Midhet 2010.
| Methods | Cluster‐randomised controlled trial implemented during 1998 to 2002 in 32 village clusters in Khuzdar, a rural district of Balochistan province in Pakistan | |
| Participants | Women of reproductive age and their husbands (n = 2561) | |
| Interventions | Information and Education for Empowerment and Change (IEEC) (n = 836) for women was designed to increase awareness of safe motherhood and neonatal health. Each facilitator initially invited 10 to 12 women from close villages to participate in a support group. Local traditional birth attendants (TBAs) ‐ who deliver over 90% of all births in the project area ‐ were trained in clean home delivery and in recognising common obstetrical and newborn emergencies. The project also facilitated timely referral and transportation of obstetrical and newborn emergencies to the district hospital. A typical support group started with a discussion of the problems faced by women during pregnancy and childbirth. Participants were then asked to look at their booklets while listening to a cassette tape that guided them through the pictures in the booklet. The pictures formed part of the dramatised stories recorded on the tape, thus creating an audiovisual effect. The booklet covered the following topics: family planning; nutrition; preparation for pregnancy and delivery; and danger signs during pregnancy, at delivery, and postpartum. Typically, the booklet was finished in 6 sessions of 1 to 2 hours each, after which participants were entitled to have their personal copy of the booklet and audiocassette. The husbands' IEEC (n = 703)was implemented in 8 village clusters randomly selected from the 16 intervention clusters. Husbands' booklets and audiocassettes were designed after formative research with married men. Then in each village cluster, 20 to 30 male community volunteers were identified who distributed the materials among husbands of the women who had participated in the support groups The control group received standard care (n = 1022) |
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| Outcomes | Primary outcomes: neonatal mortality, perinatal mortality Secondary outcomes: iron supplementation, tetanus immunisation |
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| Notes | Funding: funded by NICHD, USAID, UNICEF, World Health Organization, British Council, Government of Japan, and The Asia Foundation, and implemented by The Asia Foundation’s Islamabad office. There is no statement related to the involvement of these funding parties in design and conduct of the study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomisation took place separately within each of the three zones; equal numbers of village clusters were randomly allocated to the intervention or control sites (by blindly drawing village cluster names written on folded chits)" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "randomisation took place separately within each of the three zones; equal numbers of village clusters were randomly allocated to the intervention or control sites (by blindly drawing village cluster names written on folded chits)" Comment: probably done |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: insufficient information to permit any judgement |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to permit any judgement |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: insufficient information to permit any judgement |
| Selective reporting (reporting bias) | Unclear risk | Comment: this is not a registered trial, but outcomes mentioned in the methods section are reported in the results section |
| Other bias | Low risk | Study seems to be free from other biases |