Simbar 2015.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Setting: Alzahra Hospital, Tehran, Iran. From April 2011 to February 2012
Inclusion criteria: primi‐ or multiparous women with moderate‐to‐severe after‐pain (score > 4 on VAS and with need for analgesia), normal vaginal delivery Exclusion criteria: women with birth complicated by perineal laceration, prolonged labour, macrosomia, instrumental birth, analgesics in previous 2 weeks |
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Interventions | Following initial assessment of pain, women were randomly allocated to 1 of 2 groups:
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Outcomes | Adequate pain relief as reported by the women
Pain however reported by the authors:
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Notes | Funding sources: Goldaru Company ‐ manufacturer of Menstrogol Declarations of interests: the authors declare that they have no conflicts of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information related to sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote: "participants randomly selected a packet that was coded A or B containing 4 capsules of PAC of MAC". Unclear if codes visible |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Single‐blind, assume participants were blinded but personnel may not have been blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Trial registration states that study is double‐blind but publication states single‐blind. Therefore unclear if they were excluded if they experienced any side effects or requested to withdraw from the study. Unclear how many participants applied to withdraw |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The trial included 108 women, 54 in each group. Pain severity before and after treatment does not include the number of women. Latency for medication effect reports data from 54 women in each group. Study report states that "participants were excluded if they experienced any side effects or requested to withdraw from the study". Unclear how many participants this applied to |
Selective reporting (reporting bias) | High risk | Trial registered retrospectively |
Other bias | Low risk | No other risk of bias identified |