2 Young Lives: mentoring teenagers for safer pregnancy and birth in Sierra Leone

Current feasibility outcome measures as of 17/11/2022:
1. The number of participants identified, recruited and retained, measured using routinely collected data at pregnancy, at birth, at 6 weeks, and 1 year after birth
2. The number of participants ineligible or withdrawing from the study, and data collection and completion of outcome measures, measured using routinely collected data at pregnancy, birth, 6 and 1 year after birth
3. Selection of most appropriate primary outcome measure and sample size calculation, measured at pregnancy, birth, and 6 weeks after birth

Previous feasibility outcome measures:
The feasibility of a future definitive trial assessed using:
1. The number of participants identified, recruited and retained, as measured using routinely collected data at pregnancy, at birth, at 6 weeks, and 1 year after birth
2. The acceptability and experience of the trial process including ineligibility or withdrawal from the study, randomisation, rolling programme, and data completion of outcome measures, measured using routinely collected data, interviews, focus groups and report forms monthly, at 6, 9-12 months after birth
3. The performance of the selected primary outcome in relation to the level of acceptability and relevance, measured using focus groups, interviews and report forms monthly, at 6, 9-12 months
4. Data completeness at follow up, variance of the likely primary outcome and variability of intervention across individuals and sites, measured using routinely collected data, report forms, interviews and focus groups at 6 weeks, monthly, 6, 9-12 months

Primary clinical outcome measures:
The primary clinical outcome is a composite of:
1. Maternal death (all-cause, occurring during pregnancy, labour, or within 42 days of birth), measured using routinely collected data following birth and 6 weeks after birth
2. Stillbirth (born with no signs of life at or after 28 weeks of pregnancy, but before or during birth), measured using routinely collected data following birth
3. Neonatal death (deaths among live births during the first 28 days), measured using routinely collected data following birth and 6 weeks after birth

Secondary outcome measures:
1. Maternal outcomes measures including i.e. IPT for malaria, number of tetanus toxoid immunisations, caesarean sections, birth at facility, postpartum haemorrage, place of birth, presence of birth attendant, measured using routinely collected data following birth; and contraception uptake measured using routinely collected data and interviews at 6 weeks, 9-12 months after birth; recurrent pregnancy measured using interviews at 9-12 months after birth.
2. Perinatal outcomes measures including birthweight, Apgar score at 5 minutes, newborn resuscitation, breastfeeding, Kangaroo mother care, admission to neonatal unit, measured using routinely collected data following birth; postnatal immunisation uptake measured using routinely collected data at 6 weeks after birth; and 1-year infant death measured using routinely collected data at 1 year after birth
3. Process and implementation outcomes measures including:
3.1. Antenatal checks, antenatal checks with blood pressure measurement, referrals, postnatal check, measured using routinely collected data following birth and 6 weeks after birth
3.2. Acceptability/satisfaction with the intervention among girls, mentors, healthcare providers and local stakeholders, measured using routinely collected data, interviews and focus groups at 6, 9-12 months
3.3. Reach/number of participating girls when compared to the site population included, measured using routinely collected data at 9-12 months
3.4. Adoption/engagement and uptake of the mentoring scheme, measured using routinely collected data, interviews, and focus groups monthly, 6, 9-12 months
3.5. Fidelity/intervention implemented as intended i.e. number of mentors and team coordinators recruited, number of trainings and workshops, weekly 1:1 meetings, monthly social gatherings, women being accompanied by mentees to register for antenatal care, during labour and to purchase first supply of goods; number of visits from mentor to mentee’s family, measured using routinely collected data, report forms, interviews, and focus groups monthly, 6, 9-12 months
4. Adolescent girls’ experiences by exploring their views and perspectives on the mentoring, maternity care, thriving, economic, social progress/wellbeing, and potential mechanisms of change, measured using interviews, photovoice at 9-12 months
5. The feasibility of measuring resource use and costs benefits associated with the mentoring scheme measured using cost-consequence analysis at pregnancy, at birth, at 6 weeks, and 1 year after birth