Soltan 2007.
| Study characteristics | ||
| Methods | Randomised controlled trial The trial report says it is a "Randomized clinical trial/cross over study" (in the abstract only). Although some members of the control group do receive the intervention, the methods described in the report are not those of a cross‐over trial; the fact that the women in the control group received the intervention was not 'designed in': according to their methods it does not seem to be pre‐specified in the trial design. Setting: Beni‐Mazar District Hospital, El‐Menia, Egypt |
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| Participants | 240 women with PPH, due to atony, following vaginal birth at home or in hospital PPH is not defined in the trial report, and there is no information on how blood loss was assessed. Exclusions: "cases of PPH due to traumatic, retained placental tissues, other cause and after cesarean delivery" p54 |
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| Interventions |
Intervention: woman received the 'El‐Menia' balloon plus cervical stitch to "prevent herniation of the inflated balloon through the dilated cervix" (p54), plus standard care (see below). The El‐Menia balloon tamponade consists of an orange latex party balloon (0.19 mm thick) attached to a 15 cm long Nelton catheter. The balloon was inflated with air using a sphygmomanometer to 140 mmHg and then attached to the catheter using silk suture "tied over tightly several times... to prevent air escape" P54. To keep the balloon in place, cervical cerclage was applied ("at 3 and 9 o'clock" p54). Women in this group also received antibiotic prophylaxis: gentamycin 80 mg, metronidazole 500 mg, and ampicillin 500 mg, immediately after the balloon was inserted and every 8 hours thereafter for the subsequent three days. (120 women) Control: standard care ‐ "women were treated with uterine massage and ecbolics according to WHO protocol" p 54 (120 women) Women receiving the intervention were also given metronidazole 500 mg, gentamycin 80 mg, and ampicillin 500 mg after insertion of the balloon, every 8 hours for 3 days. |
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| Outcomes |
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| Notes |
Trial authors' declarations of interest: not reported Sources of trial funding: not reported Trial dates: 2003 to 2004 (precise date not given) Ethical approval? yes "the study design was approved by El‐Menia Faculty of medicine ethical committee" p54 Informed consent? Women were admitted to the study after their husbands gave informed consent Contacted trial authors? Yes. We attempted to email Professor Soltan on 20 January 2020 but did not receive a reply. The trial methods specified that all women in the control group would receive standard care as the first‐line treatment. However, 19/120 women in the control group subsequently received UBT as a second‐line treatment. The authors preserved intention‐to‐treat (those 19 women remained in the control group). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation (no further details provided) |
| Allocation concealment (selection bias) | Low risk | Closed opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding not mentioned. Assume blinding of personnel not possible due to difference in intervention techniques between groups |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not mentioned |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data apparent |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available. Insufficient information to make an assessment of reporting bias |
| Other bias | High risk | 19 women in the control group also received the intervention as a second‐line treatment. This secondary use of UBT was not prespecified in the methods. No other sources of bias were apparent |
Hb: haemoglobin; ICU: intensive care unit; PPH: postpartum haemorrhage; UBT: uterine balloon tamponade.