ResearchPad - Obstetrics and Gynaecology https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial]]> https://www.researchpad.co/product?articleinfo=N9a74d38b-4fa0-4bfe-baf9-0531a63934a2

Introduction

Current pharmacological treatment options for hyperemesis gravidarum have been introduced based on scarce evidence and are often not sufficiently effective. Several case reports suggest that mirtazapine, an antidepressant, may be an effective treatment for hyperemesis gravidarum, but so far there are no controlled trials investigating the potential effect of mirtazapine on hyperemesis gravidarum. The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women. This study aims to investigate the effect of mirtazapine on hyperemesis gravidarum while also providing data on the effect of ondansetron.

Methods and analysis

This randomised double-blind placebo-controlled multicentre trial will be conducted in eight Danish hospitals. One hundred and eighty pregnant women referred to secondary care for hyperemesis gravidarum will be randomly allocated to 14-day treatment with either mirtazapine, ondansetron or placebo. Main inclusion criterion will be Pregnancy Unique Quantification of Emesis (PUQE-24) score ≥13 or PUQE-24 score ≥7 if accompanied by weight loss >5% of pre-pregnancy weight or hospitalisation. Participants are eligible regardless of whether other antiemetics, including ondansetron, have been tried. The coprimary outcomes are effects of mirtazapine and ondansetron, respectively, on PUQE-24 score tested hierarchically on day 2 and day 14. Secondary outcomes include, but are not limited to, differences between the three groups in number of daily vomiting episodes, dropout due to treatment failure, use of rescue medication, weight change and side effects.

Ethics and dissemination

The trial has been approved by the Regional Committees on Health Research Ethics in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. Results will be published in peer-reviewed journals and submitted to relevant conferences.

Trial registration number

NCT03785691

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<![CDATA[Obstetrical safety indicators for preventing hospital harms in low risk births: a scoping review protocol]]> https://www.researchpad.co/product?articleinfo=Nce9bc2e8-7822-42ff-b05c-47735ed1d1d2

Introduction

Optimising the safety of obstetric patient care is a primary concern for many hospitals. Performance indicators measuring aspects of patient care processes can lead to improvements in health systems and the prevention of harm to the patient. We present our protocol for a scoping review to identify indicators for obstetric safety in low risk births. We aim to identify indicators addressing preventable hospital harms, to summarise the data and synthesise results.

Methods and analysis

We will use methods described by Arksey and O’Malley and further expanded by Levac et al. We will search electronic databases such as Medline, Embase, CINAHL and the Cochrane Library, and websites from professional bodies and other organisations, using an iterative search strategy.

Two reviewers will independently screen titles and abstracts of search results to determine eligibility for inclusion. If eligibility is not clear, the reviewers will screen the full text version. If reviewers’ decisions regarding eligibility differ, a third reviewer will review the record. Two reviewers will independently extract data from records that meet our inclusion criteria using a standardised data collection form. We will narratively describe quantitative data, such as the frequency with which indicators are identified, and conduct a thematic analysis of the qualitative data. We will compile a comprehensive list of patient safety indicators and organise them according to concepts that best suit the data such as the Donabedian model or the Hospital Harm Framework. We will discuss the implications for future research, clinical practice and policy-making. We will report the conduct of the review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews checklist.

Ethics and dissemination

The sources of information included in this scoping review will be available to the public. Therefore, ethics approval is not warranted. We will disseminate results in a peer-reviewed publication, conference/event presentation(s) and stakeholder communications.

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<![CDATA[Assessing the feasibility of a rapid, high-volume cervical cancer screening programme using HPV self-sampling and digital colposcopy in rural regions of Yunnan, China]]> https://www.researchpad.co/product?articleinfo=Na1938780-1871-4a9a-bc94-3abb2c0992bc

Objective

Implementation of a novel, rapid, high-volume, see-and-treat cervical cancer screening programme using self-swab human papillomavirus (HPV) testing and digital colposcopy in underserved regions of Yunnan China.

Design

480–980 women per day self-swabbed for high-risk HPV (hrHPV+). Four careHPV machines (Qiagen) were run simultaneously to test the specimens. All hrHPV+ patients were contacted the same day and digital colposcopy was performed with the enhanced visual assessment system (MobileODT). Digital images were obtained, and all suspected lesions were biopsied and then treated.

Setting

Rural and underserved areas of the Yunnan province, Kunming municipality.

Participants

3600 women, mean age 50.2 years, who had never been screened for cervical cancer. The women were of the Yi, Hui, Dai and Han ethnicities.

Interventions

Cryotherapy was performed on all lesions suspicious for cervical intraepithelial neoplasia (CIN) 1 and loop electrosurgical excision procedure was performed on all lesions suspicious for ≥CIN2. Endocervical curettage was performed if the transformation zone was not fully visualised.

Results

216 women (6%) were hrHPV+. 168 underwent same-day colposcopy (23 CIN1, 17≥CIN2). Digital colposcopy was able to identify 15 of 16 (93.8%)≥CIN2 lesions.

Conclusions

This study illustrates a high-volume, rapid and practical strategy that can be used to screen and treat an ethnically diverse group of Chinese women. First, HPV self-sampling allows large numbers of women to be screened rapidly and relatively inexpensively. Only hrHPV+ women will then require further evaluation. Digital colposcopy is then performed on hrHPV+ women with a portable digital colposcope. The high-resolution images obtained can facilitate appropriate same-day treatment as they are able to accurately distinguish between CIN1 and ≥CIN2 lesions.

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<![CDATA[Association between uterine contractions before elective caesarean section and transient tachypnoea of the newborn: a retrospective cohort study]]> https://www.researchpad.co/product?articleinfo=N4ecee3f1-fc56-4948-88ad-70febdcc0af2

Objective

We evaluated the association between the presence of predelivery uterine contractions and transient tachypnoea of the newborn (TTN) in women undergoing an elective caesarean section.

Design

A retrospective cohort study.

Setting

National Hospital Organization Kofu National Hospital, which is a community hospital, between January 2011 and May 2019.

Participants

The study included 464 women who underwent elective caesarean section. The exclusion criteria were missing data, twin pregnancy, neonatal asphyxia, general anaesthesia and elective caesarean section before term.

Primary and secondary outcome measures

Patients were grouped according to the presence or absence of uterine contractions on a 40-min cardiotocogram (CTG) performed within 6 hours before caesarean delivery. We performed a multivariable logistic regression analysis to examine the association between predelivery uterine contractions and TTN.

Results

The incidence of TTN was 9.9% (46/464), and 38.4% (178/464) of patients had no uterine contraction. The absence of uterine contractions was significantly associated with an increased risk of TTN (adjusted OR 2.04; 95% CI 1.09 to 3.82) after controlling for gestational diabetes mellitus, small for gestational age, male sex and caesarean section at 37 weeks.

Conclusions

Accurate risk stratification using a CTG could assist in the management of infants who are at risk of developing TTN.

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<![CDATA[Psychometric properties of the Breast Cancer Awareness Measurement among Chinese women: a cross-sectional study]]> https://www.researchpad.co/product?articleinfo=Nfe38a738-cddc-4bf8-861b-fe5fedfd549e

Objectives

To perform the cross-cultural adaption of the Breast Cancer Awareness Measurement (BCAM) and to test its psychometric properties among Chinese women.

Design

This is a cross-sectional study.

Settings

This study was conducted in communities, schools and institutions in Changchun, Jilin Province, China.

Participants

A total of 328 women voluntarily participated in and completed the Chinese version of the BCAM (C-BCAM), resulting in an effective response rate of 91.1%.

Primary and secondary outcome measures

Psychometric properties, including item analysis (the extreme group comparison and item-total correlations), content validity (item-level content validity index (I-CVI) and scale-level content validity index (S-CVI)), construct validity (exploratory factor analysis (EFA) and confirmatory factor analysis (CFA)) and internal consistency (Cronbach’s α and test–retest reliability), were measured.

Results

The C-BCAM has excellent internal consistency (Cronbach’s α=0.90), with alpha coefficients of 0.88, 0.84 and 0.94 for its three domains. The test–retest reliability coefficient was 0.72. The I-CVI ranged from 0.86 to 1.00, and the S-CVI was 0.92. CFA showed that the three-factor model explained 51.56% of the total variance, with a good model fit (likelihood ratio χ2/df=1.86, incremental fit index=0.94, comparative fit index=0.94, goodness-of-fit index=0.84, adjusted goodness-of-fit index=0.80, standardised root mean square error of approximation=0.06 and root mean square residual=0.05).

Conclusions

The C-BCAM has satisfactory validity and reliability and is a culturally appropriate and reliable tool for evaluating breast cancer awareness among Chinese women. This reliable instrument can help researchers and health professionals evaluate women’s knowledge about the symptoms and risk factors of breast cancer and identify their barriers to seeking medical help. It also helps healthcare providers identify women with poor breast cancer awareness and encourage them to perform screening practice.

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<![CDATA[Do recent immigrants have similar obstetrical care and perinatal complications as long-term residents? A retrospective exploratory cohort study in Brussels]]> https://www.researchpad.co/product?articleinfo=N5214db24-4b84-4f63-b45a-c6e6673354bb

Purpose

Recent immigrants (RIs) face various barriers affecting quality of care. The main research question assessed whether perinatal complications (during pregnancy, labour, delivery and neonatal period) were similar in RIs to those in long-term residents (LTRs). The secondary question assessed whether prenatal and perinatal care was similar in the two groups.

Methods

This is a monocentric observational study, carried out in Brussels between November 2016 and March 2017 (n=1365). We surveyed 892 pregnant women during prenatal consultations and immediate postpartum period in order to identify RIs of less than 3 years (n=230, 25%) and compared them with LTRs (n=662). Sociodemographic data, baseline health status, prenatal care, obstetrical and neonatal complications were compared between these two groups. Multivariable binary logistic regression was conducted to examine the occurrence of perinatal complications (during pregnancy, labour and delivery, and neonatal period) between RIs and LTRs after adjustment for potential confounders.

Results

RIs were living more frequently in precarious conditions. RIs were younger (p<0.001) and had a lower body mass index (p<0.001) than LTRs. Prenatal care was often delayed in RIs, resulting in fewer evaluations during the first trimester (p<0.001). They had a lower prevalence of gestational diabetes mellitus (p<0.05) and less complications during the pregnancy even after adjustment for confounding factors. Similar obstetrical care during labour and delivery occurred. After adjustment for confounding factors, no differences in labour and delivery complications were observed. Although RIs’ newborns had a lower umbilical cord blood pH (<0.05), a lower 1 min of life Apgar score (p<0.01) and more frequently required respiratory assistance (p<0.05), no differences in the composite endpoint of neonatal complications were observed. No increase in complications in the RI group was detected whatever the considered period.

Conclusion

RIs had less optimal prenatal care but this did not result in more obstetrical and perinatal complications.

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<![CDATA[Protocol for a longitudinal, prospective cohort study investigating the biology of uterine fibroids and endometriosis, and patients’ quality of life: the FENOX study]]> https://www.researchpad.co/product?articleinfo=N861ced44-96d3-48d9-84bb-216b3964a0eb

Introduction

Millions of women suffer from the consequences of endometriosis and uterine fibroids, with fibroids the cause for over 50% of hysterectomies in the USA, and direct costs for their treatment estimated at between US$4 and US$9 billion. Endometriosis commonly affects millions of women worldwide predominantly during reproductive age, with severe menstrual and non-menstrual pain and subfertility the main symptoms. Due to the ‘unhappy triad’ of endometriosis—lack of awareness, lack of clinically relevant biomarkers and the unspecific nature of symptoms—women wait on average for 8–12 years before the definitive endometriosis diagnosis is made. Treatment options for both conditions are not satisfactory at the moment, especially with a view to preserving fertility for the women and families affected. In the Fibroids and Endometriosis Oxford (FENOX) study, we combine the investigation of fibroids and endometriosis, and plan to collect high-quality tissue samples and medical data of participants over a time frame of 5 years after surgical intervention.

Methods and analysis

Biological samples such as blood, saliva, urine, fat, peritoneal fluid and—if found—endometrial tissue or fibroids as well as detailed clinical and intraoperative data will be collected from women undergoing surgery and participating in the study after informed consent. We plan to recruit up to 1200 participants per disease arm (ie, endometriosis and uterine fibroids) over 5 years. Participants will fill in detailed and validated questionnaires on their medical history and quality of life, with follow-ups for 5 years. Enrolment started on 2 April 2018, and FENOX will close on 31 March 2028. We will analyse the biological samples using state-of-the-art molecular biology methods and correlate the findings with the medical records and questionnaire data.

Ethics and dissemination

The findings will be published in high-ranking journals in the field and presented at national and international conferences.

Trial registration number

ISRCTN13560263.

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<![CDATA[Outcome of the 2016 United States presidential election and the subsequent sex ratio at birth in Canada: an ecological study]]> https://www.researchpad.co/product?articleinfo=N79d9a3d2-cdd5-45c0-92f9-b3169cfe4684

Objectives

The sex ratio at birth (proportion of boys to girls) generally shows slight male preponderance but may decrease in response to societal stressors. Discrete adverse events such as terrorist attacks and disasters typically lead to a temporary decline in the sex ratio 3–5 months later, followed by resolution over around 5 months thereafter. We hypothesised that the unexpected outcome of the 2016 US presidential election may have been a societal stressor for liberal-leaning populations and thereby precipitated such an effect on the sex ratio in Canada.

Design

Ecological study.

Setting

Administrative data for Ontario (Canada’s most populous province).

Participants

All births in Ontario from April 2010 to Oct 2017 inclusive (n=1 079 758).

Primary and secondary outcome measures

We determined the sex ratio at birth in Ontario for each month from April 2010 to October 2017 and performed segmented regression analysis to evaluate the seasonally adjusted sex ratio for the following three time periods: before the November 2016 election; after the election to before the anticipated impact; and from anticipated impact to 5 months thereafter.

Results

In the 12 months following the election, the lowest sex ratio occurred in March 2017 (4 months post election). Compared with the preceding months, the sex ratio was lower in the 5 months from March to July 2017 (p=0.02) during which time it was rising (p=0.01), reflecting recovery from the nadir. Both effects were seen in liberal-leaning regions of Ontario (lower sex ratio (p=0.006) and recovery (p=0.002) in March–July 2017) but not in conservative-leaning areas (p=0.12 and p=0.49, respectively).

Conclusion

The 2016 US presidential election preceded a temporary reduction in the sex ratio at birth in Canada, with the time course of changes therein matching the characteristic pattern of a discrete societal stressor.

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<![CDATA[mHealth: providing a mindfulness app for women with chronic pelvic pain in gynaecology outpatient clinics: qualitative data analysis of user experience and lessons learnt]]> https://www.researchpad.co/product?articleinfo=N6e09e33f-47a1-4d53-a0eb-20fdbf432668

Objectives

To determine whether a pre-existing smartphone app to teach mindfulness meditation is acceptable to women with chronic pelvic pain (CPP) and can be integrated into clinical practice within the National Health Service (NHS) CPP pathways, and to inform the design of a potential randomised clinical trial.

Design

A prestudy patient and public involvement (PPI) group to collect feedback on the acceptability of the existing app and study design was followed by a three-arm randomised feasibility trial. In addition, we undertook interviews and focus groups with patients and staff to explore app usability and acceptability. We also obtained participant comments on the research process, such as acceptability of the study questionnaires.

Setting

Two gynaecology clinics within Barts Health NHS, London, UK.

Participants

Patients with CPP lasting ≥6 months with access to smartphone or personal computer and understanding of basic English.

Intervention

The intervention was mindfulness meditation content plus additional pain module delivered by a smartphone app. Active controls received muscle relaxation content from the same app. Passive (waiting list) controls received usual care.

Main outcome measures

Themes on user feedback, app usability and integration, and reasons for using/not using the app.

Results

The use of the app was low in both active groups. Patients in the prestudy PPI group, all volunteers, were enthusiastic about the app (convenience, content, portability, flexibility, ease of use). Women contributing to the interview or focus group data (n=14), from a ‘real world’ clinic (some not regular app users), were less positive, citing as barriers lack of opportunities/motivation to use the app and lack of familiarity and capabilities with technology. Staff (n=7) were concerned about the potential need for extra support for them and for the patients, and considered the app needed organisational backing and peer acceptance.

Conclusion

The opinions of prestudy PPI volunteers meeting in their private time may not represent those of patients recruited at a routine clinic appointment. It may be more successful to codesign/codevelop an app with typical users than to adapt existing apps for use in real-world clinical populations.

Trial registration number

ISRCTN10925965.

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<![CDATA[MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial]]> https://www.researchpad.co/product?articleinfo=Ndd46e576-a167-4af4-ac7e-97abfd1653b9

Objectives

To evaluate the feasibility of a randomised trial of a modified, pre-existing, mindfulness meditation smartphone app for women with chronic pelvic pain.

Design

Three arm randomised feasibility trial.

Setting

Women were recruited at two gynaecology clinics in the UK. Interventions were delivered via smartphone or computer at a location of participants choosing.

Participants

Women were eligible for the study if they were over 18, had been experiencing organic or non-organic chronic pelvic pain for 6 months or more, and had access to a computer or smartphone. 90 women were randomised.

Interventions

Daily mindfulness meditation delivered by smartphone app, an active control app which delivered muscle relaxation techniques, and usual care without app. Interventions were delivered over 60 days.

Primary and secondary outcome measures

Outcomes included length of recruitment, follow-up rates, adherence to the app interventions, and clinical outcomes measured at baseline, two, three and 6 months.

Results

The target sample size was recruited in 145 days. Adherence to the app interventions was extremely low (mean app use 1.8 days mindfulness meditation group, 7.0 days active control). Fifty-seven (63%) women completed 6-month follow-up, and 75 (83%) women completed at least one postrandomisation follow-up. The 95% CIs for clinical outcomes were consistent with no benefit from the mindfulness meditation app; for example, mean differences in pain acceptance scores at 60 days (higher scores are better) were −2.3 (mindfulness meditation vs usual care, 95% CI: −6.6 to 2.0) and −4.0 (mindfulness meditation vs active control, 95% CI: −8.1 to 0.1).

Conclusions

Despite high recruitment and adequate follow-up rates, demonstrating feasibility, the extremely low adherence suggests a definitive randomised trial of the mindfulness meditation app used in this study is not warranted. Future research should focus on improving patient engagement.

Trial registration numbers

NCT02721108; ISRCTN10925965; Results.

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<![CDATA[B!RTH: a mixed-methods survey of audience members’ reflections of a global women’s health arts and science programme in England, Ireland, Scotland and Switzerland]]> https://www.researchpad.co/product?articleinfo=N81fa4bb1-b4ec-403f-84d1-f10e8c5992ba

Objective

Public engagement and science communication are growing as an important forum in the design and dissemination of research. The B!RTH programme is a partnership that uses theatre in combination with scientific expert panel discussions to raise awareness about the global inequality in women’s health and access to healthcare. As part of this project, we assessed the views and experiences of audiences participating in B!RTH events.

Design

We conducted a multi-site mixed-methods survey using paper-based questionnaires.

Settings

Data were collected at four B!RTH theatre and science events: Dublin (Ireland), Edinburgh (Scotland), Geneva (Switzerland) and Liverpool (England) after the performance of four plays and three expert panel discussions.

Participants

All audience members.

Methods

Descriptive analysis was conducted for the responses to the closed-ended survey questions, and thematic analysis was used for written free text provided.

Results

The estimated response rate was 42%; 363 members of the audiences responded. Most respondents had been emotionally moved by the performances (92.8%) and felt challenged and provoked (80.7%). Many respondents (73.6%) agreed that their eyes had been opened by new ideas. Five themes emerged from the free-text analysis: (1) an expression of thanks and positive feedback on the content and performance of the plays, (2) the benefit of and innovative use of art and science, (3) personal feelings in response to the plays and panel discussions, (4) the need for action and (5) suggestions for use of the plays and panel discussions in schools and universities to ‘bring to life the human story behind the statistics’.

Conclusions

The B!RTH programme highlights how art and science can be used in partnership and is an effective tool to engage the public, to deliver key messages and to raise awareness about inequalities in global maternal and reproductive healthcare issues.

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<![CDATA[Efficacy of adjunctive azithromycin versus single-dose cephalosporin prophylaxis for caesarean scar defect: study protocol for a randomised controlled trial]]> https://www.researchpad.co/product?articleinfo=Nc1cd4aba-83aa-4495-be26-29e2aa72554d

Introduction

Perioperative infections may be considered predictors of caesarean scar defect (CSD), and multidose antibiotics have a protective effect against CSD. However, the ability of adjunctive azithromycin combined with cephalosporin to reduce the prevalence of CSD remains unclear. The planned study aims to clarify the protective effect of antibiotics against CSD and to assess the effectiveness of adjunctive azithromycin prophylaxis for CSD.

Methods and analysis

This study is a double-blind, parallel-control randomised clinical trial that will be carried out at the International Peace Maternity and Child Health Hospital. A total of 220 eligible patients will be randomised (1:1) to receive either adjunctive azithromycin or single-dose cephalosporin 30 min before the incision. The evaluation criteria are the prevalence and characteristics of CSD as assessed by transvaginal ultrasound (TVU) and saline infusion sonohysterography (SIS) at 42 days, 6 months and 12 months after delivery. The primary outcome will be the prevalence of CSD, and the characteristics of CSD will be assessed by TVU and SIS 42 days after delivery; all other outcomes are secondary.

Ethics and dissemination

This protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 25 April 2018 (approval no. GKLW2017-84). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings.

Trial registration number

ChiCTR-INR-17013272.

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<![CDATA[Pre-post implementation survey of a multicomponent intervention to improve informed consent for caesarean section in Southern Malawi]]> https://www.researchpad.co/product?articleinfo=Na1c7cf2d-1300-427f-b5ab-d98854df09e3

Objective

Surgical informed consent is essential prior to caesarean section, but potentially compromised by insufficient communication. We assessed the association between a multicomponent intervention and women’s recollection of information pertaining to informed consent for caesarean section in a low-resource setting, thereby contributing to respectful maternity care.

Design

Pre-post implementation survey, conducted from January to June 2018, surveying women prior to discharge.

Setting

Rural 150-bed mission hospital in Southern Malawi.

Participants

A total of 160 postoperative women were included: 80 preimplementation and 80 postimplementation.

Intervention

Based on observed deficiencies and input from local stakeholders, a multicomponent intervention was developed, consisting of a standardised checklist, wall poster with a six-step guide and on-the-job communication training for health workers.

Primary and secondary outcome measures

Individual components of informed consent were: indication, explanation of procedure, common complications, implications for future pregnancies and verbal enquiry of consent, which were compared preintervention and postintervention using χ2 test. Generalised linear models were used to analyse incompleteness scores and recollection of the informed consent process.

Results

The proportion of women who recollected being informed about procedure-related risks increased from 25/80 to 47/80 (OR 3.13 (95% CI 1.64 to 6.00)). Recollection of an explanation of the procedure changed from 44/80 to 55/80 (OR 1.80 (0.94 to 3.44)), implications for future pregnancy from 25/80 to 47/80 (1.69 (0.89 to 3.20)) and of consent enquiry from 67/80 to 73/80 (OR 2.02 (0.73 to 5.37)). After controlling for other variables, incompleteness scores postintervention were 26% lower (Exp(β)=0.74; 95% CI 0.57 to 0.96). Recollection of common complications increased with 0.25 complications (β=0.25; 95% CI 0.01 to 0.49). Recollection of the correct indication did not differ significantly.

Conclusion

Recollection of informed consent for caesarean section changed significantly in the postintervention group. Obtaining informed consent for caesarean section is one of the essential components of respectful maternity care.

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<![CDATA[Women’s satisfaction with midwife-led continuity of care: an observational study in Palestine]]> https://www.researchpad.co/product?articleinfo=N4829ea7b-9d5c-4ceb-a769-6b189e13223f

Objectives

A midwife-led continuity model of care had been implemented in the Palestinian governmental health system to improve maternal services in several rural areas. This study investigated if the model influenced women’s satisfaction with care, during antenatal, intrapartum and postnatal period.

Design

An observational case-control design was used to compare the midwife-led continuity model of care with regular maternity care.

Participants and setting

Women with singleton pregnancies, who had registered for antenatal care at a rural governmental clinic in the West Bank, were between 1 to 6 months after birth invited to answer a questionnaire rating satisfaction with care in 7-point Likert scales.

Primary outcome

The mean sum-score of satisfaction with care through the continuum of antenatal, intrapartum and postnatal period, where mean sum-scores range from 1 (lowest) to 7 (highest).

Secondary outcome

Exclusive breastfeeding.

Results

Two hundred women answered the questionnaire, 100 who received the midwife-led model and 100 who received regular care. The median time point of interview were 16 weeks postpartum in both groups. The midwife-led model was associated with a statistically significant higher satisfaction with care during antenatal, intrapartum and postnatal period, with a mean sum-score of 5.2 versus 4.8 in the group receiving regular care. The adjusted mean difference between the groups’ sum-score of satisfaction with care was 0.6 (95% CI 0.35 to 0.85), p<0.0001. A statistically significant higher proportion of women who received the midwife-led continuity model of care were still exclusively breastfeeding at the time point of interview, 67% versus 46% in the group receiving regular care, an adjusted OR of 2.56 (1.35 to 4.88) p=0.004.

Conclusions

There is an association between receiving midwife-led continuity of care and increased satisfaction with care through the continuum of pregnancy, intrapartum and postpartum period, and an increased duration of exclusive breastfeeding.

Trial registration number

NCT03863600

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<![CDATA[Serum hepcidin and iron status parameters in pregnant women and the association with adverse maternal and fetal outcomes: a study protocol for a prospective cohort study]]> https://www.researchpad.co/product?articleinfo=Na7e6f570-f91d-4dd4-81ff-ae64a975ddf6

Introduction

Hepcidin production is normally upregulated by iron stores, and in obesity has been shown to be overexpressed and correlated with low iron status. The increased hepcidin may restrain the iron release from the cells by affecting the expression of ferroportin, which probably associates with the development of diabetes complication. First, we investigate the difference of serum hepcidin and iron parameters between obese and non-obese pregnant women; second, we examine the correlation between serum hepcidin and adverse maternal and neonatal outcomes in pregnant women.

Methods and analysis

This is a mono-centre, prospective cohort study with a study (obese) and a control group (non-obese women). In the first trimester, 188 singleton pregnancies will be recruited. Thereof, we expect 75 with a body mass index (BMI) ≥30 kg/m2 and 113 with a BMI 18.5–30 kg/m2. Serum hepcidin, iron and haematological parameters will be measured at 11–14, 24–28, 32–36 weeks of gestation and at time of delivery. Blood pressure, weight, BMI and smoking status will be examined at all visits. We will assess the composite endpoints adverse maternal outcomes (including pre-eclampsia, gestational hypertension, gestational diabetes mellitus, haemorrhage, placenta abruption) and adverse neonatal outcomes (preterm birth, intrauterine growth restriction, preterm premature rupture of membranes, Apgar score <7 at 5 min, stillbirth, neonatal death).

Recruitment has started in April 2019.

Ethics and dissemination

This study received ethical approval from the ethics committee in Basel. The results of the study will be published in a peer-reviewed journal, and presented at national scientific conferences.

Trial registration number

NCT03792464.

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<![CDATA[Intermittent fetal heart rate monitoring using a fetoscope or hand held Doppler in rural Tanzania: a randomized controlled trial]]> https://www.researchpad.co/product?articleinfo=5b5977d9463d7e5ce270da28

Background

Neonatal mortality is a global challenge, with an estimated 1.3 million intrapartum stillbirths in 2015. The majority of these were found in low resource settings with limited options to intrapartum fetal heart monitoring devices. This trial compared frequency of abnormal fetal heart rate (FHR) detection and adverse perinatal outcomes (i.e. fresh stillbirths, 24-h neonatal deaths, admission to neonatal care unit) among women intermittently assessed by Doppler or fetoscope in a rural low-resource setting.

Methods

This was an open-label randomized controlled trial conducted at Haydom Lutheran Hospital from March 2013 through August 2015. Inclusion criteria were; women in labor, singleton, cephalic presentation, normal FHR on admission (120–160 beats/minute), and cervical dilatation ≤7 cm. Verbal consent was obtained.

Results

A total of 2684 women were recruited, 1309 in the Doppler and 1375 in the fetoscope arms, respectively. Abnormal FHR was detected in 55 (4.2%) vs 42 (3.1%). (RR = 1.38; 95%CI: 0.93, 2.04) in the Doppler and fetoscope arms, respectively. Bag mask ventilation was performed in 80 (6.1%) vs 82 (6.0%). (RR = 1.03; 95%CI: 0.76, 1.38) of neonates, and adverse perinatal outcome was comparable 32(2.4%) vs 35(2.5%). (RR = 0.9; 95%CI: 0.59, 1.54), in the Doppler and fetoscope arms, respectively.

Conclusion

This trial failed to demonstrate a statistically significant difference in the detection of abnormal FHR between intermittently used Doppler and fetoscope and adverse perinatal outcomes. However, FHR measurements were not performed as often as recommended by international guidelines. Conducting a randomized controlled study in rural settings with limited resources is associated with major challenges.

Trial registration

This clinical trial was registered on April 2013 with registration number NCT01869582.

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<![CDATA[Ovarian reserve evaluation after laparoscopic cyst enucleation, depending on applied haemostasis technique and with particular consideration of endometrial cysts]]> https://www.researchpad.co/product?articleinfo=5b592bc9463d7e57a32e3e53

Aim of the study

was an evaluation of the effects, exerted by obtained haemostasis on ovarian reserve, depending on haemostasis technique, applied after laparoscopic enucleation of endometrial cysts.

Material and methods

Sixty-six female patients, at the age of 20-35 years, were included into the study. The diameters of the cystic lesions were within 40-70 mm. The patients were randomly assigned to two study groups. Group 1 involved patients after laparoscopic enucleation of ovarian cysts, in whom haemostasis was achieved by ovary suturing, while Group 2 included patients with haemostasis achieved by bipolar coagulation technique. Cyst enucleation was performed in all the patients by the stripping method. Ovarian reserve markers: AFC (antral follicle count), AMH (anti-Müllerian hormone), and inhibin B were assayed before and three months after the surgery.

Results

The preoperative values of AMH, AFC, and inhibin B were similar in both studied groups. After a three-month follow up, the post-operative levels of AMH and inhibin B were significantly lower (p < 0.05), while the numbers of antral follicles did not reveal any statistical differences (p > 0.05). While comparing endometrial and dermoid cysts in the sutured group of patients, the difference, regarding AMH, was statistically significant (2.13 vs. 4.69, p = 0.03). In the group of patients after bipolar coagulation, the corresponding differences did not attain statistical significance (2.21 vs. 6.51, p = 0.86)

Conclusions

Comparing pre- and post-operative levels of AMH and inhibin B, regardless of the applied haemostasis technique, a statistically significant reduction of the ovarian reserve was observed in either group. Comparing both haemostasis techniques, no method was demonstrated that would have decreased less the levels of AMH, AFC, or inhibin B.

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<![CDATA[Absolute income is a better predictor of coverage by skilled birth attendance than relative wealth quintiles in a multicountry analysis: comparison of 100 low- and middle-income countries]]> https://www.researchpad.co/product?articleinfo=5b58c12a463d7e503db4cf35

Background

Having high-quality data available by 2020, disaggregated by income, is one of the Sustainable Development Goals (SGD). We explored how well coverage with skilled birth attendance (SBA) is predicted by asset-based wealth quintiles and by absolute income.

Methods

We used data from 293 national surveys conducted in 100 low and middle-income countries (LMICs) from 1991 to 2014. Data on household income were computed using national income levels and income inequality data available from the World Bank and the Standardized World Income Inequality Database. Multivariate regression was used to explore the predictive capacity of absolute income compared to the traditional measure of quintiles of wealth index.

Results

The mean SBA coverage was 68.9% (SD: 24.2), compared to 64.7% (SD: 26.6) for institutional delivery coverage. Median daily family income in the same period was US$ 6.4 (IQR: 3.5–14.0). In cross-country analyses, log absolute income predicts 51.5% of the variability in SBA coverage compared to 22.0% predicted by the wealth index. For within-country analysis, use of absolute income improved the understanding of the gap in SBA coverage among the richest and poorest families. Information on income allowed identification of countries – such as Burkina Faso, Cambodia, Egypt, Nepal and Rwanda – which were well above what would be expected solely from changes in income.

Conclusion

Absolute income is a better predictor of SBA and institutional delivery coverage than the relative measure of quintiles of wealth index and may help identify countries where increased coverage is likely due to interventions other than increased income.

Electronic supplementary material

The online version of this article (10.1186/s12884-018-1734-0) contains supplementary material, which is available to authorized users.

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<![CDATA[Barriers to and strategies for addressing the availability, accessibility, acceptability and quality of the sexual, reproductive, maternal, newborn and adolescent health workforce: addressing the post-2015 agenda]]> https://www.researchpad.co/product?articleinfo=5b4b23fc463d7e737c241d54

Background

In a post-2015 development agenda, achieving Universal Health Coverage (UHC) for women and newborns will require a fit-for-purpose and fit-to-practice sexual, reproductive, maternal, adolescent and newborn health (SRMNAH) workforce. The aim of this paper is to explore barriers, challenges and solutions to the availability, accessibility, acceptability and quality (AAAQ) of SRMNAH services and workforce.

Methods

The State of the World’s Midwifery report 2014 used a broad definition of midwifery (“the health services and health workforce needed to support and care for women and newborns”) and provided information about a wide range of SRMNAH workers, including doctors, midwives, nurses and auxiliaries. As part of the data collection, 36 out of the 73 participating low- and middle-income countries conducted a one-day workshop, involving a range of different stakeholders. Participants were asked to discuss barriers to the AAAQ of SRMNAH workers, and to suggest strategies for overcoming the identified barriers. The workshop was facilitated using a discussion guide, and a rapporteur took detailed notes. A content analysis was undertaken using N-Vivo software and the AAAQ model as a framework.

Results

Across the 36 countries, about 800 participants attended a workshop. The identified barriers to AAAQ of SRMNAH workers included: insufficient size of the workforce and inequity in its distribution, lack of transportation, user fees and out of pocket payments. In some countries, respondents felt that women mistrusted the workforce, and particularly midwives, due to cultural differences, or disrespectful behaviour towards service users. Quality of care was undermined by a lack of supplies/equipment and inadequate regulation. Against these, countries identified a set of solutions including adequate workforce planning supported by a fast and equitable deployment system, aligned with the principles of UHC. Acceptability and quality could be improved with the provision of respectful care as well as strategies to improve education and regulation.

Conclusions

The number and scale of the barriers still needing to be addressed in these 36 countries was significant. Adequate planning and policies to support the development of the SRMNAH workforce and its equitable distribution are a priority. Enabling strategies need to be put in place to improve the status and recognition of midwives, whose role is often undervalued.

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<![CDATA[A randomized controlled trial of an intervention delivered by mobile phone app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan]]> https://www.researchpad.co/product?articleinfo=5b4aea66463d7e6db07a9e1c

Background

Unintended pregnancy is associated with poorer health outcomes for women and their families. In Tajikistan, around 26% of married 15–24 year old women have an unmet need for contraception. There is some evidence that interventions delivered by mobile phone can affect contraceptive-related behaviour and knowledge. We developed an intervention delivered by mobile phone app instant messaging to improve acceptability of effective contraceptive methods among young people in Tajikistan.

Methods

This was a randomized controlled trial among Tajik people aged 16–24. Participants allocated to the intervention arm had access to an app plus intervention messages. Participants allocated to the control arm had access to the app plus control messages. The primary outcome was acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception at 4 months and during the study, acceptability of individual methods, service uptake, unintended pregnancy and induced abortion. Process outcomes were knowledge, perceived norms, personal agency and intention. Outcomes were analysed using logistic and linear regression. We conducted a pre-specified subgroup analysis and a post-hoc analysis of change in acceptability from baseline to follow-up.

Results

Five hundred and seventy-three participants were enrolled. Intervention content was included on the app, causing contamination. Four hundred and seventy-two (82%) completed follow-up for the primary outcome. There was no evidence of a difference in acceptability of effective contraception between the groups (66% in the intervention arm vs 64% in the control arm, adjusted OR 1.21, 95% CI .80–1.83, p = 0.36). There were no differences in the secondary or process outcomes between groups. There was some evidence that the effect of the intervention was greater among women compared to men (interaction test p = 0.03). There was an increase in acceptability of effective contraception from baseline to follow-up (2% to 65%, p < 0.001).

Conclusions

The whole intervention delivered by instant messaging provided no additional benefit over a portion of the intervention delivered by app pages. The important increase in contraceptive acceptability from baseline to follow-up suggests that the intervention content included on the app may influence attitudes. Further research is needed to establish the effect of the intervention on attitudes towards and use of effective contraception among married/sexually active young people.

Trial registration

Clinicaltrial.gov NCT02905513. Date of registration: 14 September 2016.

Electronic supplementary material

The online version of this article (10.1186/s12978-018-0473-z) contains supplementary material, which is available to authorized users.

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