Trial Outcomes & Findings for A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth (NCT NCT04341662)

NCT ID: NCT04341662

Last Updated: 2025-04-18

Results Overview

1. Number of women with primary severe PPH defined as blood loss ≥1000 ml following a vaginal birth in the facility up to 2 hours postpartum 2. Number of women with postpartum laparotomy for bleeding until discharge from the health facility 3. Number of postpartum maternal deaths from bleeding until discharge from the health facility. A Blinded Endpoint Review Committee (BERC) will assess incoming data relevant to the primary outcome in order to confirm if any postpartum laparotomy was performed for bleeding and if any maternal death was due to bleeding

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99659 participants
• Primary outcome timeframe: Postpartum until discharge from the health facility (up to 42 days)
• Results posted on: 2025-04-18

Participant Flow

Women were excluded from the final analysis if their blood loss data could not be source-verified with photographic evidence of the blood collection drape on the weighing scales (displaying the drape weight) which could be linked to the patient I.D number

Participant milestones

Measure	E-MOTIVE Intervention The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Overall Study STARTED	49101	50558
Overall Study COMPLETED	48678	50044
Overall Study NOT COMPLETED	423	514

Reasons for withdrawal

Measure	E-MOTIVE Intervention The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Overall Study Did not have source-verified blood loss data	423	514

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.	Total n=99659 Participants Total of all reporting groups
Age, Continuous	26 years n=49101 Participants	26 years n=50558 Participants	26 years n=99659 Participants
Sex: Female, Male Female	49101 Participants n=49101 Participants	50558 Participants n=50558 Participants	99659 Participants n=99659 Participants
Sex: Female, Male Male	0 Participants n=49101 Participants	0 Participants n=50558 Participants	0 Participants n=99659 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Tanzania	10658 participants n=49101 Participants	10627 participants n=50558 Participants	21285 participants n=99659 Participants
Region of Enrollment South Africa	9668 participants n=49101 Participants	9030 participants n=50558 Participants	18698 participants n=99659 Participants
Region of Enrollment Kenya	11475 participants n=49101 Participants	9992 participants n=50558 Participants	21467 participants n=99659 Participants
Region of Enrollment Nigeria	17300 participants n=49101 Participants	20909 participants n=50558 Participants	38209 participants n=99659 Participants

PRIMARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days)

Population: Number of women

1. Number of women with primary severe PPH defined as blood loss ≥1000 ml following a vaginal birth in the facility up to 2 hours postpartum

2. Number of women with postpartum laparotomy for bleeding until discharge from the health facility

3. Number of postpartum maternal deaths from bleeding until discharge from the health facility.

A Blinded Endpoint Review Committee (BERC) will assess incoming data relevant to the primary outcome in order to confirm if any postpartum laparotomy was performed for bleeding and if any maternal death was due to bleeding

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
The Primary Outcome is a Composite of the Following Three Clinical Outcomes: 1) Severe PPH Defined as Blood Loss ≥1000 ml or; 2) Postpartum Laparotomy for Bleeding or; 3) Postpartum Maternal Death From Bleeding. Please See Below for Further Details.	794 Participants	2139 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

With the following numerator and denominator: women who objectively had PPH (source-verified blood loss ≥ 500 mL after weighing of the drape) and were diagnosed with PPH by the birth attendants divided by the total number of women who objectively had PPH (source verified blood loss ≥ 500 mL after weighing the drape)

Outcome measures

Measure	E-MOTIVE Intervention n=4158 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=8351 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
PPH Detection	3,870 Participants	4,244 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Defined as adherence with three core elements of the bundle: administration of oxytocic drugs, TXA and IV fluids. If all three core elements are administered when a PPH is diagnosed, this will be deemed positive for bundle compliance

Outcome measures

Measure	E-MOTIVE Intervention n=4158 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=8351 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Compliance With MOTIVE Bundle	3791 Participants	1623 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days)

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women With Laparotomy Postpartum Until Discharge From the Health Facility	13 Participants	9 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women With Laparotomy With Compression Sutures Postpartum Until Discharge From the Health Facility	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the healthcare facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women With Laparotomy With Arterial Ligation Postpartum Until Discharge From the Health Facility	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women With Hysterectomy Postpartum Until Discharge From the Health Facility	11 Participants	6 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women With Hysterectomy for Bleeding Postpartum Until Discharge From the Health Facility	9 Participants	6 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Rate of All Cause Maternal Mortality Postpartum Until Discharge From the Health Facility	17 Participants	28 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Reported in millilitres

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Amount of Blood Loss (as a Continuous Variable)	160 Millilitres Interval 100.0 to 280.0	220 Millilitres Interval 120.0 to 380.0

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Measured in mililitres

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women With Primary PPH Defined as Blood Loss ≥500 ml	4,158 Participants	8,351 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Measured in days

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Duration of Hospitalisation Postpartum	1 Days Interval 0.0 to 1.0	1 Days Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Measured in days

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Duration of ICU Hospitalisation Postpartum	1 Days Interval 0.0 to 3.0	1 Days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Transferred to a Higher-level Facility Postpartum Until Discharge From the Health Facility	85 Participants	18 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49923 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=51535 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Rate of All Cause Neonatal Mortality Postpartum Until Discharge From the Health Facility	2259 Participants	2233 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving Non-pneumatic Anti-shock Garment (NASG) Postpartum Until Discharge From the Health Facility	90 Participants	38 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving Uterine Balloon Tamponade Postpartum Until Discharge From the Health Facility	44 Participants	57 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving a Blood Transfusion Postpartum Until Discharge From the Health Facility	1074 Participants	1296 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving Blood Transfusion for Postpartum Haemorrhage Until Discharge From the Health Facility	580 Participants	944 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Admitted to Intensive Care Unit (ICU) Until Discharge From the Health Facility	7 Participants	32 Participants

SECONDARY outcome

Timeframe: Up to 2 hours postpartum

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women With Primary Severe PPH (Defined as Blood Loss ≥1000 ml) Following a Vaginal Birth in the Facility Measured up to 2 Hours Postpartum	786 Participants	2,129 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Postpartum Laparotomy for Bleeding Until Discharge From the Health Facility	12 Participants	7 Participants

SECONDARY outcome

Timeframe: Postpartum until discharge from the health facility (up to 42 days).

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Postpartum Maternal Death From Bleeding Until Discharge From the Health Facility	12 Participants	18 Participants

SECONDARY outcome

Timeframe: Up to 2 hours postpartum (or up to 24 hours if bleeding continues)

Population: Number of women

With the following numerator and denominator: women diagnosed with PPH by the birth attendants divided by the total of women having a vaginal birth in the health facility

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
PPH Treatment by Healthcare Provider up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)	5921 Participants	4899 Participants

SECONDARY outcome

Timeframe: Up to 2 hours postpartum (or up to 24 hours if bleeding continues)

Population: Number of women

With the following numerator and denominator: women treated with the PPH bundle following a diagnosis of PPH by the birth attendants divided by the total of women having a vaginal birth in the health facility

Outcome measures

Measure	E-MOTIVE Intervention n=49101 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Bundle Usage up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)	5,783 Participants	1,725 Participants

SECONDARY outcome

Timeframe: Up to 2 hours postpartum (or up to 24 hours if bleeding continues)

Population: Number of women

With the following numerator and denominator: women treated with the PPH bundle following a diagnosis of PPH by the birth attendant divided by the total of women diagnosed with PPH by the birth attendants

Outcome measures

Measure	E-MOTIVE Intervention n=5921 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=4899 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Bundle Usage for PPH up to 2 Hours Postpartum (or up to 24 Hours if Bleeding Continues)	5783 Participants	1725 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=5921 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=4899 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving Uterine Massage for PPH	5794 Participants	4119 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=5921 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=4899 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving Oxytocin for PPH	5897 Participants	4321 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=5921 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=4899 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving Misoprostol for PPH	2601 Participants	2732 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=5921 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=4899 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving TXA for PPH	5829 Participants	1983 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=5921 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=4899 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving Intravenous Fluids (IV) for PPH	5884 Participants	4199 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Physical observation (no specific tool used).

Outcome measures

Measure	E-MOTIVE Intervention n=5921 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=4899 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving Examination of the Genital Tract	5506 Participants	3608 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=5921 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=4899 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Receiving Any Treatment Uterotonic for PPH	5909 Participants	4541 Participants

SECONDARY outcome

Timeframe: Up to 24 hours postpartum

Population: Number of women

Outcome measures

Measure	E-MOTIVE Intervention n=5921 Participants The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=4899 Participants Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Number of Women Requiring Additional Treatment Interventions (Not Responding to the MOTIVE Bundle).	219 Participants	637 Participants

Adverse Events

E-MOTIVE Intervention

Serious events: 7 serious events

Other events: 0 other events

Deaths: 17 deaths

Usual Care

Serious events: 32 serious events

Other events: 0 other events

Deaths: 28 deaths

Serious adverse events

Measure	E-MOTIVE Intervention n=49101 participants at risk The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called "MOTIVE", based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination \& Escalation; and 3) an implementation strategy, focusing on simulation-based training with peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with trigger line, and MOTIVE emergency trolley and/or carry case.	Usual Care n=50558 participants at risk Usual care with dissemination of the current guidelines Usual care: Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
Pregnancy, puerperium and perinatal conditions Admission to ICU	0.01% 7/49101 • As the interventions being tested as a bundle in this trial are recommended and used throughout the world, there are no adverse events which would be anticipated as a unique consequence of participation in the trial. No expedited reporting of adverse events is proposed. Maternal deaths and ICU admissions were collected until discharge from the health facility (up to 42 days)	0.06% 32/50558 • As the interventions being tested as a bundle in this trial are recommended and used throughout the world, there are no adverse events which would be anticipated as a unique consequence of participation in the trial. No expedited reporting of adverse events is proposed. Maternal deaths and ICU admissions were collected until discharge from the health facility (up to 42 days)

Other adverse events

Adverse event data not reported

Additional Information

Dr Adam Devall

University of Birmingham

Phone: +447971823452

Email: a.j.devall@bham.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place