Nagle 2002.

Methods	3‐arm RCT. Individual women randomised.
Participants	Setting: pregnant women attending state public health clinics in 3 parishes in Louisiana USA 1999‐2000. Inclusion criteria: pregnant women less than 28 weeks’ gestation with no previous live births and Medicaid eligible.
Interventions	Experimental intervention: 2 intervention arms that were combined in the results. Nurse home visits with visits during pregnancy and up to the child being 2 years old. Details of the content of visits were not described in detail. As 1 but the nurse home‐visiting team included a mental health specialist. Control/Comparison intervention: usual care (not clearly described).
Outcomes	This thesis mainly reports on participation and adherence.  Long‐term outcomes included child development, abuse and neglect, injury, subsequent pregnancy, mother‐child interaction and maternal employment. At follow‐up in the third trimester (28‐34 weeks) and at 6‐8 months postpartum results were described for depression (Beck Depression Inventory) and for partner violence (current and previous) (partner violence interview) with 13 items on physical violence (0 – never experienced, 1 – has experienced) (the time frame for reporting violence was not described).
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was carried out by an external agency.
Allocation concealment (selection bias)	Low risk	It was stated that the nurses carrying out recruitment had no influence over randomisation which was carried out by an external agency (allocations were obtained by telephone).
Incomplete outcome data (attrition bias) All outcomes	High risk	357 women consented to participation and were randomised (241 in intervention groups and 116 controls). There was considerable loss to follow‐up and deviations from protocol. 19.5% of intervention women received no intervention.  32.8% did not complete the first follow‐up interview at 28‐34 weeks, and an additional 9% of the women did not have this interview until after the birth of the baby and data were therefore not included in the analysis (206 followed up at interview one and 181 available at the postpartum follow‐up). Loss was balanced across groups but this loss to follow‐up and the large number of women not receiving the allocated intervention means that results are difficult to interpret.
Selective reporting (reporting bias)	Unclear risk	This thesis concentrated on only a limited part of the overall research project. The large number of analyses means that some significant results may have occurred by chance.
Other bias	Unclear risk	There was little information on some aspects of the trial design.  We are not aware that other results from this trial have been published. Groups appeared similar at baseline.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and staff were aware of group assignment.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Participants and staff were aware of group assignment. Knowledge of treatment group may have affected reporting of outcomes.