Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.

This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.

The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.

28 October 2024, V.8.0.

jRCT1091220353.

Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

Measuring foetal heart rate (FHR) is critical for assessing foetal well-being, and traditional cardiotocography (CTG), though effective, has limitations such as cost, accessibility and observer bias. Newer non-invasive foetal ECG (NIFECG) devices offer more precise, reliable metrics for FHR variability and could enable remote monitoring, potentially improving early detection of foetal complications like hypoxia and stillbirth.

This is a single-centre prospective cohort study taking place in a tertiary maternity unit in the UK. Women with a singleton pregnancy over 26⁺⁰ weeks will be approached for participation in the control, foetal growth restriction (FGR) or diabetic groups. The NIFECG home monitoring schedule is 60 min daily for 7 days in the control group, daily from diagnosis until delivery for the FGR group, and daily from 36 weeks until delivery in the Insulin-dependent diabetic group. Longitudinal FHR raw ECG signals will be collected from participants across different gestational age ranges. Reference standards for FHR variability using metrics such as short-term variation, phase-rectified signal averaging acceleration and deceleration capacity will be established. The study will also aim to explore differences in FHR variability in FGR cases against controls and propose safety thresholds to guide decision-making for delivery.

Approvals have been obtained from the London Stanmore Research Ethics Committee and from the Medicines and Healthcare Regulatory Agency. The results will be published in peer-reviewed journals, presented at conferences and used by the commercial sponsor to pursue European Conformity regulatory compliance marking and future clinical studies.

NCT06497205.

Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.

The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth

The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.

NCT06122506.

To explore how urinary (UI) and anal incontinence (AI) affect various aspects of quality of life (QoL) and the risk of depression 6 months postpartum, using patient-reported outcome measures (PROMs).

Prospective cohort study.

Women who gave birth between 2020 and 2022 within a local obstetric collaborative network in the Netherlands, including 13 midwifery practices, 5 maternity care organisations at the primary care level, and 1 secondary teaching hospital.

Prospectively collecting data by using the questionnaires of the International Consortium for Health Outcome Measures Pregnancy and Childbirth set at five moments during pregnancy and postpartum.

Associations between UI, AI, QoL and likelihood of depression based on PROMs collected from questionnaire 6 months postpartum.

Of the 663 women who completed the 6-month postpartum questionnaire, 79 women had severe UI, 71 had severe AI and 45 experienced both. These women reported significantly lower QoL as measured by PROMIS-10: 34 (IQR 30.5–38.5), 34 (IQR 30–39.5), and 32 (IQR 27–35), respectively, compared with a score of 37 (IQR 33–42) for the total population. Additionally, the positive rate for depression screening was notably higher among these groups, with rates of 6%, 10% and 18%, respectively, compared with 3% for the overall group.

In this observational cohort study, we found that severe UI and/or AI 6 months postpartum significantly impact QoL and increase the likelihood of depression, as indicated by PROMs. Our findings emphasise the importance of screening, evaluation and treatment of UI and/or AI to improve the QoL and reduce the risk of depressive disorders for postpartum women.

Chronic endometritis (CE) is regarded as a potential factor contributing to infertility and embryo implantation failure. The cause of CE remains unclear at present, but it might be associated with intrauterine microbial infections. Empirical antibiotic treatment typically consists of a 2-week course of oral levofloxacin combined with oral metronidazole. Currently, there is no research comparing the efficacy of oral levofloxacin versus vaginal metronidazole suppositories in improving pregnancy outcomes for these patients. This study aims to evaluate the effectiveness of combining oral levofloxacin with metronidazole suppositories in the treatment of CE. The goal is to enhance clinical pregnancy rates and live birth rates among patients undergoing in vitro fertilisation (IVF), while concurrently mitigating the incidence of miscarriages.

The trial concerning the combination of levofloxacin and metronidazole suppositories for the treatment of CE is a single-centre, randomised controlled clinical trial. We plan to recruit female patients with CE who are planning to undergo IVF. Following informed consent, eligible participants will be randomly assigned in a 1:1 ratio to receive either daily oral levofloxacin combined with oral metronidazole or oral levofloxacin combined with a metronidazole suppository for 2 weeks until the human chorionic gonadotropin trigger day. All IVF procedures will be carried out routinely at this centre. The primary outcome is the live birth rate after embryo transfer, while the secondary pregnancy outcomes include clinical pregnancy rates and miscarriage rates.

This study has been approved by the Ethics Committee of Peking University Third Hospital on 28 June 2024 (Reference No. IRB00006761-M2023857). Written informed consent will be acquired from all participants prior to randomisation. The study findings will be submitted to scientific conferences and peer-reviewed journals.

NCT06650540.

Pelvic organ prolapse (POP) is the descent of one or more pelvic organs through the vaginal canal, including the vagina, uterus, rectum, bladder, cervix, posthysterectomy vaginal cuff, and small or large bowel, which compromises a woman’s physical, mental and social well-being.

This study aimed to explore how women with POP experience their living and its impact on their quality of life (QoL).

This was a qualitative study using interpretive phenomenological analysis, following in-depth structured interviews. Analysis was undertaken to identify superordinate themes relating to how women are living with POP.

3 public hospitals and 3 woredas in Gurage zone, Central Regional State, Ethiopia.

A purposive sample of 12 women who were diagnosed with POP was recruited.

Five core themes with subthemes were identified; general health judgement, POP symptom, life situation related to POP, feeling about POP and limitation in daily life/activity. The majority of respondents expressed concern that the prolapse had negatively impacted their general health and voiced hope that pelvic floor reconstruction would improve their general well-being. The majority of the informants stated that disclosing to others might significantly lower their QoL and that having the condition was extremely embarrassing. The women were most affected by the actual physical symptoms of prolapse (bulge, back pain, heaviness, bowel problems, urinary incontinence) as well as by the impact prolapse has on their sexual function.

Women with POP should be offered psychosocial support, early care and counselling because they have physical, personal, emotional, social and sleep/energy problems. Healthcare providers should take the initiative in educating women regarding prolapse and to make them aware that it is a treatable condition which can improve their QoL.

Overexpression of p16 has been documented in a variety of human tumours. Nonetheless, the association between p16 overexpression and the clinicopathological characteristics of patients with cervical cancer remains a subject of debate. This meta-analysis sought to systematically assess the relationship between p16 expression and the clinicopathological features of patients with cervical cancer.

Systematic review and meta-analysis.

The PubMed, Embase, Cochrane Library (Central), Web of Science (SCI Expanded), and Chinese databases (CNKI, VIP, Wanfang and CBM) were searched through 1 March 2024.

Case-control studies examining the association between p16 expression and cervical cancer were analysed to evaluate whether p16 expression was correlated with the clinicopathological characteristics of patients with cervical cancer.

Two independent reviewers employed standardised methods to search, screen and code the included studies. The risk of bias was evaluated using the Cochrane Collaboration tools and the Newcastle-Ottawa Scale. Statistical analyses and data processing were conducted using Review Manager V.5.4, which included heterogeneity tests and sensitivity analyses. Additionally, STATA V.16.0 was used for further sensitivity analyses of the included studies, and publication bias was assessed using Begg’s test.

The p16 protein is strongly associated with the onset and progression of cervical cancer and serves as a valuable biomarker for its early detection and diagnosis.

CRD42024546241.

This study assessed the knowledge, attitude and practice (KAP) of pregnant women in Chongqing, China, regarding pre-eclampsia and examined their inter-relationships.

A cross-sectional survey was conducted using validated questionnaires.

The study was conducted between May 2023 and August 2023 in Chongqing, China.

A total of 427 pregnant women were included, with 68.15% aged ≤30 years and a mean pregnancy duration of 238.18±45.01 days.

This was an observational study, and interventions were applied.

The primary outcomes were the KAP scores (knowledge: 0–40; attitude: 12–60 and practice: 10–50). The correlations and structural equation modelling (SEM) analyses were conducted to explore the relationships among KAP.

Mean scores were 22.19±12.17 (knowledge), 46.38±6.14 (attitude) and 41.96±5.96 (practice). Knowledge positively correlated with attitude (r=0.586, p

Pregnant women exhibited inadequate knowledge and a suboptimal attitude but a proactive practice. Targeted interventions to improve knowledge and attitudes are recommended for better clinical outcomes, particularly in regions where few such studies have been conducted.

Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.

This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD.

We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks’ gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5–20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary).

All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations.

NCT05186272.

Antenatal care (ANC) is a critical component for improving maternal and newborn health. It provides a platform for essential healthcare services, including health promotion, screening and diagnosis, injury and disease prevention, birth preparedness and preparation for the postnatal period. By implementing timely and appropriate evidence-based practices, ANC can reduce maternal and child morbidity and mortality and optimise overall health and well-being.

To assess the magnitude of utilisation of ANC with eight or more contacts and its associated factors among pregnant women attending ANC in Yayo District, 2023.

A facility-based cross-sectional study was conducted among 301 randomly selected pregnant women attending ANC follow-up in selected health facilities in Yayo District, Southwest Ethiopia, from 1 June 2023 to 30 June 2023. Data were collected using an interviewer-administered structured questionnaire. The collected data were coded and entered into Epi Data V.4.6 and then exported to SPSS V.26 for descriptive and inferential analysis. Both bivariate and multivariate logistic regression models were fitted. Adjusted OR (AOR) with a 95% CI was estimated to assess the strength of associations. A p value

A total of 298 pregnant women participated in the study, yielding a response rate of 99%. Most of the pregnant women, 139 (46.6%), were housewives, and the majority, 248 (83.2%), were married. Adequate utilisation of ANC with eight or more contacts was found to be 7.7%. Factors significantly associated with ANC 8+ contacts utilisation include previous pregnancy-related complications (AOR 5.238 (95% CI 1.004 to 27.31)) and early initiation of ANC (AOR 29.09 (95% CI 8.87 to 95.3)).

The magnitude of ANC 8+ contacts utilisation was remarkably low in the study area. Therefore, greater investment is needed to promote the new ANC approach, emphasising ANC 8+ contacts. Special attention should be given to mobilising mothers to initiate ANC before 12 weeks of gestation to reduce the risk of complications and ensure maximum utilisation of ANC 8+ contacts.

Tubal ectopic pregnancy (TEP) frequently presents as a gynaecological emergency, often necessitating prompt medical intervention. Although methotrexate therapy offers the advantage of being non-invasive, it still poses the risk of tubal rupture and consequent haemorrhage, which may require emergency surgery. The major challenges encountered in practice are the lack of reliable methods to anticipate the likelihood of failure of single-dose methotrexate therapy and identify associated risk factors and thereby preclude unnecessary medical procedures. Effective counselling, therefore, remains a pivotal step in clinical management. This study is aimed at developing a predictive model to assess response to single-dose methotrexate therapy in cases of TEP by employing a dynamic prediction model approach based on the clinical data of a large cohort.

This multicentre study will encompass 100 and 900 participants for the prospective and retrospective cohorts with TEP, respectively. Between 2010 and 2024, eligible patients who are diagnosed with TEP and opt for single-dose methotrexate therapy will be recruited as part of a retrospective cohort, from three participating hospitals in Zhejiang province, China. The comprehensive medical and obstetric histories of the patients will be collected, along with their clinical data, including the results of serological tests following the initial consultation. The control group will comprise patients who achieve uneventful, complete resolution of TEP, as evidenced by serum human chorionic gonadotropin level of

Ethical approval for data collection has been obtained from the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (No. 2024-KLS-346–02), Hangzhou First People’s Hospital (No. ZN-20240627-0219-01), Anji Hospital of Chinese Medicine (No. 2025年第5号), Qingyuan Hospital of Chinese Medicine (No. (2024)伦审第(9)号) and Beilun Hospital of Chinese Medicine (No. 2024年伦审第12号). Additionally, written informed consent will be obtained from all participants and they will retain the right to withdraw from the study at any stage. The findings of this study will be disseminated through publication in a peer-reviewed journal.

ChiCTR2400085829.

The postnatal period is critical for preventing maternal and neonatal morbidity and mortality. Globally, a significant proportion of maternal and neonatal deaths occur within the first 6 weeks after delivery. Timely and adequate postnatal care (PNC) can detect and manage life-threatening complications; however, service utilisation remains alarmingly low in many low- and middle-income countries, including Saudi Arabia. Addressing the behavioural and perceptual factors that influence service use is essential for improving health outcomes.

This study aimed to assess mothers’ utilisation of PNC services and examine how their health beliefs and sociodemographic characteristics influence this behaviour.

A cross-sectional study guided by the Health Belief Model (HBM) was conducted to explore predictors of PNC utilisation.

Eight primary healthcare (PHC) centres were randomly selected from 179 PHC centres distributed in the different governorates of the Jazan region of Saudi Arabia.

A total of 464 mothers were surveyed between October and December 2023 using an interviewer-administered questionnaire.

The primary outcome was PNC utilisation, defined by the number of postnatal visits. The independent variables included sociodemographic characteristics and HBM constructs (perceived susceptibility, benefits, barriers and cues to action).

In terms of PNC utilisation, 80.0% of participants had two or fewer postnatal visits, whereas 20.0% had three or more postnatal visits. Perceived barriers had the strongest influence (mean score 2.51±0.87), followed by cues to action (2.43±0.89), susceptibility (1.92±0.72) and benefits (1.86±0.64). In the multivariate analysis, perceived barriers, cues to action and perceived susceptibility were significantly associated with PNC utilisation, with adjusted ORs of 1.679 (95% CI: 1.007 to 2.799), 0.470 (95% CI: 0.256 to 0.863) and 0.405 (95% CI: 0.197 to 0.832), respectively.

PNC utilisation in the Jazan region remains suboptimal. Perceptual factors, particularly barriers and cues to action, play a central role in service use. Health interventions targeting these beliefs and improving follow-up mechanisms may help increase PNC engagement and improve maternal and infant health outcomes in Saudi Arabia.

Sweden, as many other high-income countries, has adopted guidelines to offer induction of labour at 41+0 gestational weeks to decrease the risk for perinatal death. As more than 20% of the pregnant population reach this gestational age, and along with other contributing factors, induction rates have increased up to 30% in many countries. Both women and care providers have raised the question if outpatient induction could be a convenient, safe and economic alternative, reducing the burden on inpatient care in maternity hospitals. Before introducing outpatient induction into clinical routine, studies need to assure safety for the child and woman as well as efficacy of the method.

A register-based randomised controlled multicentre non-inferiority trial to study if outpatient induction in low-risk inductions is (1) as safe for the child (perinatal composite of mortality and morbidity) and (2) as effective (proportion of vaginal deliveries) as inpatient induction at the hospital. Secondary outcomes are further health outcomes, experiences of pregnant women, partners and care providers, health economics and future pregnancy outcome. Participating women with a singleton pregnancy and unripe cervix between 37+0 and 41+6 gestational weeks planned for low-risk induction will undergo induction of labour with either a balloon catheter or oral misoprostol according to clinical practice at the study site and the woman’s informed choice. Randomisation will allocate women to either outpatient (home or patient hotel) or inpatient induction (standard care). Women undergoing outpatient induction can remain at home for up to 2 days, with an assessment after 24 hours including cardiotocography. Once active labour ensues, all women will receive standard care in the hospital.

The assessment of non-inferiority will involve a two-sided 95% CI and 80% power, requiring randomisation of 8891 women to ensure a probability of at least 0.80 that the upper limit of a two-sided 95.7% CI for a difference in the primary safety outcome is below the non-inferiority margin of 1.5%. 31 of the 45 delivery units in Sweden are currently recruiting. Data will be collected from the electronic case report form and Swedish healthcare registers. Questionnaire and qualitative interview-based studies will be performed to explore experiences of pregnant women, partners and care providers. Additionally, a health economic evaluation will be performed.

The Swedish Ethical Review Authority approved the study (3 June 2020; 2020-02675 with amendments 2021-03045, 2022-00865-02, 2023-01252-02, 2024-00560-02, 2024-2024-04597-02). The Swedish Medical Products Agency approved the study for the medication arm (25 August 2020, EudraCT number: 2020-000233-41; 5.1-2020-60240 with amendments 5.1-2022-73500, 5.1-2023-630). Due to changed regulation, in 2023, the study medication arm was transferred and approved by the European Medicines Agency (23 October 2023, EU CT Number: 2023-507164-39-00; CTIS 5.1.2-2023-099775 with amendments 5.1.2-2024-081916, 5.1.2-2025-036291). The Swedish Medical Products Agency approved the study for the medical device arm (6 April 2021, CIV-ID: CIV-20-09-034712; 5.1-2021-14812 with amendments 5.1-2022-14252, 5.1-2023-596, 5.1-2024-8886, 5.1-2024-55554). The medical device arm was transferred to Regulation (EU) 2017/745 (23 December 2024, 5.1-2025-24242 and amendment 5.1-2025-6050). The study will involve more than 80% of all delivery units in Sweden, which will allow for a smooth implementation of any new routine after the study’s conclusion. Results will be published in relevant scientific journals, presented at national and international conferences, and communicated to participants and relevant institutions through the Outpatient Induction study homepage (www.optionstudien.se), the webinars of the Swedish Network for National Clinical Studies in Obstetrics and Gynecology (www.snaks.se) as well as social and public media.

EudraCT No: 2020-000233-41, after transfer to the European Medicines Agency EU CT Number: 2023-507164-39-00; CIV-ID 20-09-034712.

To examine the impact of the COVID-19 pandemic on the substitution of surgical procedures in benign gynaecology in the Netherlands.

Quantitative longitudinal study evaluating the effects of the COVID-19 pandemic.

Nationwide healthcare delivery was analysed across six benign gynaecological pathways from 2016 to 2022 using Vektis and Dutch Hospital Data (DHD), accessed via Statistics Netherlands (Centraal Bureau voor de Statistiek).

The study focused on six benign gynaecological pathways classified using Dutch Diagnosis Treatment Combinations (DTCs): heavy menstrual blood loss (G11), uterine fibroids (G15), endometriosis (G17), prolapse (G25), infertility treatment (F11) and first trimester pregnancy complications (Z12). All patients receiving care within these pathways between 1 January 2016 and 31 December 2022 were included. Exclusions applied to all patients under 18 years old and, only within the menstrual disorder pathway, patients over 51 years old to exclude most postmenopausal blood loss cases where no alternative treatment applies.

Cohorts from the initial pandemic year (2020) were compared with four prepandemic cohorts (2016–2019) and late-pandemic (2021) and postpandemic (2022) cohorts.

The primary outcome was the trend in the total number of patients in surgical and non-surgical procedure groups across cohort periods. Secondary outcomes included trends within individual pathways.

The analysis identified a significant reduction in benign gynaecological care during 2020, with an 18.3% (p

The COVID-19 pandemic significantly disrupted both surgical and non-surgical procedures within benign gynaecological pathways. Reduced care uptake during the pandemic waves was not recovered but instead forgone. The reduction in surgical procedures did not correspond with increased use of non-surgical alternatives. Future research should prioritise evaluating the long-term impacts of this disruption on patients and society.

To evaluate the feasibility and acceptability of integrating point-of-care ultrasound scan (POCUS) by midwives into routine antenatal care (ANC) services.

Prospective, observational, multiphase, implementation science study.

Primary outcomes included the proportion of midwives who completed training and competency checks for basic obstetric scanning using a POCUS device; the feasibility and acceptability of midwife-delivered POCUS from the perspectives of midwives and pregnant women captured on structured questionnaires; and the proportion of scans meeting predefined quality standards. Secondary outcomes included responses to acceptability-related questionnaires administered to midwives and pregnant women.

Rural, periurban and urban health centres in Blantyre District, Malawi.

Pregnant women attending ANC and midwives providing care at participating health facilities.

Obstetric registrars trained and mentored 45 midwives, and 42 (93%) completed the training. Most midwives (95%, n=40) found providing POCUS during ANC was feasible and acceptable. Overall, device durability was rated positively. Of the 1499 pregnant women who received a scan, 99% (n=1484) reported that receiving an ultrasound from a midwife during ANC was acceptable. Independent assessors determined that over 70% of the subsample of reviewed scans met minimum quality standards.

Midwife-delivered POCUS is feasible and highly acceptable in diverse antenatal settings in Malawi. These findings support task-sharing models as a means of expanding access to this essential ANC service, particularly in low-resource settings.

Pre-eclampsia and fetal growth restriction (FGR) are two principal complications of pregnancy related to placental dysfunction. Nevertheless, knowledge of the underlying pathophysiological mechanisms remains inadequate, and only a few tools are available for in vivo assessment of placental perfusion. Contrast-enhanced ultrasound (CEUS) allows organ vascularisation evaluation via a strictly intravascular gas microbubble. The primary aim of this study is to compare placental vascularisation parameters obtained via CEUS between pregnancies with FGR and those without FGR.

This is a single-centre, prospective, comparative, non-randomised, feasible, open and interventional study. We will include 30 women with medical termination of pregnancy divided into two groups: one with severe FGR and the other without FGR. Severe FGR is defined as an estimated fetal weight below the third percentile for gestational age. Women will be informed and recruited in the fetal medicine unit over a period of 48 months. The primary goal of this study is to compare the placental contrast ultrasound parameter measurements according to group. The primary objective is to compare placental contrast ultrasound data in women who undergo medical termination of pregnancy at a gestational age of 16 weeks (38+6 days) between two groups: a group with FGR and a group without FGR. The secondary objectives are as follows: (1) to describe the placental vascularisation parameters measured by CEUS; (2) to describe the parameters for quantifying vascularisation at different gestational ages via CEUS; (3) to study the associations between CEUS data and placental histological data and (4) to establish a biological collection of placentas to increase our knowledge of the development and functions of the placenta during pregnancy. The statistical analysis will include descriptive analysis for all study patients, with quantitative data described by means±SDs, medians, IQRs, and extreme values and qualitative data reported as counts and percentages. Comparisons of placental contrast ultrasound parameters between the two groups will be performed via Student’s t-test or the Mann-Whitney U test on the basis of data normality. Associations between CEUS parameters and placental histology data will be analysed with Spearman or Pearson correlations. Qualitative associations will be studied via analysis of variance or the Kruskal-Wallis test. Box plot representations will be used when applicable. Analyses will be performed with R software, with significance set at p

This study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) SUD EST II – LYON – FRANCE, on 26 April 2024, with reference number 2023-506936-34-00, and the competent authority ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) authorised the study on 17 May 2024. The results of this study will be published in a peer-reviewed journal and will be presented at relevant conferences.

NCT06497959; EU CT number: 2023-506936-34-00.

Cervical cancer remains a significant global health concern and is the fourth most prevalent cancer among women. In South Africa, it is the leading cause of cancer-related deaths in women aged 15–44 years. The disease is typically preceded by persistent high-risk HPV infection, leading to cervical intraepithelial neoplasia and eventually cancer. Currently, in South Africa, management primarily involves excision, particularly through large loop excision of the transformation zone, which has associated risks and limitations. Thermal ablation is an alternative cost-effective treatment method, providing a straightforward approach to treatment, particularly advantageous in environments characterised by limited resources. The study aims to assess the efficacy, safety and patient experience of thermal ablation, providing valuable data for potential integration into South Africa’s cervical cancer prevention policies.

Randomised controlled trial in which 420 women living with HIV aged 30–60 years will be recruited from the Colposcopy Clinic at Tygerberg Hospital and will be followed up for a period of two years. The primary study endpoint is a test of cure that will be assessed by HPV genotyping, cervical cytology and histology at six month intervals. Other endpoints include the occurrence of adverse events.

The study protocol has been approved by the Health Research Ethics Committee of Stellenbosch University (Ethics Reference No: M20/11/035) and by the Western Cape Department of Health and Wellness via the National Health Research Database (WC_202109_016). All study procedures comply with the Declaration of Helsinki, South African Good Clinical Practice Guidelines and the Medical Research Council’s ethical guidelines. Trial results will be disseminated through peer-reviewed journals, national and international conference presentations and professional associations. A lay summary will be shared with the Community Advisory Board to guide community-level dissemination.

Pan African Clinical Trial Registry: PACTR202504820339039.

In the UK, each year, approximately 2250 babies are stillborn, and there are an additional 1150 neonatal deaths. The death of a baby before or shortly after birth is a profoundly distressing experience for women and their families and is invariably followed by a period of grief. Most women who have experienced the loss of a baby will embark on another pregnancy, usually within a year. Parents need specialist support from doctors and midwives in a future pregnancy to reduce the risk of pregnancy complications and meet care and support needs. The Rainbow Clinic aims to meet these needs and was first established in 2013 at Saint Mary’s Hospital, Manchester. Initial studies have shown that this model of care improves pregnancy outcomes, decreases anxiety levels and is associated with a strong social return on investment. The Tommy’s National Rainbow Clinic Study aims to evaluate the care provided within this new model, to examine women’s experiences of care and identify areas of improvement and measure the impact on pregnancy outcomes for mothers and babies.

This is a prospective cohort study, measuring a range of maternal and neonatal outcomes following care in Rainbow Clinic. The primary outcome measure is the frequency of stillbirth in the subsequent pregnancy. Measures of maternal well-being include maternal anxiety and psychological symptoms (assessed using Generalised Anxiety Disorder 2-item screening tool (GAD-2), the Cambridge Worry Scale and the Edinburgh Postnatal Depression Scale). Women’s experiences of attending Rainbow Clinic will be recorded on a standardised patient experience tool. Data will be collected on resource use, including the number of appointments with health professionals and the number of ultrasound scans performed. Up to 2000 participants are expected to be enrolled in this study.

This study was given a favourable ethical opinion by the South Central—Hampshire B Research Ethics Committee (Reference 20/SC/0180). The results will be presented at international conferences and published in peer-reviewed open-access journals. Information from this study will inform the development and evaluation of models of specialist antenatal care for pregnancies after stillbirth and neonatal death.

The study is registered with the clinicaltrials.gov under the registration number NCT04393259.

This study aimed to determine the prevalence of non-communicable diseases (NCDs) among pregnant women in Sri Lanka and examine the association between NCDs and maternal and fetal outcomes.

A hospital-based, descriptive cross-sectional study.

The study was conducted in three tertiary care hospitals in the Western Province and one intermediate obstetrics care facility in the Southern Province of Sri Lanka, encompassing diverse, multiethnic populations, over 3 months.

Data from 1350 pregnant women were collected from discharged bed head tickets of the postnatal obstetric wards using a standardised checklist.

The primary outcomes were the prevalence of NCDs. Secondary outcomes included associations between maternal NCDs and adverse fetal outcomes such as preterm births and neonatal complications.

Among the participants, 68.5% (n=926) had one or more NCDs, with anaemia (37.9%), obesity (18.1%), gestational diabetes mellitus (14.9%) and hypertensive disorders (13.6%) being the most prevalent. Women with NCDs were at significantly higher odds of adverse fetal outcomes, including preterm birth (OR=2.3, 95% CI: 1.5 to 3.4), neonatal sepsis (OR=2.5, 95% CI: 1.5 to 4.04) and hypoglycaemia (OR=3.5, 95% CI: 1.2 to 10.0). Maternal complications, including postpartum haemorrhage (3.3%) and placental abruption (0.7%), were also more frequent in this group.

NCDs are highly prevalent among pregnant women in Sri Lanka and are significantly associated with adverse maternal and fetal outcomes. Enhanced screening and management strategies during antenatal care are essential to mitigate risks and improve health outcomes, aligning with global efforts to reduce maternal and neonatal morbidity and mortality.