scholarly journals Women´s expectations and experiences of labour induction—a questionnaire-based analysis of a randomised controlled trial

2019 ◽  
Author(s):  
Moa Strandberg ◽  
Tove Wallström ◽  
Eva Wiberg-Itzel
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Labour Induction ◽  
Background Characteristics ◽  
Fear Of Childbirth ◽  
Negative Experience ◽  
Obstetrical Care ◽  
Increased Risk ◽  
Randomised Controlled ◽  
To Receive

Abstract Background: Although the induction of labour is a commonly used procedure in obstetrical care, there are limited data on its psycho-emotional effects on the woman. This study analysed the expectations and experiences of women included in a randomised controlled trial comparing different routes of labour induction. The primary aim of this questionnaire-based study was to evaluate women’s general satisfaction with induced labours and identify factors associated with a negative experience. The secondary aim was to compare the orally administrated misoprostol (OMS) to a misoprostol vaginal insert (MVI), while focusing on general maternal satisfaction. Methods Primiparous women (n = 196) with a singleton foetus in cephalic presentation, ≥ 37 weeks of gestation, with a Bishop´s score ≤ 4 planning labour induction were randomly allocated to receive either OMS (Cytotec®) or MVI (Misodel®). Data were collected by validated questionnaires, the Wijma Delivery Expectation/Experience Questionnaire (A+B). The pre-labour part of the questionnaire (W-DEQ version A) was given to participants to complete within one hour before the start of induction, and the post-labour part of the questionnaire (W-DEQ version B) was administered after birth and collected before the women were discharged from hospital. Background characteristics and delivery outcomes were extracted from maternity files and correlated to the results from the questionnaires. Results The mean score of the post-labour questionnaire (W-DEQ B) was 61.2 (22.9) and OMS and MVI generated comparable experiences among the participating women with a W-DEQ B score of 59.4 (21.0) and 62.7 (24.7), respectively (p = 0.48). It was found that 11.8% (17/143) reported a severe fear of childbirth (W-DEQ A score ≥ 85). Women that stated a severe fear before the start of induction had a 3.7 times increased risk of experiencing labour induction negatively (OR 3.7 [95% CI; 1.04–13.41]). Conclusion Severe fear of childbirth was a risk factor for a negative experience of labour induction. OMS compared to MVI generated comparable results among participating women in this randomised controlled trial.

scholarly journals Effects of injectable progestogen contraception versus the copper intrauterine device on HIV acquisition: sub-study of a pragmatic randomised controlled trial

2017 ◽  
Vol 43 (3) ◽  
pp. 175-180 ◽  
Author(s):  
G Justus Hofmeyr ◽  
Mandisa Singata-Madliki ◽  
Theresa A Lawrie ◽  
Eduardo Bergel ◽  
Marleen Temmerman
Keyword(s):  
Randomised Controlled Trial ◽  
South African ◽  
Pregnancy Termination ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Randomised Trial ◽  
Contraceptive Device ◽  
Increased Risk ◽  
Hiv Acquisition ◽  
Randomised Controlled

BackgroundEvidence from observational studies suggests an increased risk of HIV acquisition among women using depot medroxyprogesterone acetate (DMPA) contraception.MethodsWithin the context of a South African programme to increase women's access to the intrauterine contraceptive device (IUD), we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial (RCT) of the IUD versus injectable progestogen contraception (IPC) at two South African hospitals. The primary outcome was pregnancy; secondary outcomes included HIV acquisition. Consenting women attending termination of pregnancy services were randomised after pregnancy termination between July 2009 and November 2012. Condoms were promoted for the prevention of sexually transmitted infections. Voluntary HIV testing was offered at baseline and at 12 or more months later. Findings on HIV acquisition are reported in this article.ResultsHIV acquisition data were available for 1290 initially HIV-negative women who underwent a final study interview at a median of 20 months after randomisation to IPC or an IUD. Baseline group characteristics were comparable. In the IPC group, 545/656 (83%) of participants received DMPA, 96 (15%) received injectable norethisterone enanthate, 14 (2%) received the IUD and one received oral contraception. In the IUD group 609 (96%) received the IUD, 20 (3%) received IPC and 5 (1%) had missing data. According to intention-to-treat analysis, HIV acquisition occurred in 20/656 (3.0%) women in the IPC arm and 22/634 (3.5%) women in the IUD arm (IPC vs IUD, risk ratio 0.88; 95% confidence interval 0.48–1.59;p=0.7).ConclusionsThis sub-study was underpowered to rule out moderate differences in HIV risk, but confirms the feasibility of randomised trial methodology to address this question. Larger RCTs are needed to determine the relative risks of various contraceptive methods on HIV acquisition with greater precision.Trial registration numberPan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).

DHA supplementation in infants born preterm and the effect on attention at 18 months’ corrected age: follow-up of a subset of the N3RO randomised controlled trial

2020 ◽  
pp. 1-12 ◽  
Author(s):  
Erandi Hewawasam ◽  
Carmel T. Collins ◽  
Beverly S. Muhlhausler ◽  
Lisa N. Yelland ◽  
Lisa G. Smithers ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
High Dose ◽  
Peak Period ◽  
Soya Oil ◽  
Randomised Controlled ◽  
To Receive ◽  
The Brain

Abstract Infants born preterm miss out on the peak period of in utero DHA accretion to the brain during the last trimester of pregnancy which is hypothesised to contribute to the increased prevalence of neurodevelopmental deficits in this population. This study aimed to determine whether DHA supplementation in infants born preterm improves attention at 18 months’ corrected age. This is a follow-up of a subset of infants who participated in the N3RO randomised controlled trial. Infants were randomised to receive an enteral emulsion of high-dose DHA (60 mg/kg per d) or no DHA (soya oil – control) from within the first days of birth until 36 weeks’ post-menstrual age. The assessment of attention involved three tasks requiring the child to maintain attention on toy/s in either the presence or absence of competition or a distractor. The primary outcome was the child’s latency of distractibility when attention was focused on a toy. The primary outcome was available for seventy-three of the 120 infants that were eligible to participate. There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0·08 s, 95 % CI –0·81, 0·97; P = 0·86). Enteral DHA supplementation did not result in improved attention in infants born preterm at 18 months’ corrected age.

Patient experience of preheated and room temperature skin disinfection prior to cardiac device implantation: A randomised controlled trial

2020 ◽  
Vol 19 (6) ◽  
pp. 529-536
Author(s):  
Camilla Wistrand ◽  
Ulrica Nilsson ◽  
Ann-Sofie Sundqvist
Keyword(s):  
Randomised Controlled Trial ◽  
Patient Experience ◽  
Room Temperature ◽  
Controlled Trial ◽  
Cardiac Device ◽  
Negative Experience ◽  
Device Implantation ◽  
Skin Disinfection ◽  
Registration Number ◽  
Randomised Controlled

Background: Clinically, patients often comment on the coolness of the skin disinfectant. However, scarce evidence is available regarding patients’ experience during intraoperative skin disinfection. Aims: The aim of this study was to describe and compare intraoperative patient experiences with preheated and room temperature skin disinfectant. Method: This randomised controlled trial included 220 patients undergoing cardiac device implantation. Patients allocated to preheated (36°C) or room temperature (20°C) chlorhexidine in 70% ethanol verbally answered an open-ended question regarding their experience with the skin disinfection. Results were assessed using a qualitative approach with comparative quantification. Results: The analysis resulted in nine categories describing the patients’ experiences with preheated and room temperature skin disinfection. Most of the patients described the skin disinfection process as a negative experience, which consisted of six categories: cold, smell, change in temperature, unpleasant, wet and painful. In addition, two neutral categories of response (nothing in particular and neither pleasant nor unpleasant) and one positive response (pleasant) emerged through the analysis. Preheated skin disinfection yielded significantly fewer negative experiences in the category cold (85% vs. 15%, P<0.0001) and significantly more positive experiences (66% vs. 34%, P<0.002). Neutral categories (neither pleasant nor unpleasant 65% vs. 35%, P=0.01, nothing in particular 74% vs. 26%, P<0.001) dominated after preheated skin disinfection. Conclusion: The use of preheated skin disinfection promotes a positive patient experience with skin disinfection. Trial registration: ClinicalTrials.gov registration number NCT02260479 ( https://clinicaltrials.gov/ct2/results?cond=preheated+skin+disinfection ).

scholarly journals Suboxone Treatment and Recovery Trial (STAR-T): Study Protocol for a Randomised Controlled Trial of Opioid Medication Assisted Treatment with Adjunctive Medication Management Using Therapeutic Drug Monitoring and Contingency Management

2019 ◽  
Vol 2019 ◽  
pp. 1-11
Author(s):  
Hesham Elarabi ◽  
Abuelgasim Elrasheed ◽  
Ahmed Ali ◽  
Mansour Shawky ◽  
Nael Hasan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Therapeutic Drug Monitoring ◽  
Controlled Trial ◽  
Contingency Management ◽  
Medication Management ◽  
Therapeutic Drug ◽  
Opioid Medication ◽  
Management Framework ◽  
Randomised Controlled ◽  
To Receive

Introduction. Opioid assisted treatment (OAT) with buprenorphine (BUP) is front-line medical maintenance intervention for illicit and prescription opioid use disorder (OUD). In many clinics, opioid medication is dispensed for several days for self-administration. This provides flexibility to the patient but may compromise the effectiveness of OAT because of nonadherence or medication diversion. OAT can be delivered as an entirely supervised intervention, but many patients discontinue treatment under this arrangement and dispensing costs may be prohibitive. An alternative is to enable patients to receive take-home doses contingent on OAT adherence guided by a medication management framework using Therapeutic Drug Monitoring (TDM) alongside negative urine drug screens (UDS) to provide evidence of abstinence. TDM is recommended to monitor adherence with BUP but it has not been applied in OAT programs and evaluation research to date. Methods. The Suboxone Treatment and Recovery Trial (STAR-T) is a single site, 16-week, parallel-group, randomised controlled trial. The aim of the study is to determine the effectiveness of a medication management framework including TDM and UDS to enable patients enrolled on outpatient OAT (with buprenorphine/naloxone [sublingual film formulation; BUP/NX-F; Suboxone™]) to receive stepped take-home doses. Following stabilisation during inpatient care, adult participants with illicit or prescription OUD were allocated (1:1) to receive (1) BUP/NX-F plus medication management for take-home doses based on TDM, UDS, and contingency management protocol (the experimental group) or (2) BUP/NX-F plus UDS only (treatment-as-usual, the control group). The primary outcome is the mean percentage of negative UDS over 16 weeks. The secondary outcome is treatment retention defined as completion of 16 weeks of OAT without interruption. There will be an exploratory analysis of the association between participant characteristics, clinical data, and outcomes. Conclusions. Providing BUP/NX-F take-home doses contingent on adherence and opioid abstinence may enable OAT to be delivered flexibly and effectively. Trial Registration. ISRCTN41645723 is retrospectively registered on 15/11/2015.

scholarly journals Healthy Parent Carers peer-led group-based health promotion intervention for parent carers of disabled children: protocol for a feasibility study using a parallel group randomised controlled trial design

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Gretchen Bjornstad ◽  
Kath Wilkinson ◽  
Beth Cuffe-Fuller ◽  
Katharine Fitzpatrick ◽  
Aleksandra Borek ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Trial Design ◽  
Controlled Trial ◽  
Well Being ◽  
Online Resources ◽  
Disabled Children ◽  
Link Type ◽  
Increased Risk ◽  
Randomised Controlled

Abstract Background Parent carers of disabled children are at increased risk of mental and physical health problems. They often experience challenges to maintaining good health which have implications for their well-being and their ability to care for their children. In response to these needs, researchers and parent carers developed the Healthy Parent Carers (HPC) programme. It is a peer-led, group-based intervention that promotes behaviours associated with health and well-being. The aims of this trial are to assess the acceptability of the HPC programme and the feasibility of its delivery in the community and to assess the feasibility and acceptability of the design of the definitive trial to evaluate the programme’s effectiveness and cost-effectiveness. Methods We will establish six research sites and train facilitators to deliver the manualised intervention. Parent carers of children with special educational needs and disabilities will be individually randomised, stratified by group delivery site, to either take part in a group programme and online resources (intervention) or to receive access to the online resources only (control). Measures of mental health; well-being; health-related quality of life; health behaviours; patient activation; protective factors such as resilience, social connections, and practical support; and use of health care, social care, and wider societal resources will be collected before randomisation (baseline), immediately post-intervention, and 6 months later. Recruitment of participants, adherence to the programme, and the dose received will be assessed. Group sessions will be audio-recorded to evaluate the fidelity of delivery and participant engagement. Participants’ and facilitators’ feedback on the programme content and delivery, their experience, and the acceptability of the outcome measures and trial design will be collected through feedback forms, interviews, and focus groups. Discussion This trial will assess whether the programme delivery and evaluative trial design are feasible, to inform whether to progress to a definitive randomised controlled trial to test the effectiveness and cost-effectiveness of the Healthy Parent Carers programme. Trial registration ISRCTN, ISRCTN151144652, registered on 25 October 2018; ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

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