Known knowns, unknown unknowns and everything in-between

Letter to the Editor, BJOG Exchange

A document by Adrian Gaspar. Click on the document to view its contents.

Mini-commentary on BJOG-20-1239.R3: Intramuscular oxytocin versus Syntometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: a randomised double blinded clinical trial of effectiveness, side effects and quality of life

Objective To develop a Core Outcome Set (COS) for treatment of perinatal depression Design Systematic overview of outcomes reported in the literature and consensus development study using a Delphi survey and modified nominal group technique. Setting International. Population Two hundred and twenty-two participants, representing thirteen countries. Methods A systematic overview of outcomes reported in recently published research, a two-round Delphi survey, a consensus meeting at which the final COS was decided. Main results In the literature search, 1772 abstracts were identified and evaluated, 284 papers/protocols were assessed in full and 165 studies were finally included in the review. In all, 106 outcomes were identified and thus included in the Delphi survey. 222 participants registered for the first round of the Delphi survey and 151 (68%) responded. In the second round, 123 (55%) participants responded. The following 9 outcomes were agreed upon for inclusion in the final COS: self-assessed symptoms of depression, diagnosis of depression by a clinician, parent to infant bonding, self-assessed symptoms of anxiety, quality of life, satisfaction with intervention, suicidal thoughts, attempted or committed suicide, thoughts of harming the baby, and adverse events. Conclusions The relevant stakeholders prioritised outcomes and reached consensus on a COS comprising nine outcomes. We hope that this COS will contribute to consistency and uniformity of outcome selection and reporting in future clinical trials involving treatment of perinatal depression Funding This article is adapted from a report by SBU, which provided funding for the study. Keywords: perinatal depression, postpartum depression, antenatal depression, COS

Objective To compare the effectiveness, safety and acceptability of medical abortion before and after the introduction of no-test telemedicine Design Cohort study Setting The three main abortion providers in England Population All patients having an early medical abortion (comprising 85% of all medical abortions performed nationally) Methods Comparison of no-test telemedicine hybrid model vs. traditional model (blanket in-person provision including ultrasound), adjusted for baseline differences Main outcome measures Access: waiting time, gestation Effectiveness: successful medical abortion Safety: significant adverse events; ectopic pregnancy and late gestation Acceptability: Patient-reported outcomes Results 52,142 medical abortions were conducted, 29,984 in the telemedicine-hybrid cohort and 22,158 in the traditional cohort. Mean waiting times were 4.2 days shorter in the telemedicine-hybrid cohort and 40% were ≤6 weeks’ gestation vs. 25% in the traditional cohort (p<0.001). There was no difference in success rates (98.8% vs. 98.2%, p=1.0), nor in prevalence of serious adverse events (0.02% vs. 0.04%, p=0.557). Incidence of ectopic pregnancy was equivalent in both cohorts (0.2%, p=0.796); 0.04% of abortions appeared to have been provided after 10 weeks’ gestation with all completed safely at home. In the telemedicine-hybrid cohort, effectiveness was higher in the telemedicine group vs. the in-person group (99.2% vs. 98.1%, p<0.001). Acceptability was high (96% satisfied), 80% reported a future preference for telemedicine, and none reported that they were unable to consult in private using teleconsultation. Conclusions Medical abortion provided through a hybrid model that includes no-test telemedicine without ultrasound is effective, safe, acceptable, and improves access to care. Funding None

Letter to the Editor, BJOG Exchange

Objectives: to evaluate the effectiveness of uterine tamponade devices for atonic refractory postpartum haemorrhage (PPH) after vaginal birth, and the effect of including uterine tamponade devices in institutional protocols. Search strategy: databases in PubMed, EMBASE, CINAHL, LILACS and POPLINE. Study selection: randomised and non-randomised comparative studies. Outcomes: composite outcome including surgical interventions (artery ligations, uterine compressive sutures or hysterectomy) or maternal death, and hysterectomy. Results: all four included studies were at high risk of bias. The certainty of evidence rated as very low to low. One randomised study measured the effect of the the condom-catheter balloon compared to standard care and found unclear results for the composite outcome (RR 2.33, 95%CI 0.76-7.14) and hysterectomy (RR 4.14, 95%CI 0.48-35.93). Three comparative studies assessed the effect of including UBTs in institutional protocols. A stepped-wedge study suggested an increase in the composite outcome (RR 4.08, 95%CI 1.07-15.58), and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95%CI 0.11-1.03) and hysterectomy (RR 0.49, 95%CI 0.04-5.38) after the inclusion of Bakri balloon. The second non-randomized study found unclear effects on the composite outcome (RR 0.95, 95%CI 0.32-2.81) and hysterectomy (RR 1.84, 95%CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon. Conclusions: the effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting.

Objective: to describe the impact of COVID-19 on the management of patients with ectopic pregnancy. Design: a multicentre study comparing outcomes from a prospective cohort during the pandemic [Covid-ectopic pregnancy registry (CEPR)] compared to an historical pre-pandemic cohort [non-Covid ectopic pregnancy registry (NCEPR)]. Setting: five London university hospitals. Population and Methods: consecutive patients diagnosed clinically and/or radiologically with ectopic pregnancy (March/2020-Aug/2020) were entered into the CEPR and an exploratory matched analysis was performed comparing results to NCEPR patients (January/2019-June/2019). Main outcome measures: patient demographics, management (expectant, medical and surgical), length of treatment, number of hospital visits (non-surgical management), length of stay (surgical management) and 30-day complications. Results: 341 patients met inclusion: 162 CEPR and 179 NCEPR. A significantly higher percentage of women underwent non-surgical management versus surgical management in the CEPR versus NCEPR (58.6% [95/162] vs 72.6% [130/179]; p= 0.0084]. Amongst patients managed with expectant management the CEPR had a significantly lower mean number of hospital visits compared to NCEPR [3.6 [SD 1.4] vs 13.7 [SD 13.4], p= 0.0053]. Amongst patients managed with medical management, the CEPR had a significantly lower mean number of hospital visits [NCEPR 6.4 [SD 2.3] vs 8.8 [SD 3.9], p= 0.0014]. There was no observed difference in complication rates between cohorts. Conclusion: women were found to undergo significantly higher rates of non-surgical management during COVID-19 first wave vs NCEPR cohort. Women managed non-surgically in CPER cohort were also managed with fewer hospital attendances. This did not lead to an increase in observed complications rates.

Objective Post-menopausal nocturia is poorly understood. This study aimed to identify hormonal and lifestyle factors associated with nocturia and to understand the relative contribution of altered urine production and bladder storage dysfunction in women. Design, setting, population and methods Women ≥40 years presenting to public continence services were enrolled in a cross-sectional study. 153 participants completed a hormone status questionnaire, a validated nocturia causality screening tool and a 3-day bladder diary. Descriptive statistics and logistic regression models for nocturia severity and bladder diary parameters were computed. Results Overall, 91.5 % reported nocturia, 55% ≥2 /night. There was a difference of 167.5 mL (p<0.001) in nocturnal urine volume between women with nocturia ≥2 (median 736mL) vs less often (517mL). Significant predictors of self-reported disruptive nocturia were age (OR 1.04, 95%CI 1.002-1.073) and vitamin D supplementation (OR 2.33, 95%CI 1.11-4.91). Nocturnal polyuria was significantly more common with nocturia ≥2 compared to less often (p<0.002). 150 minutes of exercise per week was protective for nocturnal polyuria (OR 0.22, p=0.001). Nocturia index >1.3 was significantly predicted by age (OR 1.07, p<0.001), regular exercise (OR 0.41, p=0.036), day flushes (OR 4.00, p=0.013) and use of Vitamin D (OR 2.34, p=0.043). Maximum voided volumes were significantly lower with nocturia≥2 vs less often (night: 268ml vs 350mL; day: 200mL vs 290mL). Conclusions Bothersome nocturia in post-menopausal women is associated with changes to both nocturnal diuresis and bladder storage. Regular physical activity, prolapse reduction and oestrogen replacement may be adjunctive in managing bothersome nocturia in women.

Mini-commentary on BJOG-20-1841.R1: Cervical dilatation and preparation prior to outpatient hysteroscopy: A systematic-review and meta-analysis

A document by Mehreen Zaigham. Click on the document to view its contents.

BJOG-20-0640.R1 The evolving definition of pre-eclampsia

Objective To explore and describe what women who have given birth in Norway emphasise as important aspects of care during childbirth. Design The study is based on data from the Babies Born Better survey, version 2, a mixed-method online survey. Setting The maternity care system in Norway. Study population Women who gave birth in Norway between 2013 and 2018. Method Descriptive statistics were used to describe sample characteristics and to compare data from the B3 survey with national data from the MBRN, using SPSS® software (version 20). The open-ended questions were analysed with an inductive thematic analysis, using NVIVO 12® software. Main outcome measures Themes developed from two open-ended questions. Results The final sample included 8,401 women. There were no important differences between the sample population and the national population with respect to maternal age, marital status, parity, mode of birth and place of birth, except for the proportion of planned homebirths. Four themes and one overarching theme were identified; Compassionate and Respectful Care, A Family Focus, Continuity and Consistency, and Sense of Security, and the overarching theme Coherence in Childbearing. Conclusions Socio-cultural and psychological aspects of care are significant for women in childbirth, alongside physical and clinical factors. Caring for the woman implies caring for her partner and having a baby is about ‘becoming a family or expanding the family’. Childbirth is a continuous experience in women’s lives and continuity and consistency are important for women to maintain and promote a coherent experience.

BJOG Debate

Aim: To develop clinical algorithms for the assessment and management of slow progress of labour. Population: Low-risk singleton, term, pregnant women in labour. Setting: Institutional births in low- and middle-income countries. Search Strategy: We systematically reviewed the literature on normal labour progression, and guidance on clinical management of abnormally slow progression from 1 December 2015 to 1 December 2020. Case scenarios: We developed two clinical algorithms: one for abnormally slow labour progression and arrest during first and one for second stage. Conclusions: Identifying abnormal progress of labour is often challenging. These algorithms may help to reduce misdiagnosis.

Background: There is variation in the reported incidence of levator avulsion (LA). Objective: Explore incidence of LA by mode of birth, imaging modality, timing of diagnosis and laterality of avulsion. Search strategy: We searched MEDLINE, EMBASE, CINAHL, AMED and MIDIRS with no language restriction from inception to April 2019. Study eligibility criteria: A study was included if LA was assessed by an imaging modality after the first vaginal birth or if only delivered by caesarean section. Case series and reports were not included. Data collection and analysis: RevMan v5.3 was used for the meta-analyses and SW SAS and STATISTICA packages for type and timing of imaging analyses. . Results: We included 37 primary non-randomized studies from 17 countries and involving 5594 women. Incidence of LA was 1%, 15%, 21%, 38.5% and 52% following caesarean, spontaneous, vacuum, spatula and forceps births respectively, with no differences by imaging modality. OR of LA following spontaneous birth vs. caesarean was 10.69. While the OR for LA following vacuum and forceps compared to the spontaneous birth were 1.66 and 6.32 respectively. LA was more likely to occur on the right side following spontaneous birth (p = 0.02) and unilaterally vs. bilaterally following spontaneous (P < .0001) and vacuum-assisted births (P = 0.0103) only. Incidence was higher if assessment was performed in the first 4 weeks postpartum. Conclusions: Forceps significantly increases incidence and severity of LA. Ultrasound and MRI are comparable diagnostic tools but early postpartum imaging may lead to over diagnosis of LA.

Objectives: Assess first trimester serum placental growth factor (PLGF), soluble fms-like tyrosine kinase-1 (sFLT-1), interleukin-6 (IL-6), tumour necrosis factor-α (TNF-α), endothelin and vascular cell adhesion molecule (VCAM) in women with chronic hypertension (CH) stratified according to blood pressure (BP) control. Design: Case-control. Setting: Tertiary referral centre. Population: 650 women with CH, 142 normotensive controls. Methods: In the first trimester, patients with CH were subdivided into 4 groups. Group 1 included women without pre-pregnancy CH presenting with BP ≥140/90mmHg. Groups 2-4 had pre-pregnancy CH; in group 2 the BP was <140/90mmHg without antihypertensive medication, in group 3 the BP was <140/90mmHg with antihypertensive medication and in group 4 the BP was ≥ 140/90 mmHg despite antihypertensive medication. PLGF, sFLT-1, IL-6, TNF-α, endothelin and VCAM were measured at 11+0-13+6 weeks’ and converted into multiples of the expected median (MoM) using multivariate regression analysis in the controls. Main outcome measure: Comparisons of MoM values of PLGF, sFLT-1, IL-6, TNF-α, endothelin and VCAM between the 4 CH groups and the controls were made using analysis of variance or Kruskal-Wallis tests. Results: In the CH groups, compared to controls, PLGF was reduced in groups 2-4, sFLT-1 was reduced in groups 2 and 3, endothelin was increased in groups 1 and 4 but IL-6 was reduced in group 4. Conclusion: In women with CH, differences exist in first trimester angiogenic and inflammatory profiles according to BP control. Further evaluation is needed to determine if these differences are useful in the stratification of care.