Adeniji 2013.
Methods | Prospective randomised controlled trial | |
Participants |
Setting: antenatal clinic, Ladoke Akintola University of Technology Teaching Hospital, Osogbo, Nigeria. Duration of study: 3 years (between April 2007 and March 2010) Inclusion criteria: “singleton live fetus, post‐term pregnancy from 40 weeks and 1 day to 40 weeks and 9 days, intact fetal membranes, Bishops score ≤ 5 and cephalic presentation”. Page 5. Exclusion criteria: “post‐term pregnancies of > 40 weeks and 10 days, multiple pregnancies, grand multiparity, cephalopelvic disproportion, previous caesarean section or a uterine scar, fetal malpresentation, fetal distress, placenta praevia, antepartum haemorrhage, premature rupture of the membranes and medical disorders.” Page 5. Parity: mixed, both nulliparous and multiparous included in the study. Page 5. Bishop score: not recorded |
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Interventions |
Oral misoprostol group (OM) (N = 50): “a single 50 ug misoprostol tablet orally on an outpatient basis.” Page 5. Membrane stripping group (MS) (N = 46): “had MS once only at the antenatal clinic. Patients with unyielding cervices preventing access into the cervical canal were termed 'failed MS'.” Page 5. “All patients in both groups who did not go into spontaneous labour after 48 hours were categorised as 'failed labour induction' and together with the women with post‐term pregnancies of > 40 weeks and 10 days managed according to our departmental protocol of cervical ripening and labour induction (transcervical Foley catheter or intravaginal misoprostol) to ensure delivery before 42 weeks' gestation.” Page 5. |
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Outcomes | Spontaneous labour Vaginal delivery Caesarean section Apgar score < 7 at 5 minutes Women’s satisfaction Oxytocin augmentation |
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Notes |
Funding: none declared Trial authors’ declaration of interest: none declared Informed consent obtained: yes; “were recruited after giving informed consent”. Page 5. Ethical approval: “The institutional ethical review committee approved the study”. Page 5. Email sent to author 28 August 2017 requesting study data and subgroup data Re‐sent 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) | Low risk | “Computer‐generated random numbers were used for patient allocation”, page 5. |
Allocation concealment (selection bias) | Low risk | “sealed opaque envelopes containing papers marked OM or MS (50 each) were placed in a box, thoroughly mixed and then numerically labelled.”, “ were allocated sequential numbers in order of recruitment…and the correspondingly numbered envelope was opened”, page 5. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants: not discussed. Blinding of personnel: partial blinding. “attending obstetricians in the labour ward were blinded to the labour‐inducing agents used in the study groups.” (Page 5). Unclear if all other personnel involved were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | n = 4 (8%) patients in nulliparous group could not have MS owing to inability to gain access to the cervical canal and were removed from analysis |
Selective reporting (reporting bias) | Unclear risk | Rates for hospital admission not reported explicitly |
Other bias | Low risk | No other bias indicated. |