Yasmeen 2014.
Methods | Randomised controlled trial | |
Participants |
Setting: “Labour room Gyne unit”, department of obstetrics and gynecology, BVH, Bahawalpur, Pakistan. Duration of study: February, 2013 to August, 2013. Participants randomised: N = 60 Inclusion criteria: “Patients of para 2 and para 5 with age from 25 to 35 years, Uncomplicated single cephalic term pregnancy, Candidates for vaginal delivery and patients with 40‐41 weeks estimated gestational age (by early pregnancy scan)”. Page 876 Exclusion criteria: “primigravidae, grand multipara, high risk pregnancy and patients presentation other than cephalic”. Page 876 Parity: only multiparous women included. Bishop score: not recorded |
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Interventions |
Membrane stripping (N = 30): “sweeping membrane was done.” “digital separation of 2‐3cm of the membranes from lower uterine segment by rotating the finger at least twice through 360 degrees was done. A closed cervix was stretched digitally until membrane sweeping could be carried out. A closed cervix that would not admit a finger was vigorously massaged. Women who underwent sweeping was told that spotting or blood stained cervical mucus may appear.” Page 876 Control group (N = 30): “no sweeping was done.” Page 876 |
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Outcomes | Spontaneous labour within 48 hours | |
Notes |
Funding: not stated Trial authors’ declaration of interest: not stated Informed consent obtained: yes, “after informed consent” Page 879. Ethical approval: not stated Email sent to clarify data on 12 April 2017. Email re‐sent 30 August 2017 to request further information. No reply to date. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not reported…”patients were randomized” Page 876 |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants: not discussed. Personnel: not discussed. Unlikely clinicians have been blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of attrition bias. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make informed decision.Main stated outcome was proportion of women achieving spontaneous labour within 48 hours. This is not clearly reported. Email sent to author to clarify on 12 April 2017. No reply to date. |
Other bias | Low risk | No information given on first 4 domains. However, no evidence of other bias. |