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Table 2 Primary and secondary outcome indicators

From: Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda

Primary outcome indicators

Definition

Methods to obtain outcome

 Fresh Stillbirth rate

Number of fresha stillbirths of at least 1000 g expressed per 1000 live and stillbirths

Perinatal e-registry

 In-facility early perinatal mortality

Number of fresh stillbirths (as above) and up-to discharge neonatal deaths per 1000 live and stillbirths (composite indicator)

Perinatal e-registry

Secondary outcomes

 Hypoxic-ischaemic event rate

No of neonates with APGAR < 7 at 5 min per 1000 live and stillbirths

Perinatal e-registry

 Hypoxic-ischaemic event rate

Umbilical cord lactate of > 5.5 mmolb per 1000 live and stillbirths

Perinatal e-registry, (sub-sample)

 Neonatal seizures

No of neonates diagnosed with seizures per 1000 live and stillbirths

Perinatal e-registry

 Caesarean section rate (%)

No of caesarean section per 100 live and stillbirths

Perinatal e-registry

 Severe maternal morbidity

No of women with morbiditiesc per 1000 live and stillbirths

Perinatal e-registry

 Responsiveness (%)

Validated questionnaire [39] (% score) per 100 live and stillbirths

Survey among women at discharge (exit interviews)

 Mistreatment (%)

Proportion of women reporting mistreatment per 100 live and stillbirths

Survey among women at discharge (exit interviews)

Process indicators (selected)

 Detection of foetal distress

No. of detected foetal distress events per 100 deliveries defined by FIGO [40]

Perinatal e-registry

 Decision-to-birth time for caesarean section

Median time (minutes) between decision to do a caesarean section to the birth of the baby

Perinatal e-registry

  1. aFresh stillbirth is defined a stillbirth that happened during labour at the respective facility, thus where the foetal heartbeat was positive at admission; bThe cut-off level may be revised based on data from an ongoing study in Uganda and validation work; cSevere maternal morbidity will be defined using pragmatic criteria of major interventions (hysterectomy, laparotomy, blood transfusion, admission to intensive care unit or referral to higher level facility)