Alcoseba‐Lim 1992.
Methods | Prospective randomised controlled trial. | |
Participants |
Setting: Chong Hua Hospital, Cebu City, Philippines. Duration of study: 6 months (1 August 1991 to 31 October 1992) Inclusion criteria: women of 38 weeks' gestation based on “declared last menstrual period and the fundal height at each prenatal visit.” The “result of the ultrasound done before 26 weeks age of gestation was used to confirm age of gestation”. Page 139. Exclusion criteria: “Uncertain dates for gestational age (with size dates discrepancy not confirmed by ultrasound < 26 weeks). Abnormal fetal presentations. History of vaginal spotting during the course of current pregnancy (suspects of low‐lying placenta, placenta previa).” Patients who had a history of a “previous caesarean section who did not want to try vaginal birth”. Page 140. Parity: mixed. Both nulliparous and multiparous women included (% presented in Table 2 of manuscript page 140). 28/65 (43.1%) nulliparous women in membrane sweeping group versus 24/65 (36.9%) nulliparous women in control group. 37/65 (56.9%) multiparous women in membrane sweeping group versus 41/65 (63.1%) multiparous women in the control group. Bishop score: (% presented in Table 2 of manuscript page 140) Bishop score at initial visit: Stripped Non stripped </= 4 61 40 > 4 4 25 |
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Interventions |
Membrane stripping(n = 65): patients “undergo membrane stripping once every week until delivery.” “Accomplished by digital separation of the chorionic membrane from the lower uterine segment with one or two circumferential passes.” “In patients with long and closed cervices, the cervix was digitally stretched until stripping could be accomplished” Page 139 Control group (n = 65): weekly “pelvic examination and bishop scoring was done”. Page 139 All the patients were examined by the same examiner. Page 139 |
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Outcomes | Spontaneous vaginal delivery Low forceps delivery Caesarean section Chorioamnionitis Meconium staining |
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Notes |
Funding: Nestle Phils, Medichem Pharmaceuticals Inc, Pfeizer Trial authors’ declaration of interest: none stated Informed consent obtained: not stated Email sent 28 August 2017 requesting further information. Resent 20 September 2017. No reply to date. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Random sequence generation not method reported “ the subjects were then randomly assigned to a group”. Page 139 |
Allocation concealment (selection bias) | Unclear risk | No evidence of allocation concealment given. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No evidence of blinding of participants or personnel demonstrated. Participants: no reported. Personnel: not reported. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No evidence of blinding of outcome assessment demonstrated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of attrition bias |
Selective reporting (reporting bias) | Unclear risk | It is noted that page 141 of study states “Vaginal spotting was observed in 20(30.7%)”. However table 5, page 141 reports: spotting n = 17 (26.2%) |
Other bias | High risk | Imbalanced groups for initial Bishop score, page 141. |