surgery were collected. Disease activity during pregnancy and postpartum activity were recorded by physician global assessment (PGA) and reported as the worst disease activity during any trimester. Medication exposure during pregnancy was recorded for use of mesalazine, steroids, biologics and thiopurines.
Data on whether conception was natural or assisted was collected, alongside data on week of delivery and delivery methods. Obstetric, IBD and serious stoma complications (herniation, prolapse, obstruction or need for further surgery on the stoma) within 30 days of delivery were also collected, as were data on stoma complications during pregnancy and whether surgical intervention was needed.
Data was collected from local IBD-pregnancy databases and/or clinical charts.
Sites were required to submit pseudoanonymised data via the secure nhs.net email system and no raw patient data left the National Health Service.

Outcomes and definitions
The coprimary endpoints were stoma complications and obstetric mode of delivery. Further obstetric outcomes collected were week of gestation, birth weight, and congenital abnormalities. In accordance with national guidance premature delivery was defined as birth before 37 weeks of gestation and birth weight <2,500 g.
IBD outcomes collected were flares defined as need for changes in medical therapy, and high output from the stoma. These were reviewed and categorised by gastroenterology members of the research team.
Surgical outcomes collected were intestinal obstruction, stoma prolapse, stoma herniation, and need for further stoma surgery.

What does this paper add to the literature?
This retrospective audit is the only comprehensive modern report of pregnancy outcomes following stoma surgery for inflammatory bowel disease. This paper highlights the need for patients to be counselled appropriately with regards to the method of delivery and the potential complications of pregnancy with a stoma. These were reviewed and categorised by surgical members of the research team.

Patient and public involvement
This study was conceived following a research sandpit hosted by the Bowel Disease Research Foundation (now known as Bowel Research UK) on behalf of IA (Ileostomy and Internal Pouch Association) and the Kingston Trust. The Chief Investigator is a patient and the study steering group includes a patient representative who has personal experience of pregnancy after stoma surgery for IBD.

Analysis
Demographic and disease characteristics were analysed by descriptive statistics. Pregnancy outcomes were presented on a per pregnancy rather than per patient basis unless otherwise specified.

Comparative analysis used Fisher's exact test for categorical and
Student's t-test for noncategorical data. The analysis was performed with SPSS 25 (IBM). Significance was set at 5% (p < 0.05). As an exploratory cohort study, no formal sample size calculation was performed.

Role of the funding source
The study funders had no role in the study design, collection, analysis and interpretation of data, or in the writing of this manuscript.

RE SULTS
There were 82 pregnancies in 77 women with a mean age of 31.4 years (range 20-39 years, Table 1). Of these 50 (60.9%) had a diagnosis of Crohn's disease (CD), 29 (35.4%) ulcerative colitis (UC), and three (3.6%) IBD-unclassified (IBD-U). One woman was a current cigarette smoker, while 13 were previous smokers. Medical treatments included five treated with mesalazine, 17 with thiopurines and 29 on biologics. Biologics were stopped in 20 of 29 (69%) cases at a mean of 25 weeks' gestation. In 45 patients no medical therapy for IBD was required during pregnancy. Highest recorded IBD disease activity during pregnancy was remission in 48 (59%), mild in 11 (13%), moderate in 12 (15%) and severe in six (7%) cases (no data available for 5 cases).
Active perianal CD was present in 10 patients (12%), while 18 (22%) had a history of previous perianal CD. Table 2 sets out the main outcomes by type of IBD.

Stoma complications
In 20 (24%) pregnancies, serious stoma-related complications occurred. Prolapse of the stoma occurred in nine (11%) cases, of which two required an operation to correct the prolapse during pregnancy.
New onset of parastomal hernia was reported in three (4%) pregnancies, of which two required surgical operative management during pregnancy. Small bowel obstruction occurred in seven (9%) cases.
One of these was just proximal to the stoma and resolved with con-

Birth outcomes
Of 82 pregnancies, 77 were naturally conceived and five were conceived using assisted fertility techniques. We recorded one miscarriage at 5 weeks and a still birth at 30 weeks' gestation.
There were 81 infants (1 twin pregnancy) born at mean gestation of 37 weeks (range 29-41 weeks) with delivery before week 37 occurring in 14 of 74 documented (19%) cases. Mean birth weight was 3,030 g (standard deviation 720 g) with weight <2,500 g at birth in 13 of 75 documented cases (17%). A single case of congenital malformation (undeveloped larynx, undescended testes) was recorded in a case exposed to biologic therapy.

Obstetric complications
Postpartum haemorrhage occurred in six (7.5%) cases, of which one required surgical intervention. Bladder injuries during CS occurred in three patients. There were two cases of postpartum acute renal failure, two postoperative wound infection, and one postoperative collection requiring radiological drainage. During two CS deliveries, significant adhesions were encountered that required adhesiolysis.

Inflammatory bowel disease complications
Complications relating to IBD occurred in 11 cases (13%). These included two flares requiring change of medical treatment, one case of a high output stoma, one of perianal sepsis and one with subacute obstruction after emergency caesarean section that responded to conservative management.

DISCUSS ION
Pregnancy after stoma surgery for IBD can be a difficult decision for many women. There is little published research about the impact of pregnancy on stoma function, stoma related complications, obstetric and neonatal outcomes. This audit is the largest study of pregnancy outcomes after stoma surgery for IBD. A systematic review (PROSPERO CRD4201919 54521) undertaken as part of the wider PAPooSE study found one paper on eight cases published in 2018 [14]. We have shown that while pregnancy following stoma surgery for IBD is possible, it is associated with significant risk for CS and for stoma related complications. also possible that some clinicians and patients believed CS to be the delivery method of choice for most pregnancies with IBD related stomas. Reassuringly, the rate of emergency CS in our cohort is similar to that seen in the general population [15].
Given our reported CS rate of 73%, women should be counselled about increased risk of planned CS after IBD surgery with a stoma to facilitate early conversations with their obstetric team about planned CS to avoid further complications. Current guidance [12,[17][18][19] and patient information leaflets should be updated to reflect this risk in the subset of IBD patients with a stoma while highlighting that in general most women with IBD can deliver by vaginal delivery [12,20]. We report three cases of bladder injury during CS, which is much higher than the risk in the general population ranging from 0.1% to 0.3% [21,22]. It is likely that adhesions from previous pelvic surgery increase risk of bladder injury during CS in all women with IBD and does not specifically relate to the presence of a stoma.
Our data shows that women who have a pregnancy after stoma surgery for IBD have slightly worse infant outcomes than the general population, but overall infant outcomes were good. Nineteen per cent of births were before 37 weeks' gestation compared to 7.3% of all deliveries in England and 17% of babies had a birth weight of less than 2,500 g (World Health Organisation definition of low birth weight) compared to 3% in England [15]. This increase in premature delivery and low birth weight may perhaps be driven by IBD disease activity, which would be best assessed with objective measures in a prospective study. It is also possible that altered abdominopelvic anatomy and metabolic deficiencies may also contribute.
There was a high rate of serious stoma complications at 24%, though most were managed conservatively. Patient education early in pregnancy should focus on recognition of stoma complications to allow for timely assessment and where needed intervention.
Clinicians and stoma care teams should be aware of the one in four risk of pregnant IBD patients experiencing stoma related complications. Close involvement of the patient's stoma care team should be sought as they are best placed to advise on potential mild to moderate stomal complications and how to manage these during pregnancy, and specifically advise on need to change stoma appliances or application. Interestingly, we found that all stoma complications occurred in patients with ileostomies but not in those with colostomies. Further studies are required to explore this finding and the potential for associated pathophysiology.

DATA AVA I L A B I L I T Y S TAT E M E N T
Summary data will be available on publication (with no end date) upon reasonable request to Christian Selinger (christian.selinger@ web.de).