Chananeh 2018.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Persian Gulf Shohada Hospital of Bushehr Hospital Participants: 100 multiparous women, aged 15 ‐ 44 years, with natural delivery complaining of moderate‐to‐severe postpartum pain as measured using VAS 2 hours after delivery; women with pain score > 4 enrolled Inclusion criteria: 1.Being Iranian; 2. can read and write; 3. vaginal delivery; 4. spontaneous exit of placenta and membranes; 5. Multiparous; 6. gestational age between 37 ‐ 42 weeks; 7. complained of moderate or severe pain after delivery; 8. feeding is started and will be continued; 9. mother age between 15 ‐ 44 years; 10. deliver a singleton and healthy baby Exclusion criteria: 1. Instrumental delivery or pressure on uterus; 2. 3rd or 4th degree laceration;.3. history of caesarian section or pelvic operation; 4. use of any narcotic drug during labor and delivery or used at least 4 hours ago; 5. used epidural or spinal anaesthesia during labour and delivery; 6. mother has any drug addiction; 7. maternal history of herbal drug allergy; 8. maternal history of chronic disease Exclusion criteria during trial: 1. herbal drug sensitivity in mother during study; 2. mother uses other methods or drugs to relieve pain during study. 3. mother is suffering serious complications after delivery (such as high blood pressure, severe bleeding after childbirth, fever, etc.); 4. breastfeeding discontinued for mother or baby reasons; 5. mothers withdraws consent |
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Interventions | 1. Nigella sativa (500 mg capsule) + mefenamic acid (250 mg capsule), women received 4 tablets, 6 hourly for 24 hours; n = 50 2. Placebo + mefenamic acid (250 mg capsule), women received 4 tablets, 6‐hourly for 24 hours; n = 50 | |
Outcomes | Severity and duration of pain measured using VAS before, and 1 hour after medication administered. Side effects | |
Notes | Dates of study: 05 May 2017 ‐ final date not available (information from trial registration) Sponsor: Faculty of Nursing and Midwifery, Shahid Behesti Medical Science University Declarations of interest: none stated. Abstract in English, full paper in Perisan. Author emailed 8 February 2020 Translation requested 22 July 2020 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised double‐blind clinical trial Method of randomisation not stated |
Allocation concealment (selection bias) | Unclear risk | No information provided to permit judgement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | All women received 1 capsule of mefenamic acid, women in the intervention group additionally received a capsule of Nigella Sativa, women in the control group received a capsule similar in appearance to the Nigella Sativa but without Nigella Sativa Paper states "mothers and investigators were blinded". |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Paper states "mothers and investigators were blinded" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Results reported for all randomised women |
Selective reporting (reporting bias) | Low risk | Stated outcomes were reported. Trial registration available |
Other bias | Unclear risk | Abstract only in English, full text required translation |