Sublingual Misoprostol versus Intramuscular Oxytocin for Prevention of Postpartum Hemorrhage in Uganda: A Double-Blind Randomized Non-Inferiority Trial

Atukunda, Esther C; Siedner, Mark J.; Obua, Celestino; Mugyenyi, Godfrey R; Twagirumukiza, Marc; Agaba, Amon Ganafa

doi:10.1371/journal.pmed.1001752

Cited by 31 publications

(34 citation statements)

References 31 publications

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“…Less hemoglobin drop among misoprostol group in our results was similar to the results of Bellad et al (10), but different from those of Atukunda et al and Rajaei et al (11,17). In these 2 studies, hemoglobin drop was not significantly different between their study groups.…”

Section: Discussionsupporting

confidence: 59%

Umbilical Vein Injection of Misoprostol Versus Oxytocin for Managing Retained Placenta After Parturition: A Randomized Clinical Trial

Najafian¹,

Ghasemi²,

Hajiha-Esfahani³

2017

International Journal of Women’s Health and Reproduction Scienc

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Parturition process consists of three stages: 1) from parturition pain onset to complete cervical dilatation; 2) from complete cervical dilatation to child delivery; and 3) from complete fetus delivery to placental delivery. Retained placenta means that the placenta is remained in the mother's uterine for a certain period after fetus delivery. This period is reported to be between 30-60 minutes in different countries (1,2). The prevalence of retained placenta is different between various countries and it has been 0.01% to 6.3% in different studies (3). Parturition is a prevalent complication caused by a long third stage bleeding. It is a common cause of death in the developing and even developed countries (4). Risk factors for the retained placenta can be gestational age (especially less than 26 weeks), preeclampsia, abortion history, old age, high polarity, use of parturition medicines such as oxytocin, being of non-Asian race and also other factors such as small placenta, too much bleeding and vaginal damage history (5). Furthermore, studies have revealed that taking intra-vein ergometrine can be a risk factor for the retained placenta (5-7). Likewise, taking methyl ergometrine rather than oxytocin is more associated with retained placenta (8). Many treatments have been proposed for the retained placenta, however, there are a few reports on using prostaglandins and umbilical vein injection of oxytocin (9). Moreover, different administration methods of oxytocin and misoprostol (oral, vaginal, or intravenous injection) have had different results (10,11). We undertook this investigation because this treatment can prevent dangerous consequences for a mother's life. Few studies have compared the effects of umbilical vein injection of oxytocin and misoprostol. Therefore, this study compared the umbilical vein injection of misoprostol and oxytocin to manage retained placenta in the women who had referred to Moheb-Yass and Shariati hospitals in Tehran and Bandar Abbas cities, Iran. Materials and Methods This randomized clinical trial was done on 44 women suffering from a long third stage parturition (retained placenta after 30 minutes) who had referred to the hospital between 2012 and 2015. They were randomly divided into 2 groups: oxytocin and misoprostol groups. The inclusion criteria were: 1) successful first and second parturition stages and 2) having a retained placenta 30 minutes after fetus delivery. The exclusion criteria were: 1) instability

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Section: Discussionsupporting

confidence: 59%

Umbilical Vein Injection of Misoprostol Versus Oxytocin for Managing Retained Placenta After Parturition: A Randomized Clinical Trial

Najafian¹,

Ghasemi²,

Hajiha-Esfahani³

2017

International Journal of Women’s Health and Reproduction Scienc

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“…Among the 17 studies 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 providing sufficient data for reanalysis of their primary outcomes, 14 (82%, 95% confidence interval 59% to 94%) studies were fully reproduced on all their primary outcomes. One of the 17 studies did not provide enough information in the Methods section for the analyses to be reproduced (specifically, the methods used for adjustment were unclear).…”

Section: Resultsmentioning

confidence: 99%

Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published inThe BMJandPLOS Medicine

Naudet

Sakarovitch

Janiaud

et al. 2018

BMJ

180

171

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ObjectivesTo explore the effectiveness of data sharing by randomized controlled trials (RCTs) in journals with a full data sharing policy and to describe potential difficulties encountered in the process of performing reanalyses of the primary outcomes.DesignSurvey of published RCTs.SettingPubMed/Medline.Eligibility criteriaRCTs that had been submitted and published by The BMJ and PLOS Medicine subsequent to the adoption of data sharing policies by these journals.Main outcome measureThe primary outcome was data availability, defined as the eventual receipt of complete data with clear labelling. Primary outcomes were reanalyzed to assess to what extent studies were reproduced. Difficulties encountered were described.Results37 RCTs (21 from The BMJ and 16 from PLOS Medicine) published between 2013 and 2016 met the eligibility criteria. 17/37 (46%, 95% confidence interval 30% to 62%) satisfied the definition of data availability and 14 of the 17 (82%, 59% to 94%) were fully reproduced on all their primary outcomes. Of the remaining RCTs, errors were identified in two but reached similar conclusions and one paper did not provide enough information in the Methods section to reproduce the analyses. Difficulties identified included problems in contacting corresponding authors and lack of resources on their behalf in preparing the datasets. In addition, there was a range of different data sharing practices across study groups.ConclusionsData availability was not optimal in two journals with a strong policy for data sharing. When investigators shared data, most reanalyses largely reproduced the original results. Data sharing practices need to become more widespread and streamlined to allow meaningful reanalyses and reuse of data.Trial registrationOpen Science Framework osf.io/c4zke.

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“…Full study procedures have been described previously[ 19 ]. Trained midwife research assistants (MRAs) screened labouring mothers in early active labour on arrival to the prenatal ward.…”

Section: Methodsmentioning

confidence: 99%

Measuring Post-Partum Haemorrhage in Low-Resource Settings: The Diagnostic Validity of Weighed Blood Loss versus Quantitative Changes in Hemoglobin

et al. 2016

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BackgroundAccurate estimation of blood loss is central to prompt diagnosis and management of post-partum hemorrhage (PPH), which remains a leading cause of maternal mortality in low-resource countries. In such settings, blood loss is often estimated visually and subjectively by attending health workers, due to inconsistent availability of laboratory infrastructure. We evaluated the diagnostic accuracy of weighed blood loss (WBL) versus changes in peri-partum hemoglobin to detect PPH.MethodsData from this analysis were collected as part of a randomized controlled trial comparing oxytocin with misoprostol for PPH (NCT01866241). Blood samples for complete blood count were drawn on admission and again prior to hospital discharge or before blood transfusion. During delivery, women were placed on drapes and had pre-weighed sanitary towels placed around their perineum. Blood was then drained into a calibrated container and the sanitary towels were added to estimate WBL, where each gram of blood was estimated as a milliliter. Sensitivity, specificity, negative and positive predictive values (PPVs) were calculated at various blood volume loss and time combinations, and we fit receiver-operator curves using blood loss at 1, 2, and 24 hours compared to a reference standard of haemoglobin decrease of >10%.ResultsA total of 1,140 women were enrolled in the study, of whom 258 (22.6%) developed PPH, defined as a haemoglobin drop >10%, and 262 (23.0%) had WBL ≥500mL. WBL generally had a poor sensitivity for detection of PPH (<75% for most volume-time combinations). In contrast, the specificity of WBL was high with blood loss ≥ 500mL at 1h and ≥750mL at any time points excluding PPH in over 97% of women. As such, WBL has a high PPV (>85%) in high prevalence settings when WBL exceeds 750mL.ConclusionWBL has poor sensitivity but high specificity compared to laboratory-based methods of PPH diagnosis. These characteristics correspond to a high PPV in areas with high PPH prevalence. Although WBL is not useful for excluding PPH, this low-cost, simple and reproducible method is promising as a reasonable method to identify significant PPH in such settings where quantifiable red cell indices are unavailable.

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Sublingual Misoprostol versus Intramuscular Oxytocin for Prevention of Postpartum Hemorrhage in Uganda: A Double-Blind Randomized Non-Inferiority Trial

Cited by 31 publications

References 31 publications

Umbilical Vein Injection of Misoprostol Versus Oxytocin for Managing Retained Placenta After Parturition: A Randomized Clinical Trial

Umbilical Vein Injection of Misoprostol Versus Oxytocin for Managing Retained Placenta After Parturition: A Randomized Clinical Trial

Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published inThe BMJandPLOS Medicine

Measuring Post-Partum Haemorrhage in Low-Resource Settings: The Diagnostic Validity of Weighed Blood Loss versus Quantitative Changes in Hemoglobin

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