Kavak 2013.
Study characteristics | ||
Methods | "Randomised prospective single blind trial" (p 706) Setting: university hospital setting in Turkey |
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Participants | Women with complete placenta praevia and intractable bleeding (n = 13) following caesarean section.
PPH was not defined. Exclusions: serious medical, haematological or surgical diseases; placental implantation anomalies such as placenta accreta/increta/percreta; history of thromboembolism; emergency CS; macrosomia; poly ‐hydramnios; preeclampsia; gestational diabetes; intrauterine growth retardation; and presence of multiple gestations. |
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Interventions |
Intervention: Bakri balloon tamponade intraoperatively through uterine incision (7 women) ‐ was inflated with saline (100 mL to 200 mL) "according to the uterine size" p 706 Control: Endouterine haemostatic square suturing to the lower segment of the uterus (6 women). 4‐5 sutures were applied. All women were given prophylactic antibiotics. |
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Outcomes |
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Notes |
Trial authors' declarations of interest: the authors state that they have no conflicts of interest. Sources of trial funding: not reported. Trial dates: August 2011 to August 2012 Informed consent obtained? yes Ethics approval obtained? yes, from the local research ethics committee Did we attempt to contact the trial authors?: email to Dr Kavak on 25 Aug 2018 requesting data on blood loss following transfusion only (not total blood loss). No response as of 1 March 2019. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Trial report states "randomly divided" ‐ insufficient information provided |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Reported to be a single‐blind trial but no further information explicitly provided, although women were under general anaesthesia so presumably effectively blinded whilst undergoing intervention. Assume blinding of surgical personnel not possible due to difference in intervention techniques between groups. (Blood loss during the operation calculated by the anaesthetist (evaluation of blood collected via suction plus weighing of absorbant pads) ‐ reasonably objective. During first 24 hours, postoperative blood loss measured by weighing pads worn by patients ‐ again, this is reasonably objective so we question the extent to which lack of blinding would matter ‐ it may have had lots of small impacts on clinical decision‐making) |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to assess ‐ reported to be a single‐blind trial but no further information provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Other bias | Low risk | No other sources of bias identified |