Effect of the CRADLE vital signs alert device intervention on referrals for obstetric haemorrhage in low-middle income countries: a secondary analysis of a stepped- wedge cluster-randomised control trial
BMC pregnancy and childbirth. 2021;21(1):317
BACKGROUND Obstetric haemorrhage is the leading cause of maternal death worldwide, 99% of which occur in low and middle income countries. The majority of deaths and adverse events are associated with delays in identifying compromise and escalating care. Management of severely compromised pregnant women may require transfer to tertiary centres for specialised treatment, therefore early recognition is vital for efficient management. The CRADLE vital signs alert device accurately measures blood pressure and heart rate, calculates the shock index (heart rate divided by systolic blood pressure) and alerts the user to compromise through a traffic light system reflecting previously validated shock index thresholds. METHODS This is a planned secondary analysis of data from the CRADLE-3 trial from ten clusters across Africa, India and Haiti where the device and training package were randomly introduced. Referral data were prospectively collected for a 4-week period before, and a 4-week period 3 months after implementation. Referrals from primary or secondary care facilities to higher level care for any cause were recorded. The denominator was the number of women seen for maternity care in these facilities. RESULTS Between April 1 2016 and Nov 30th, 2017 536,223 women attended maternity care facilities. Overall, 3.7% (n = 2784/74,828) of women seen in peripheral maternity facilities were referred to higher level care in the control period compared to 4.4% (n = 3212/73,371) in the intervention period (OR 0.89; 0.39-2.05) (data for nine sites that were able to collect denominator). Of these 0.29% (n = 212) pre-intervention and 0.16% (n = 120) post-intervention were referred to higher-level facilities for maternal haemorrhage. Although overall referrals did not significantly reduce there was a significant reduction in referrals for obstetric haemorrhage (OR 0.56 (0.39-0.65) following introduction of the device with homogeneity (i-squared 26.1) between sites. There was no increase in any bleeding-related morbidity (maternal death or emergency hysterectomy). CONCLUSIONS Referrals for obstetric haemorrhage reduced following implementation of the CRADLE Vital Signs Alert Device, occurring without an increase in maternal death or emergency hysterectomy. This demonstrates the potential benefit of shock index in management pathways for obstetric haemorrhage and targeting limited resources in low- middle- income settings. TRIAL REGISTRATION This study is registered with the ISRCTN registry, number ISRCTN41244132 (02/02/2016).
Maternal characteristics and causes associated with refractory postpartum haemorrhage after vaginal birth: a secondary analysis of the WHO CHAMPION trial data
BJOG : an international journal of obstetrics and gynaecology. 2019
OBJECTIVE To assess the maternal characteristics and causes associated with refractory postpartum haemorrhage (PPH). DESIGN Secondary analysis of the WHO CHAMPION trial data. SETTING 23 hospitals in 10 countries. POPULATION Women from the CHAMPION trial who received uterotonics as first line treatment of PPH. METHODS We assessed the association between socio-demographic, pregnancy and childbirth factors and refractory PPH, and compared the causes of PPH between women with refractory PPH, and women responsive to first-line PPH treatment. MAIN OUTCOME MEASURES Maternal characteristics; causes of PPH RESULTS Women with labour induced or augmented with uterotonics (aOR 1.35; 95% CI 1.07 - 1.72), with episiotomy or tears requiring suturing (aOR 1.82; 95% CI 1.34 - 2.48), and who had babies with birthweights ≥ 3500 g (aOR 1.33; 95% CI 1.04 - 1.69), showed significantly higher odds of refractory PPH compared to the reference categories in the multivariate analysis adjusted by center and trial arm. While atony was the sole PPH cause in 53.2% (116/218) of the women in the responsive PPH group, it accounted for only 31.5% (45/143) of the causes in the refractory PPH group. Conversely, tears were the sole cause in 12.8% (28/218) and 28% (40/143) of the responsive PPH and refractory PPH groups respectively. Placental problems were the sole cause in 11% and 5.6% in the responsive and refractory PPH groups respectively. CONCLUSION Women with refractory PPH showed a different pattern of maternal characteristics and PPH causes compared to those with first-line treatment responsive PPH.