Clinical outcome reporting in randomised controlled trials of remote obstetric antenatal monitoring: a systematic review (2026)

Type of publication:

Systematic review

Author(s):

Le Vance, Jack; Man, Rebecca; Adeoye, *Adekunle; Amaranathan, Sneha; Massey, Sian; Gurney, Leo; Morris, R Katie; Morton, Victoria Hodgetts

Citation:

European Journal of Obstetrics, Gynecology, & Reproductive Biology. 322:115122, 2026 Jun.

Abstract:

BACKGROUND: Over the last decade, remote technological initiatives for obstetric antenatal care have rapidly developed. However, variation in outcome reporting can preclude effective data synthesis. A remedy for this is to develop of a core outcome set (COS). However, prior to this, it is necessary to examine the heterogeneity of outcome reporting.

METHODS: MEDLINE, Embase, Cochrane Database of Clinical Trials (CENTRAL), Web of Science, and PubMed databases from January 2015 to November 2025. Randomised controlled trials (RCTs), RCT protocols or pilot RCTs which assessed any outcome for any type of remote monitoring device during the obstetric antenatal period were included. Study characteristics, outcomes definitions and timings were extracted and descriptively analysed.

RESULTS: Of the 4904 papers screen, 40 studies were included (24 full RCTs, 10 protocols and six pilot RCTs) The most common remote monitoring devices used, either in isolation or in combination, were blood pressure (n = 17, 42.5%) and blood glucose (n = 16, 40.0%). In total, 1004 verbatim outcomes were noted, categorised into 361 unique outcomes, across 72 domains. Outcome definition was heterogenous, with glycaemic monitoring demonstrating the largest variation, with 29 different definitions. Longer-term outcomes were infrequently reported, with fewer than 6% of all outcomes evaluating more than 3 months postpartum. Maternal remote monitoring devices were most commonly assessed, with 29 studies solely evaluating these devices. No single outcome was reported in all studies.

CONCLUSION: This review demonstrates a lack of consistent outcome reporting for trials examining remote antenatal monitoring devices. Consequently, the development of a COS is recommended.

DOI: 10.1016/j.ejogrb.2026.115122

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A Multicomponent Intervention to Improve Maternal Infection Outcomes (2026)

Type of publication:

Journal article

Author(s):

Lissauer, David; Gadama, Luis; Waitt, Catriona; Whyte, Sonia; Burnside, Girvan; Anilkumar, Aiswarya; Makuluni, Regina; Okwaro, Peace; Yang, Liu; Waitt, Peter; Musopole, Owen; Bilesi, Rosemary; Maseko, Bertha; Lwasa, Joel; Mugahi, Richard; Olaro, Charles; Lamorde, Mohammed; Makuta, Mirriam; Kachiwaya, Chimwemwe; Mkandawire, Tionge; Malunga, Adrian; Chitsulo, Nyadani; Abitimo, Prisca; Ayabo, Tabitha; Weeks, Andrew; Martin, James; Hemming, Karla; Gallos, Ioannis; Monk, Edward J M; Riches, Jennifer; Chapuma, Chikondi; Nanyondo S, Judith; Lorencatto, Fabiana; Monahan, Mark; Allegranzi, Benedetta; Dunlop, Catherine; Atkins, Lou; Rosala-Hallas, Anna; Roberts, Tracy; Gamble, Carrol; Malata, Address; Desmond, Nicola; Kommwa, Edward; Merriel, Abi; *Parry-Smith, William; Smith, Rebecca; Ndumu, Ivy; Williams, Eleanor; Faque, Bob; Banda, Gertrude; Nyondo-Mipando, Alinane L; Twimukye, Adelline; Chater, Tim; Diplas, Aristotelis; Brizuela, Vanessa; Souza, Joao Paulo; Rylance, Jamie; Cheshire, James; Hawker, Lydia; Coomarasamy, Arri; Bonet, Mercedes.

Citation:

New England Journal of Medicine. 394(17):1685-1695, 2026 Apr 30.

Abstract:

BACKGROUND: Maternal infection and sepsis are major causes of maternal death and severe illness worldwide, particularly in low- and middle-income countries. Inconsistent implementation of evidence-based recommendations for infection prevention and management and delays in detection and treatment of maternal sepsis contribute to the number of preventable deaths.

METHODS: We conducted a cluster-randomized trial to assess a multicomponent intervention, the Active Prevention and Treatment of Maternal Sepsis (APT-Sepsis) program. This program was designed to support health care providers in achieving three goals: adherence to World Health Organization (WHO) hand-hygiene standards; adoption of evidence-based practices for maternal infection prevention and management; and early detection of sepsis and use of the FAST-M (fluids, antibiotics, source control, transfer if required, and monitoring) treatment bundle. Usual care was provided in the control group, along with dissemination of guidelines. The primary outcome was a composite of infection-related maternal death, infection-related near-miss event (events in which women survived a life-threatening complication), or severe infection-related illness (deep surgical-site, deep perineal, or body-cavity infection) among women who were pregnant or had recently been pregnant.

RESULTS: We randomly assigned 59 health facilities (where 431,394 women gave birth during the trial) in Malawi and Uganda to the intervention group (30 clusters) or the usual-care group (29 clusters). A primary-outcome event occurred in 1.4% of the patients in the intervention group and in 1.9% of those in the usual-care group (risk ratio, 0.68; 95% confidence interval, 0.55 to 0.83; P<0.001). This effect was generally consistent between countries and among facilities of difference sizes and was sustained over time.

CONCLUSIONS: Implementation of the APT-Sepsis program led to a significantly lower risk of a composite of infection-related maternal death, infection-related near-miss event, or severe infection-related illness than usual care. (Funded by the Joint Global Health Trials scheme and others; APT-Sepsis ISRCTN number, ISRCTN42347014.).

DOI: 10.1056/NEJMoa2512698

Is digital documentation always best? (2026)

Type of publication:

Journal article

Author(s):

Rai, Tanvi; *Millward, Helen; *Siddall, Kate; Riddell, Nathan S; *Elsmore, Amy; Dhadda, Amrit; *Willson, Seren; Collis, Rachel; *Parry-Smith, William; Collins, Peter; Hinton, Lisa; Bell, Sarah.

Citation:

International Journal of Gynaecology & Obstetrics. 2026 May 16.

DOI: 10.1002/ijgo.71079

Routine pre-operative CT imaging in Grade 2 endometrial cancer: A two-year retrospective review of clinical impact (2026)

Type of publication:

Conference abstract

Author(s):

*Alayande G.

Citation:

BJOG: An International Journal of Obstetrics and Gynaecology. Conference: BGCS 2026 Book of Abstracts. Bristol United Kingdom. 133(Supplement 2) (pp S14), 2026. Date of Publication: 01 Jun 2026.

Abstract:

Background: The British Gynaecological Cancer Society (BGCS) guidance does not recommend routine pre-operative CT imaging in low-grade endometrial cancer due to its low diagnostic yield and limited impact on outcomes. At Shrewsbury and Telford Hospital NHS Trust, however, all patients with confirmed Grade 2 (or higher) endometrial cancer undergo preoperative CT-TAP in line with local guidance. Objective(s): To assess adherence to local guidance and determine whether pre-operative CT influences gynaecological management. A secondary aim was to evaluate the frequency and consequences of incidental findings. Method(s): We retrospectively reviewed patients diagnosed with Grade 2 endometrial cancer between April 2023 and May 2025 using the Somerset Cancer Register. Patients diagnosed postoperatively were excluded. Electronic records were examined to assess whether CT findings altered management, defined as referral to a tertiary centre. Result(s): Of 52 identified patients, 46 met inclusion criteria. All underwent pre-operative CT imaging. Findings suggestive of metastatic disease were reported in 13% (6/46), prompting tertiary referral in four surgically fit patients; one was later found to have stage IA disease, representing potential overtreatment. Incidental findings occurred in 45% (21/46), with 38% (8/21) requiring further investigation. Most were clinically insignificant, though one led to a new breast cancer diagnosis. Conclusion(s): In this cohort, routine pre-operative CT imaging in Grade 2 endometrial cancer influenced management in a clinically meaningful way. Nevertheless, potential overtreatment and the implications of incidental findings should inform imaging decisions.

DOI: 10.1111/1471-0528.70281

Audit of compliance with trust PMB protocol V6 in the management of postmenopausal bleeding in women not on HRT (2026)

Type of publication:

Conference abstract

Author(s):

*Huda N.-U.; *Sahu B.

Citation:

BJOG: An International Journal of Obstetrics and Gynaecology. Conference: BGCS 2026 Book of Abstracts. Bristol United Kingdom. 133(Supplement 2) (pp S40), 2026. Date of Publication: 01 Jun 2026.

Abstract:

Background: Postmenopausal bleeding (PMB) occurs in 5-10% of women who are not on hormone replacement therapy (HRT). Around 90% of women diagnosed with endometrial cancer present with vaginal bleeding. National guidance and local Trust protocol PMB V6 recommend urgent referral and timely investigation to exclude malignancy. Early and effective triage is essential to meet the Faster Diagnosis Standard. Objective(s): To assess compliance with Trust PMB protocol V6 (November 2024) for the management of postmenopausal bleeding in women not on HRT, and to evaluate whether diagnosis was established within 28 days in line with the Faster Diagnosis Standard. Method(s): A retrospective audit was conducted of women not on HRT referred with PMB. Compliance was assessed against Trust standards, including triage, transvaginal ultrasound (TVS), endometrial thickness (ET) measurement, and appropriate use of hysteroscopy and biopsy. Outcomes were compared with protocol targets. Result(s): There was excellent compliance with diagnostic management in secondary care. Most women underwent timely TVS with accurate ET measurement, and those with ET >= 8 mm or additional risk factors appropriately proceeded to hysteroscopy. Women with thin endometrium were safely discharged without intervention. However, delays were identified in achieving diagnosis within 28 days. These were mainly due to delays in triage, investigations, review of results, and communication with patients. Conclusion(s): While diagnostic management of PMB showed strong compliance with Trust protocol, gaps were identified in meeting the Faster Diagnosis Standard. Separating HRT and non-HRT pathways, improving triage, and strengthening communication are essential to optimise resource use, improve patient experience, and ensure timely cancer exclusion.

DOI: 10.1111/1471-0528.70281

Placental site trophoblastic tumour beyond the reproductive years: A rare cause of postmenopausal bleeding (2026)

Type of publication:

Conference abstract

Author(s):

*Kabra S.; *Alayande G.; *Malik N.

Citation:

BJOG: An International Journal of Obstetrics and Gynaecology. Conference: BGCS 2026 Book of Abstracts. Bristol United Kingdom. 133(Supplement 2) (pp S44-S45), 2026. Date of Publication: 01 Jun 2026.

Abstract:

Background: Placental site trophoblastic tumour (PSTT) is a rare subtype of gestational trophoblastic neoplasia arising from intermediate trophoblastic cells at the placental implantation site. It typically occurs in women of reproductive age following a prior pregnancy, although rare cases have been reported in perimenopausal and menopausal women. A UK population-based study reported only 75 cases over a 21-year period. Objective(s): To report a rare presentation of PSTT in a menopausal woman. Method(s): Case report and literature review. Result(s): A 46-year-old woman presented with heavy vaginal bleeding after two years of amenorrhoea. Her last pregnancy was a term caesarean section three years previously. Transvaginal ultrasound showed a postmenopausal endometrial thickness of 6 mm, and she was referred through the urgent suspected cancer pathway. Diagnostic hysteroscopy was attempted but abandoned due to poor visualisation from active bleeding. Pipelle endometrial biopsy revealed an infiltrative lesion composed of intermediate trophoblastic cells with immunohistochemistry positive for AE1/AE3 and human placental lactogen (hPL), consistent with PSTT. MRI pelvis demonstrated a 3 cm lesion involving the anterior myometrium extending into the endometrial cavity. Staging CT of the chest, abdomen and pelvis showed no distant metastasis. Following multidisciplinary discussion with the regional gestational trophoblastic disease centre, hysterectomy was recommended as definitive treatment. Conclusion(s): PSTT is a rare but important differential diagnosis for postmenopausal bleeding. Early histopathological diagnosis, appropriate imaging and multidisciplinary management are essential for optimal outcomes.

DOI: 10.1111/1471-0528.70281

Beyond virilisation: Two non-functional ovarian steroid cell tumours and a critical review of the literature (2026)

Type of publication:

Conference abstract

Author(s):

*Huda N.-U.; *Chai A.C.; *Sahu B.

Citation:

BJOG: An International Journal of Obstetrics and Gynaecology. Conference: BGCS 2026 Book of Abstracts. Bristol United Kingdom. 133(Supplement 2) (pp S40-S41), 2026. Date of Publication: 01 Jun 2026.

Abstract:

Background: Ovarian steroid cell tumours (SCTs) are rare sex cord-stromal neoplasms (<0.1% of ovarian tumours). Most secrete androgens causing virilisation, but up to 40% are nonfunctional and discovered incidentally. Their variable presentation and overlapping histology make diagnosis challenging. Objective(s): To describe two cases of non-virilising ovarian SCTs managed at our institution, review their management, and contextualise findings within the current literature. Method(s): We report two patients diagnosed with nonfunctional ovarian SCTs. Case 1: a 77-year-old woman with an incidental left ovarian mass; Case 2: a 56-year-old woman presenting with postmenopausal bleeding and right ovarian mass. Both underwent surgical excision. Histopathology and immunohistochemistry (inhibin, calretinin, Melan-A) confirmed diagnosis. Patients were followed with imaging, tumour markers, and hormonal assays. A literature review of major series and molecular insights was conducted.
Result(s): Case 1 had a large (16 x 10 cm) left-sided tumour, FIGO stage IA, with no malignant features. Case 2 had a smaller (5.5 x 4 cm) right-sided tumour, FIGO stage IC2, with capsular invasion. Both patients had uneventful recoveries and remain recurrence-free on long-term surveillance. Literature review highlights the heterogeneity of SCTs, with non-functional tumours comprising ~40% of cases, generally presenting at early stages, and showing favourable outcomes with surgery alone. Histologic predictors of malignancy include tumour size >= 7 cm, mitotic activity, necrosis, and atypia. Molecular data suggest potential links with VHL, FH, and APC mutations, but prognostic markers remain limited. Conclusion(s): Non-functional ovarian SCTs may present incidentally and are often cured with surgery. Accurate diagnosis relies on histology and immunohistochemistry, and lifelong follow-up is recommended due to unpredictable malignant potential.

DOI: 10.1111/1471-0528.70281

Audit on the recognition and initial management of ovarian cancer in secondary care: Compliance with NICE CG122 & QS18 (2026)

Type of publication:

Conference abstract

Author(s):

*Huda N.-U.; *Sahu B.

Citation:

BJOG: An International Journal of Obstetrics and Gynaecology. Conference: BGCS 2026 Book of Abstracts. Bristol United Kingdom. 133(Supplement 2) (pp S41), 2026. Date of Publication: 01 Jun 2026.

Abstract:

Background: Ovarian cancer is the sixth most common cancer in women in the UK and is often diagnosed at an advanced stage due to non-specific early symptoms. NICE Clinical Guideline CG122 and Quality Standard QS18 provide recommendations for timely recognition, investigation, and referral. Objective(s): To evaluate whether women presenting with symptoms suggestive of ovarian cancer were investigated and managed in accordance with NICE CG122 and QS18 in our NHS Trust. Method(s): A retrospective audit was conducted on 20 women referred to the gynaecology department with suspected ovarian malignancy. Data collected included age, tumour markers (CA125), risk of malignancy index (RMI), imaging, tissue diagnosis, chemotherapy decisions, tertiary care involvement, and access to support services. Result(s): Most patients (95%) were over 40 years old. Advanced-stage disease was present in 65% of cases. Compliance with tumour marker testing and imaging was generally high, but RMI calculation and referral documentation were inconsistent. Ninety percent of advanced-stage patients had tissue diagnosis prior to chemotherapy. Definitive surgery was mainly performed in tertiary centres. Support needs were not routinely identified, and trial participation was limited. Delays in investigations and referral were noted in a minority of cases, and atypical presentations posed diagnostic challenges. Documentation regarding lymph node assessment during staging was incomplete. Recommendations: Enhance patient flagging to support services, provide targeted clinician education on NICE guidelines, and share audit feedback with tertiary partners. Conclusion(s): While most patients received appropriate investigations and referral, improvements are needed in early recognition, documentation, and holistic care planning. Ongoing audit and education are essential to optimise adherence to guidelines and improve outcomes in ovarian cancer management.

DOI: 10.1111/1471-0528.70281

Management of post-menopausal women who are high-risk HPV positive with normal, borderline, or mildly dyskaryotic cytology and unsatisfactory colposcopy (2026)

Type of publication:

Conference abstract

Author(s):

Stout A.; *Sutherland D.; China S.; Byrom J.

Citation:

BJOG: An International Journal of Obstetrics and Gynaecology. Conference: BGCS 2026 Book of Abstracts. Bristol United Kingdom. 133(Supplement 2) (pp S80-S81), 2026. Date of Publication: 01 Jun 2026.

Abstract:

Background: Unsatisfactory colposcopy is common, occurring in 10-20% of women. Post-menopausal women who are high-risk HPV positive with normal, borderline, or mildly dyskaryotic cytology and unsatisfactory colposcopy represent an increasing management dilemma. Currently, there is no guideline for this group. Management among UK colposcopists is thought to vary. Objective(s): Our survey aimed to collate opinions of BSCCP members regarding management of this patient group, and identify a consensus opinion. We sought to compare trends with a similar survey conducted in 2018, following the introduction of primary HPV screening. Method(s): All BSCCP members were invited to complete an online survey conducted between 29/01/2026 and 05/03/2026. Result(s): We received 141 responses from medical and nursing colposcopists, the majority being experienced practitioners. Management strategies varied considerably. 60.7% would perform see-and-treat LLETZ in all or high-risk patients, while 17.9% would never offer treatment at first review. If histology was not obtained initially, 52.9% recommended repeat cytology and colposcopy at 12 months. For persistent disease >24 months, 52.2% recommended LLETZ, with an additional 45.6% considering treatment based on patient preference or risk factors. Hysterectomy was offered by 84.9% in persistent cases with risk factors or on request. Compared with 2018, see-and-treat LLETZ was more common, follow-up intervals were longer, and MDT discussion less frequent. Conclusion(s): Practice among UK colposcopists in this patient group remains variable, and demand for national guidance is high. Our survey demonstrated variety in practise on initial presentation, with a preference for excisional treatment or hysterectomy in cases of persistent disease.

DOI: 10.1111/1471-0528.70281

Variation in antenatal anaemia guidelines across the NHS in the United Kingdom: A cross-sectional study (2026)

Type of publication:

Journal article

Author(s):

Haynes S.; Balboula I.; Collins P.; *Parry-Smith W.; Fye H.; *Elsmore A.; Collis R.; De Lloyd L.; Churchill D.; Bell S.F.; Stanworth S.J.

Citation:

British Journal of Haematology. (no pagination), 2026. Date of Publication: 2026. [epub ahead of print]

Abstract:

Antenatal anaemia affects up to 30% of pregnant women in the United Kingdom and is a recognised clinical priority. National management guidance is published by the British Society of Haematology (BSH), but the extent to which local National Health Service (NHS) guidelines align with it is unknown. We conducted a cross-sectional document analysis of antenatal anaemia guidelines from 49 NHS sites across the United Kingdom, obtained through two national research programmes. Two reviewers independently extracted data on screening, diagnosis, treatment and monitoring, using the 2020 BSH guideline as the national reference standard. The included guidelines represented approximately 33% of annual UK births. Screening and diagnostic haemoglobin thresholds were broadly consistent with BSH guidance, whereas substantial variation was concentrated in treatment and monitoring: oral iron indications, dosing and duration; haemoglobin thresholds and clinical criteria for intravenous iron; and the timing, biomarkers and response definitions used after treatment. Ferritin thresholds, reassessment intervals and response criteria were frequently absent or divergent. Variation was greatest in domains where the underlying evidence base is least resolved. These findings characterise the nature and extent of guideline-level variation across NHS maternity care and identify priority areas for future research and national guideline development.

DOI: 10.1111/bjh.70780

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