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Table 2 Description of the surveillance systems used in the three trials

From: Implementing effective community-based surveillance in research studies of maternal, newborn and infant outcomes in low resource settings

Trial name ObaapaVitA Newhints Neovita
Trial design Cluster-randomized, double-blind, placebo-controlled Cluster-randomized, usual care controls Individually-randomized, double-blind, placebo-controlled
Eligible population All women in women aged 15–45 years living in seven rural districts in Brong Ahafo Region in Ghana capable of giving informed consent and planning to live in the trial area for at least 3 months Neonates who were at least two hours old; on the day of birth or in the next two days; able to feed orally; and likely to stay in the area for at least 6 months
Dates of data collection Phased start by site:
12/2000–10/2008 (Kintampo N and S)
06/2001–10/2008 (Wenchi and Tain)
06/2002–10/2008 (Techiman)
01/2003–10/2008 (Nkoranza N & S)
Surveillance system that had been established for ObaapaVitA continued from 11/2008 to 12/2009 Enrolment started in 08/2010
Last infant followed to 12 months of age at 11/2012
Frequency of visits Every 4 weeks, to all enrolled women Every 4 weeks to all enrolled women
In July 2009, because of budget constraints, this frequency was reduced to visits every 8 weeks and restricted to women who were pregnant and infants
All reproductive age women visited every 12 weeks
All pregnant women visited every 4 weeks until 8th month of pregnancy and daily in the last month of pregnancy
All infants visited every 4 weeks until status of infant at 12 months of age was ascertained
Data collection team Fieldworkers, who were supervised by site leader, co-ordinators, and supervisors; senior supervisors for more complex data collection; dosing supervisors in Neovita
Tasks completed during fieldworker visits 1. Collect 4-weekly data
2. Distribute intervention and control capsules
3. Enrol new eligible women (e.g., if they had moved in or turned 15)
1. Collect 4 weekly data
2. Enrol new eligible women (e.g., if they had moved in or turned 15)
1. Collect 4- or 12-weekly data
Primary outcome(s) 1. Pregnancy-related mortality
2. All-cause mortality in women of reproductive age
1.All-cause neonatal mortality 1. Post-supplementation infant mortality to 6 months of age
Secondary outcomes 1. Severe maternal morbidity
2. Stillbirths
3. Perinatal mortality
4. Neonatal mortality
5. Infant mortality
1. Age-specific neonatal mortality
2. Cause-specific neonatal mortality
3. Behavioural outcomes (that is, how many women practiced the Newhints behaviours)
1. Post-supplementation neonatal mortality
2. Post-supplementation infant mortality
3. Post-supplementation neonatal morbidity
4. Adverse events
Other data collection or visits 1. Additional forms completed by supervisors with additional training (e.g., verbal autopsies, adherence)
2. Hospital based surveillance (from 01/2004), to collect data on maternal morbidities
1. Verbal autopsy forms completed by supervisors with additional training
2. In intervention zones, CBSVs aimed to visit women twice during pregnancy and three times after birth (on days 1, 3, and 7)
1. Verbal autopsy forms completed by supervisors with additional training
2. Dosing supervisors gave the study capsules to enrolled newborns in the community and in birthing facilities, and collected adverse event data on days 1 and 3