Wang 2011.
Methods | RCT, Fourth Hospital of Suzhou University, China. | |
Participants | 300 nulliparous women undergoing elective CS under combined epidural and spinal anaesthesia were randomly divided into chewing‐gum group (150) and control group (150). Inclusion criteria: "first baby, ability to chew, intraoperative epidural anaesthesia plus spinal surgery, use of patient‐controlled analgesia pump". Exclusion criteria: "severe pregnancy‐induced hypertension, pre‐eclampsia or eclampsia, intraoperative intraperitoneal adhesions intraoperative complications, bleeding, surgical time > 2 hours, postoperative fever, need blood transfusion and reoperation". 34 women excluded in CS group (22.7%) and 33 (22%) in control group due to complications (e.g. transfusion, fever, adhesions, surgery > 2 hours), leaving 233 women in analyses. Mean age: 25.9 ± 5.0 years (intervention group), 26.7 ± 4.2 years (control group). |
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Interventions |
Intervention group (N = 116): chewed 1 xylitol sugar‐free gum for 15 min at 2‐h intervals, from 2 h after surgery during the day time until first flatus. Time spent chewing gum > 60 min/d, based on mean time to first passage of flatus. Control group (N = 117): no food/beverage; water or liquid feed was provided after first bowel sound (conventional feeding). |
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Outcomes | Time to first flatus, time to first bowel sounds. Additional outcome: motilin levels in peripheral blood samples after CS. | |
Notes | No study protocol available | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information: "...were randomly divided into chewing gum group (150) and control group (150)". |
Allocation concealment (selection bias) | Unclear risk | No information available. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The nature of intervention did not allow blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Participants were unable to be adequately blinded in relation to passage of flatus. |
Blinding of outcome assessment (detection bias) Objective outcomes | Unclear risk | No information on blinding of assessors evaluating time to first bowel sounds. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Losses balanced but higher than 20% in both groups: 22.7% and 22% in intervention and control groups, respectively. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes proposed in Methods were reported in Results. No study protocol available. |
Other bias | Unclear risk | No information available. |