Morhason‐Bello 2009.
Methods | RCT | |
Participants | 603 women from Ibadan, Nigeria with anticipated vaginal delivery were enrolled between 30 and 32 weeks' gestation at an antenatal clinic (305 to intervention and 298 to control) from November 2006 to March 2007 | |
Interventions | Those in the experimental group were informed to bring someone of their choice to act as a companion during labour. On arrival in labour the accompanying companions were provided with an information leaflet that explained their responsibilities. These included: gentle massage of the woman’s back during contraction, reassuring words, spiritual support inform of prayers and also acting as intermediary between the woman and healthcare team. After studying the leaflets, they were allowed to seek clarifications. The information leaflet was also interpreted for those that are not literate. The attending midwife allowed and ensured companions performed their expected duties throughout. The companions were told to offer continuous support – they were to be by the patient’s side except for feeding and use of toilet until 2 hours after childbirth. Husbands were the most common support person (65.4%). The women in the control group had only routine care where relatives of patients are usually barred from the labour ward |
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Outcomes | Caesarean section rate, active phase of labour duration, pain score, need for analgesia, need for oxytocin augmentation, time from delivery to initiation of breastfeeding and the emotional experience during labour. | |
Notes | Epidural analgesia was not available and it was not stated whether EFM was used routinely. We have requested further details from the authors. The randomisation process was well done, but resulted in an imbalance in socioeconomic status between the groups. Women in the experimental group tended to be more educated (82% versus 48% with tertiary level) and skilled workers (78% versus 39%). This imbalance was noted and discussed by the authors Dates of study: November 2006 ‐ 30 March 2007 Funding: received financial support from the Gates Institute, Bloomberg School of Public Health Johns Hopkins University through the Center for Population and Reproductive Health, College of Medicine University of Ibadan, Nigeria. Conflicts of interest: not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The randomisation sequence was generated using a table of random numbers" |
Allocation concealment (selection bias) | Low risk | "Random permuted blocks of size four were used to ensure a balanced design." "Based on the sequence of treatments generated using this method, treatment groups (A and B) were written on pieces of cardboard paper and put into sealed opaque envelopes. Each of the opaque envelopes had a serial number on it." "Two trained research assistants (RAs) non‐medical staff, supervised the randomisation procedure at every clinic. On each clinic day, consented women that met the inclusion criteria were given serial numbers with allotted treatment group based on their arrival time. Only the statistician and RAs had access to the list of numbers used to prevent clinicians’ influence on the randomisation. Each participant opened the opaque envelope in the presence of an RA, and the assigned treatment group was recorded on the woman’s medical record file." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, participants' families, and labour room staff were not blinded to group allocation |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The treatment group was noted in the chart so it is likely that the data collectors were unblinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Follow‐up was completed for 97% of the sample |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | Low risk | No other sources of bias noted |