Vaginal misoprostol versus vaginal dinoprostone for cervical ripening and induction of labour: An individual participant data meta-analysis of randomised controlled trials.

BACKGROUND: Induction of labour (IOL) is common practice and different methods carry different effectiveness and safety profiles. OBJECTIVES: To compare the effectiveness, and maternal and perinatal safety outcomes of IOL with vaginal misoprostol versus vaginal dinoprostone using individual participant data from randomised clinical trials. SEARCH STRATEGY: The following databases were searched from inception to March 2023: CINAHL Plus, ClinicalTrials.gov, Cochrane Pregnancy and Childbirth Group Trial Register, Ovid Embase, Ovid Emcare, Ovid MEDLINE, Scopus and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). SELECTION CRITERIA: Randomised controlled trials (RCTs), with viable singleton gestation, no language restrictions, and all published and unpublished data. DATA COLLECTION AND ANALYSIS: An individual participant data meta-analysis was carried out. MAIN RESULTS: Ten of 52 eligible trials provided individual participant data, of which two were excluded after checking data integrity. The remaining eight trials compared low-dose vaginal misoprostol versus dinoprostone, including 4180 women undergoing IOL, which represents 32.8% of all participants in the published RCTs. Of these, 2077 were assigned to low-dose vaginal misoprostol and 2103 were assigned to vaginal dinoprostone. Compared with vaginal dinoprostone, low-dose vaginal misoprostol had a comparable rate of vaginal birth. Composite adverse perinatal outcomes did not differ between the groups. Compared with vaginal dinoprostone, composite adverse maternal outcomes were significantly lower with low-dose vaginal misoprostol (aOR 0.80, 95% CI 0.65-0.98, P = 0.03, I2 = 0%). CONCLUSIONS: Low-dose vaginal misoprostol and vaginal dinoprostone for IOL are comparable in terms of effectiveness and perinatal safety. However, low-dose vaginal misoprostol is likely to lead to a lower rate of composite adverse maternal outcomes than vaginal dinoprostone.

Surgical Staging of Differentiated Endometrial Cancer: An Analysis of Postoperative Outcome in a Gynecological Cancer Center in Sri Lanka.

INTRODUCTION: Even though surgico-pathological staging is recommended in poorly differentiated endometrial cancer, management of differentiated endometrial cancer is controversial. Preoperative pelvic and abdominal Magnetic Resonance Imaging (MRI) is recommended in well-differentiated endometrial cancer to identify patients with risk factors for regional metastasis. However, access to MRI is limited in Sri Lanka, and surgico-pathological staging is the primary staging method available for most patients with differentiated endometrial cancer. Our objective was to evaluate the outcome of surgical staging among differentiated endometrial cancer patients who underwent primary surgery at the gynecological cancer center of Apeksha Hospital Maharagama, Sri Lanka. METHODS: A retrospective study was conducted using the ongoing electronic database at the gynecological cancer center of the National Cancer Institute (Apeksha Hospital) in Maharagama, Sri Lanka. Data from December 2019 to December 2020 were selected for analysis. RESULTS: During the study period, 112 patients with endometrial cancer underwent hysterectomy. This study included 90 patients with differentiated endometrial cancer (International Federation of Gynecology and Obstetrics [FIGO] Grade 1 and Grade 2), out of which pelvic lymph node dissection was performed in 78 (86.7%) cases. Among the 90 patients, 54 (60%) had medical comorbidities. It was reported that 35% (n=32) of the patients had myometrial invasion of more than 50% thickness. Furthermore, 13.8% of patients with deep myometrial invasion had lymph node metastasis, while only one patient (2%) in the superficial or no myometrial invasion group had lymph node metastasis. Therefore, the absence of deep myometrial invasion has a negative predictive value of around 98% for excluding pelvic lymph node metastasis. CONCLUSION: Approximately one in seven patients with deeply infiltrating differentiated endometrial cancer had lymph node metastasis. In limited resource settings where preoperative pelvic MRI is not readily available, implementing a policy of routine surgical pelvic lymph node assessment would be beneficial. This approach would aid in detecting stage IIIc disease and also help avoid unnecessary pelvic irradiation.

Clarifying the unmet clinical need during medical device innovation in women's health - A narrative review.

Medical technologies are pervasive across women's health, spanning across obstetric and gynecological care. FemTech, the sector responsible for developing these technologies, is growing at 15.6% per annum. However, there are concerns of disconnects between new product development (NPD) and the care afforded to women in consequence of implementing these innovations. The most crucial stage of NPD involves understanding the clinical need. Without a clear need and clinical use case, innovators risk developing solutions which do not address the issues women and caregivers experience. Thus, the product will miss the market and experience limited uptake. Tools for performing clinical needs assessments and defining the use case are being developed. This review provides an analysis of their strengths and weaknesses to inform FemTech innovators of the available resources. We further discuss concepts for creating a unified approach to assessing unmet needs such that technologies have a higher chance of improving women's healthcare.

The sustained adverse impact of COVID-19 pandemic on mental health among pregnant women in Sri Lanka: a reassessment during the second wave.

OBJECTIVE: To study the change in trend of antenatal mental health and associated factors among a cohort of pregnant women during the second wave of COVID-19 using Hospital Anxiety and Depression Scale (HADS). Previous study using the same scale, during the first wave reported a higher prevalence of anxiety and depression. RESULTS: A descriptive cross-sectional study was carried out at the two large maternity hospitals in Colombo, Sri Lanka: Castle Street Hospital for Women (CSHW) and De Soysa Hospital for Women (DSHW). Consecutively recruited 311 women were studied. Out of which, 272 (87.5%) were having uncomplicated pregnancies at the time of the survey and 106 (34.1%) were either anxious, depressed, or both. Prevalence of anxiety was 17.0% and depression 27.0%. Overall, continuing COVID-19 pandemic increased antenatal anxiety and depression. The trend was to aggravate depression more intensively compared to anxiety in this cohort of women studied. Special support is needed for pregnant mothers during infectious epidemics taking more attention to antenatal depression.

Predicting the success of induction of labour using cervical volume.

OBJECTIVES: Assessing the likelihood of success of induction of labour using cervical volume is an important research question. DATA DESCRIPTION: We provide data generated in a prospective observational study which was carried out at North Colombo Teaching Hospital, Ragama, Sri Lanka. Study conducted to compare pre-induction digital cervical assessment, sonographic cervical length, and sonographic cervical volume with vaginal delivery rate within 24 h. Inductions with 100 singleton pregnancies at term were included.

The Potential Impact of COVID-19 Pandemic on the Antenatal Care as Perceived by Non-COVID-19 Pregnant Women: Women's Experience Research Brief.

We aimed to study the impact of Coronavirus disease 2019 (COVID-19) pandemic on the basic antenatal care received during the. A facility-based descriptive cross-sectional study was conducted and 62 pregnant women were interviewed. A total of 80.6% of mothers were satisfied with the quality of antenatal care they received, ≥ 7 of 10 on visual analogue scales (VAS). The majority of women were not confident to deliver their baby and 58.1% of women showed ≤ 5 of 10 on VAS. Midwife (90.3%) was the commonest source of information. Internet (1.6%) was a poor source. The impact of the COVID-19 pandemic on the quality of antenatal care was significant, and the findings are useful for the policymakers to plan necessary actions.

Perceptions on respectful maternity care in Sri Lanka: Study protocol for a mixed-methods study of patients and providers.

BACKGROUND: Over the past few decades, interest in providing and measuring Respectful Maternity Care (RMC) has increased markedly. Sri Lanka is reportedly shown to have better maternal health statistics and studies on quality improvement are lacking in this unique population. We aim to describe healthcare providers' perceptions and women's expectations, perceptions and their gaps in service provision regarding RMC in Sri Lanka. METHODS: A descriptive cross-sectional study with a mixed-methods approach comprising of qualitative component followed by a quantitative component will be conducted in Castle Street Hospital for Women (CSHW) and De Soysa Hospital for Women (DSHW), Colombo, Sri Lanka. Healthcare providers (HCP- doctors, nurses and midwives) and vaginally delivered postnatal women (in postnatal wards and postnatal well-baby clinics) will be recruited through convenience sampling. In-depth interviews will be conducted with each of the four categories. Thematic analysis will be adopted to analyze qualitative data and the findings will further be used to improve the quantitative phase questionnaires. Self-administered questionnaire will be administered to a 378 vaginally delivered postnatal women [quota sampling across ten wards], exploring demographic details, and maternal opinion on various aspects of RMC. Locally validated Women's Perceptions of RMC tool (WP-RMC) will also be used to measure the level of RMC among these postnatal women along with the questionnaire 01. Qualitative findings will be used for cognitive validation of the WP-RMC into the Sri Lankan setting. DISCUSSION: This study will explore HCP's and women's expectations, perceptions and their gaps in service provision regarding RMC in two maternity hospitals in Sri Lanka. Assessment of the quality of care with regards to RMC have not been reported previously in this setting.

Surgical management of cervical cancer in a resource-limited setting: One year of data from the National Cancer Institute, Sri Lanka.

OBJECTIVE: To evaluate the surgical management of cervical cancer without the use of preoperative pelvic imaging in a resource-limited setting. METHODS: A retrospective study was carried out using clinical records and the ongoing electronic database at the Gynaecological Oncology Unit, National Cancer Institute (Apeksha Hospital), Maharagama, Sri Lanka. Details regarding the radical hysterectomies carried out from January 1, 2019, to December 31, 2019, were retrospectively studied. RESULTS: Out of nearly 700 patients with cervical cancer admitted during the year 2019, 57 surgically managed radical hysterectomies were included. Of these, seven cases were ineligible and excluded and 50 cases of radical hysterectomies were included for analysis. Mean age was 53.6 ± 9.5 years and median parity was 3 (range 2-4). Of the cases, 94% were found to have no parametrial involvement showing the success of clinical examination in assessing local tumor spread. Overall, 11 (22.0%) were upstaged due to lymph node metastasis that was statistically significant. CONCLUSION: Preoperative clinical staging is a practical method in selecting surgically treatable cervical cancer in low- and middle-income countries (LMICs). Combining clinical assessment with comparatively more readily available computed tomography scans could be helpful in triaging patients for treatment of cervical cancer in LMICs.

Childbirth Experience Questionnaire (CEQ) in the Sri Lankan setting: translation, cultural adaptation and validation into the Sinhala language.

OBJECTIVE: To adapt the CEQ into Sri Lankan Sinhala cultural context and to determine the psychometric properties of CEQ. This would yield an opportunity to evaluate childbirth experience among Lankan population. RESULTS: Out of 390, 226 (57.9%) postnatal mothers completed the CEQ after 1 month postpartum. Face validity and content validity were demonstrated with all participants stating that CEQ was easy to understand and complete. For reliability, internal consistency was acceptable for the overall score (0.85) and for all four domains in CEQ (0.65, 0.80, 0.70, 0.83 for "own capacity", "professional support", "perceived safety" and "participation", respectively). A weighted kappa of 0.61-0.80 for all 22 items in CEQ demonstrated a good test-retest reliability. This Sri Lankan version showed fit statistics in line with standard recommendations in exploratory factor analysis. Women with spontaneous onset of labour (except for "professional support" in women with spontaneous onset of labour) and women with a normal birth showed significantly higher CEQ scores. However, oxytocin augmentation could not yield a difference in CEQ scores.

Ultrasound parameters of pelvic organs and their age-related changes in a cohort of asymptomatic postmenopausal women: A community-based study.

OBJECTIVE: To describe the ultrasound parameters of pelvic organs and their age-related changes in a cohort of asymptomatic postmenopausal women and to describe the prevalence of ultrasound-detected pathologies in a Sri Lankan population. STUDY DESIGN: A large community-based longitudinal study using a randomly selected sample of postmenopausal women who have never used hormone replacement therapy. MAIN OUTCOME MEASURES: Uterine, endometrial and ovarian measurements at pelvic ultrasonography as described by the International Endometrial Tumor Analysis and the International Ovarian Tumor Analysis groups. RESULTS: A total of 815 postmenopausal women were approached and all volunteered to participate. This included women between the ages of 45 and 74 years with a median (interquartile range (IQR)) of 62.0 (10.0) years. The median (IQR) uterine volume was 18.1 (17) ml, while the median (IQR) of right and left ovarian volumes were 17.3 (22.9) ml and 18.2 (21.5) ml. Both uterine and ovarian volumes showed an age-related decline (p < 0.01). Furthermore, the ovarian volumes demonstrated an increase in size with a higher body mass index (p < 0.03 for left and p < 0.01 for right, respectively). Median (IQR) endometrial thickness among the population was 3.0 (1.0) mm and there was no age-related change observed. Sixty-one women had an ultrasound-detected gynaecological pathology with a prevalence of 7.5% (95% confidence interval (CI) 5.6-9.5). CONCLUSIONS: This study aimed at describing ultrasound parameters of pelvic organs among postmenopausal women of Sri Lanka was able to provide the reference values for uterine and ovarian volume among asymptomatic postmenopausal women. Both uterine and ovarian volumes demonstrated an age-related decline, whereas the endometrial thickness does not seem to relate to the age.

Childbirth Experience Questionnaire (CEQ): research proposal for translation and validation into Sinhala language among a Lankan cohort of women.

INTRODUCTION: The Childbirth Experience Questionnaire (CEQ) is a Sweden origin, self-administered questionnaire to assess birth satisfaction of women in different aspects of their first labour and birth. It measures four main domains of the woman's childbirth experience. Those are own capacity, professional support, perceived safety and participation, comprising of 22 items. OBJECTIVES: To conduct a linguistic translation, to conduct a validation study and to assess the psychometric properties of the Sinhala version of the CEQ.

Experience with a context-specific modified WHO safe childbirth checklist at two tertiary care settings in Sri Lanka.

BACKGROUND: The aim of the study was to assess whether a more context-specific modified version of WHO Safe Childbirth Checklist (mSCC) would result in improved adoption rate. METHODS: A prospective observational study was conducted in University Obstetrics Unit at De Soysa Hospital for Women (DSHW), Colombo and two Obstetric Units at Teaching Hospital, Mahamodara, Galle (THMG), Sri Lanka. Study was conducted over 8 weeks at DSHW and over 4 weeks at THMG after introduction of the mSCC in 2017. The WHO SCC was in use at DSHW from 2013 until its replacement by the mSCC. Checklists were kept attached at admission and collected on discharge. Level of acceptance was assessed using a self-administered questionnaire at the end. Outcome measures were adoption rate (percentage of deliveries where mSCC was used and could be found), adherence to practices (mean percentage of items checked), response rate (percentage of staff members responded to questionnaire) and level of acceptance (percentage of "strongly agree/agree" in Likert scale to five questions regarding acceptance of mSCC). Responses were also taken to the open-ended question on barriers to implementation. RESULTS: In DSHW, out of 606 births during study period, there were 329 live births in which the mSCC was used and could be found giving an adoption rate of 54.3%. In THMG adoption rate was 153/814 (18.8%). In DSHW, response rate for the questionnaire was 40.5% and in THMG, 40.0%. Level of acceptance was good among those who responded to the questionnaire. Mean (95% CI) adherence to the Checklist practices was 52.7% (44.1-58.5) in DSHW and 32.2% (24.5-39.1) in THMG with a range of 1-100% in both settings. Majority mentioned the lack of staff, lack of enthusiasm, inadequate training and advice on use of mSCC and lack of supervision from Ministry/institutional level. Majority suggested the involvement of medical doctors, removal of the need to place the signature and separate accountability to each 27-items and the desirability of proper training sessions regarding the mSCC. CONCLUSION: Checklist-based interventions in maternity care cannot be expected to improve by merely making them context-specific. Other approaches should be explored to maximize its benefits.

Hyperglycemia in pregnancy among South Asian women: A single tertiary care center experience from Colombo, Sri Lanka.

AIM: To study case mix, risk factors, adverse outcomes and associations of hyperglycemia in pregnancy in a cohort of Sri Lankans. METHODS: Prospective observational study, from April 2011-October 2015 at a tertiary care referral center, Colombo, Sri Lanka. Data from first trimester to delivery of HIP was analyzed. Three subgroups were defined: Diabetes in pregnancy (DIP), Hyperglycemia in early Pregnancy (HIEP) [<24 weeks] and Gestational diabetes (GDM) [>24 weeks]. RESULTS: Of 782 patients 572 (73.1%) had complete data. Case-mix: 137(24.0%) DIP, 331(57.9%) GDM and 104 (18.2%) HIEP. Primigravidae commoner in GDM (<0.05). DIP older - mean 33.3 ±â€¯5.5 years (<0.01). Previous GDM commoner and pharmacological interventions needed in DIP and HIEP. Majority GDM (66.8%) required Medical Nutrition Therapy (MNT) alone. There was no difference in pregnancy outcomes between the 3 subgroups. Macrosomia significantly greater in HIEP (33.7%); neonatal cardiac defects more in DIP and HIEP. CONCLUSIONS: Increasing maternal age is a significant risk for DIP, while previous GDM is a risk for DIP and HIEP and neonatal congenital cardiac defects in subsequent pregnancies of South Asian women. We recommend preconception screening for glucose intolerance and achieving normoglycaemia among South Asian women with advanced maternal age and previous GDM.

Validation of the International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) in two south- Asian languages.

INTRODUCTION: The multifaceted nature of pelvic floor disorders means that a systematic evaluation is required for optimal treatment outcome. It is also generally acknowledged that a valid tool is necessary to objectively assess symptoms reported by affected women. METHODS: The International Consultation on Incontinence Questionnaire-Vaginal Symptoms (ICIQ-VS) questionnaire was translated to Sinhala and Tamil and a validation study carried out among women attending gynecology clinics at North Colombo Teaching Hospital, Ragama, and the district general hospitals Mannar and Vavuniya. RESULTS: Content validity was assessed by the level of missing answers, which was < 4% and 2% for each item in Sinhala and Tamil, respectively. Construct validity was assessed by the ability of the questionnaire to differentiate between patients and controls. Both differentiated patients from controls on vaginal symptoms score (VSS) (p < 0.001), sexual symptoms score (SSS) (p < 0.01), and quality of life (QoL) (p < 0.001). There was a strong positive correlation between Pelvic Organ Prolapse Quantification (POP-Q) scores and VSS (Sinhala r s = 0.64, p < 0.001, Tamil r s = 0.65, p < 0.001), and QoL (Sinhala r s = 0.49, p < 0.001, Tamil r s = 0.60, p < 0.001). Internal consistency as assessed using Cronbach's coefficient alpha: 0.78 (0.76-0.78) and 0.83 (0.80-0.84) in Sinhala and Tamil, respectively. Test-retest reliability was assessed by weighted kappa scores (Sinhala 0.58-0.88 and Tamil 0.76-0.90). Both questionnaires were sensitive to change and showed that VSS and QoL improved following surgery (Wilcoxon matched-pairs signed-rank test p < 0.001). CONCLUSION: The validated Sinhala and Tamil translations of ICIQ-VS will be useful for assessing vaginal and sexual symptoms among women speaking Sinhala and Tamil.

Implementation of the WHO safe childbirth checklist program at a tertiary care setting in Sri Lanka: a developing country experience.

BACKGROUND: To study institutionalization of the World Health Organization's Safe Childbirth Checklist (SCC) in a tertiary care center in Sri Lanka. METHOD: A hospital-based, prospective observational study was conducted in the De Soysa Hospital for Women, Colombo, Sri Lanka. Healthcare workers were educated regarding the SCC, which was to be used for each woman admitted to the labor room during the study period. A qualitatively pretested, self-administered questionnaire was given to all nursing and midwifery staff to assess knowledge and attitudes towards the checklist. Each item of the SCC was reviewed for adherence. RESULTS: A total of 824 births in which the checklist used were studied. There were a total of births 1800 during the period, giving an adoption rate of 45.8%. Out of the 170 health workers in the hospital (nurses, midwives and nurse midwives) 98 answered the questionnaire (response rate = 57.6%). The average number of childbirth practices checked in the checklist was 21 out of 29 (95% CI 20.2, 21.3). Educating the mother to seek help during labor, after delivery and after discharge from hospital, seeking an assistant during labor, early breast-feeding, maternal HIV infection and discussing contraceptive options were checked least often. The mean level of knowledge on the checklist among health workers was 60.1% (95% CI 57.2, 63.1). Attitudes for acceptance of using the checklist were satisfactory. Average adherence to checklist practices was 71.3%. Sixty eight (69.4%) agreed that the Checklist stimulates inter-personal communication and teamwork. Increased workload, poor enthusiasm of health workers towards new additions to their routine schedule and level of user-friendliness of Checklist were limitations to its greater use. CONCLUSIONS: Amongst users, the attitude towards the checklist was satisfactory. Adoption rate amongst all workers was 45.8% and knowledge regarding the checklist was 60.1%. These two factors are probably linked. Therefore prior to introducing it to a facility awareness about the value and correct use of the SCC needs to be increased, while giving attention to satisfactory staffing levels.

Acute subdural haemorrhage in the postpartum period as a rare manifestation of possible HELLP (haemolysis, elevated liver enzymes, and low-platelet count) syndrome: a case report.

BACKGROUND: The HELLP syndrome (haemolysis, elevated liver enzymes, and low-platelet count) occurs in about 0.5 to 0.9% of all pregnancies. With occurrence of thrombocytopaenia, it signals for several potentially lethal conditions such as complete or partial HELLP syndrome, thrombotic thrombocytopaenic purpura and acute fatty liver of pregnancy. CASE PRESENTATION: A previously healthy 27-year-old, Sinhala ethnic primigravida with pregnancy-induced hypertension was admitted at 38 weeks of gestation with lower abdominal pain and a blood pressure of 140/90 mmHg. She underwent emergency Caesarian section due to faetal distress giving birth to a healthy baby girl. Since postpartum day one, she was having intermittent fever spikes. All the routine investigations were normal in the first three weeks. Platelet count started dropping from post-partum day-20 onwards. On day-23, she had developed a seizure and computed tomography scan brain showed a subdural haemorrhage. She had a platelet count of 22,000 × 109/liter and was managed conservatively. She also had elevated liver enzymes, lactate dehydrogenase and bilirubin levels. Blood picture on day-24 showed haemolytic anemia. On day- 36, patient again developed seizures and she was having intermittent fever with generalized headache and signs of meningism. Computed tomography scan revealed an acute on chronic subdural haemorrhage. CONCLUSIONS: Hypertensive disorders in pregnancy should be managed as high-risk throughout the postpartum period. Development of thrombocytopaenia can be considered as an early warning sign for HELLP, thrombotic thrombocytopaenic purpura or acute fatty liver of pregnancy which are lethal conditions. Prompt recognition of intracranial haemorrhages and early neurosurgical intervention is lifesaving.