Klerman 2001.

Methods	Parallel‐arm individually‐randomised RCT conducted in the USA between Mar 94 and Jun 98.
Participants	Sample size: 656 women. Inclusion criteria: African American, eligible for Medicaid, less than 26 weeks' gestation, at least 16 years old, score of 10 or higher on a risk assessment scale. Exclusion criteria: alcoholism and substance abuse, asthma, cancer, diabetes, epilepsy, high blood pressure, sickle cell disease and HIV/AIDS.
Interventions	Target: health system (additional and longer appointments) and community (IEC). Arm 1: educational intervention informing women about their risk conditions and what behaviours might improve their pregnancy outcome. Augmented care included educationally oriented peer groups, additional appointments, extended time with clinicians, and other supports. Arm 2: control (no intervention).
Outcomes	Trial primary outcomes: pregnancy outcomes, women's knowledge of risks, satisfaction with care. Review outcomes reported: Primary: not reported. Secondary: preterm birth, low birthweight infants. Other: average no. of ANC visits. Follow‐up: every 2 weeks, until the last month of pregnancy then every week.
Notes	Funders: Federal Agency for Health Care Policy and Research to the University of Alabama at Birmingham, USA.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Sequence generation not described.
Allocation concealment (selection bias)	Low risk	"sealed envelopes."
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"interviewers blinded" to treatment allocation. Additional outcome data taken from clinic records, data collection forms and a computerised database.
Recruitment bias (for cluster RCTs)	Low risk	Not applicable.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Missing data < 10%. 656 women enrolled, but data available for 619; 12 women with fetal deaths excluded from analysis (intervention group: 3 before 20 weeks and 4 after; controls: 3 before 20 weeks and 2 after).
Selective reporting (reporting bias)	Low risk	Relevant outcomes reported.
Analysis bias	Unclear risk	ITT not stated.
Other bias	Low risk	No baseline imbalances.
Overall risk assessment	Low risk	No serious risk of bias concerns.