Allen 2013.
Methods |
Study design: RCT. Duration of study: 2010‐2011. |
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Participants | Setting: inner city tertiary maternity hospital and associated community‐based clinic, Australia. Inclusion criteria: women were eligible for trial entry if they were: (a) aged between 13‐17 years of age (b) booked for public maternity care at the study hospital c) 23 weeks pregnant or less, d) single live fetus at time of recruitment. Exclusion criteria: maternal age 18 years or older, inability to provide consent (e.g. serious mental illness or lack of English fluency), residence outside of the hospital catchment area (because of the requirement for home visiting), 24 weeks gestation or greater, and multiple pregnancy. Participants randomised: 1 midwife‐led care, 0 to standard care. | |
Interventions |
Experimental: women randomised to the intervention received antenatal, intrapartum and postnatal care from a known midwife. Control: women randomised to the control group were able to select any other available model of antenatal care including YWC, care with a GP, or a community‐ or hospital‐based antenatal clinic. |
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Outcomes | Outcomes considered in the review and reported in or extracted from the study: Preterm birth Gestation Birthweight Mode of birth Apgar score less than 7 at 5 minutes Breastfeeding initiation Breastfeeding at hospital discharge Admission to a separate neonatal nursery Length of maternal and neonatal stay |
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Notes | This study was a feasibility study for a proposed randomised trial. Only 1 woman was recruited to receive the intervention, and the study was not continued. Authors concluded that an RCT with pregnant adolescents was not feasible according to specifications of the protocol. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Methods of randomisation not described. |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Blinding not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding not described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | This study was a feasibility study. Only 1 woman received the intervention. This study contributed no data to the review. |
Selective reporting (reporting bias) | Unclear risk | This study was a feasibility study. Only 1 woman received the intervention and no outcome data were reported. |
Other bias | Unclear risk | This study was a feasibility study, and the study authors concluded that recruitment was not feasible according to the specifications outlined in the study protocol. |