TABLE 6.

Overview of Implementation Outcomes Across Observations, Interviews, Audit of Drug Use and Assessment of Implementation Outcomes

Implementation OutcomeObservationsa(18 observations of vaginal birth, 7 PPHs)Interviews (n=58)Overall Assessment of Implementation Outcomesb
Fidelity
Calibrated drape
  • Time of placing the calibrated drape: After birth and before oxytocin for PPH prevention (n=12/18); before birth with funnel rolled up (n=5/18), (1 calibrated drape in South Africa was placed after birth and after oxytocin for PPH prevention).

  • Who placed the drape: midwife conducting the birth (n=11/18) includes 1 student midwife, E-MOTIVE research midwife (n=7/18). The calibrated drape was placed by the E-MOTIVE research midwife in Kenya n=2/7 and Nigeria n=5/7.

  • Checking of blood loss calibration lines: Read for 14/18 births, although position of drape varied (e.g., hanging over bed or flat on bed).

  • Blood swept into funnel of drape: Kenya (n=2/7), Nigeria (n=7/7), South Africa (n=4/4).

  • Blood swept from under the woman:

    • Kenya (n=2/7 drape removal, n=5/7 not done).

    • Nigeria (n=2/7 after birth, n=2/7 after placenta delivery n=1/7 drape removal, n=2/7 not reported).

    • South Africa (n=1/4 after examination and suturing, n=1/4 after placenta and suturing, n=1/4 drape removal, n=1/4 once without timing).

  • Time in place: Kenya (median: 34 min, range: 8–52 min); Nigeria (median: 63 min, range: 22–94 min); South Africa (median: 65 min, range: 57–74 min).

  • Vital signs measured while drape on: Kenya (n=1/7), Nigeria (n=2/7), South Africa (n=7/7).

All participants reported always using the calibrated drape to detect PPH.

(Noted: discrepancy between self-reported and observed practice).

Use of drape: Medium to high fidelity

Placing of drape by regular staff not employed by E-MOTIVE:

Low to medium

fidelity

MOTIVE components
  • MOTIVE triggered at: blood loss ≥ 500 ml: n=4/7; ≥300 ml + abnormal clinical signs n=1/7; placenta took 15 minutes to deliver n=1/7; not recorded n=1/7.

  • Time between birth and triggering MOTIVE: median=12 minutes (range 5–30 minutes).

  • Administering of MOTIVE components:

    • Massage n=7/7.

    • Oxytocin infusion n=7/7.

    • Other uterotonics (misoprostol n=4/7).

    • Tranexamic acid n=7/7.

    • IV fluid n=7/7.

  • Facility-based CRFs (% increase in brackets: difference between baseline and pilot).c

  • Use of oxytocin (%).

  • Kenya 83%, (+14%); Nigeria 95%, (+30%); South Africa 80%, (+33%); Tanzania 100%, (0%).

  • Overall increase, 34%.

  • Use of tranexamic acid.

  • Kenya 83%, (+47%); Nigeria 90%, (+86%); South Africa 68% (+43%); Tanzania 100%, (+50%).

  • Overall increase, 59%.

  • All participants said, they administered all MOTIVE components of the bundle in quick succession to manage PPH.

  • Participants said, they did not wait to see if one treatment worked before giving another treatment.

Use of MOTIVE:

High fidelity

Training
  • Dedicated space for skills sessions and PPH simulation.

  • 22 simulations took place across countries.

  • Staff (typically nurses and midwives) participated in 2–7 simulation sessions.

  • Across all countries, all participants reported receiving initial training by an on-site trainer.

  • There were mixed responses about attending follow-up skills sessions and PPH simulation.

  • Across all countries some participants said they have not taken part in any practice drill sessions (n=19).

Initial training: High fidelityFollow-up skills sessions and PPH simulation:Low to mediumfidelity

PPH trolley/carry case

  • PPH trolley taken to bedside n=1/7.

  • All sites had an accessible PPH trolley which was checked either daily, weekly, or at beginning/end of shift and regularly restocked.

  • Most likely checked by an E-MOTIVE research midwife instead of on-site staff.

  • Substantial variation in the supplies kept in the PPH trolley especially in Kenya and Nigeria.

  • CRADLE devices (to take vital signs) supplied by E-MOTIVE project were often missing.

  • All countries kept oxytocin in fridges (as per local protocol).

All participants said there was a PPH trolley available on the labor ward; however, some participants said it was not always used.

Availability of trolley:High fidelityUse of trolley:Low fidelity

ChampionsNANumber of participants reporting champions at site and number of champions in situ (if known) were:
  • Kenya (n=13); 1–3 champions/sites (doctors and nurses).

  • Nigeria (n=12); 2 champions/site (doctors and nurses).

  • South Africa (n=9): 1–2 champions /site (doctors and nurses).

  • Tanzania (n=10); 1–2 champions/site (doctors and nurses).

Champions in place:High fidelity

Audit and feedbackNA
  • Participants, who were aware of audit and feedback (n=12/58).

  • Not all participants were receiving audit/feedback (n=8/58); none in South Africa.

  • Participants reported, consultants and doctors are more likely to receive feedback (n=5/58): in Nigeria and South Africa.

  • Format is verbal and/or graphs (n=5), in Kenya and Tanzania.

  • E-MOTIVE staff (i.e., research midwife, champion, or on-site trainer) deliver audit/feedback to staff (n=5) in Kenya and Tanzania.

Engagement with audit and feedback:Low fidelity

Acceptability
Calibrated Drape and MOTIVE componentsNAAcross all countries, participants were satisfied with using the calibrated drape to detect PPH and using the MOTIVE components to treat PPH.High acceptability
Training, PPH trolley/carry case, champions and audit and feedbackNAAcross all countries, participants said the implementation strategies offered appropriate support and encouragement to improve uptake of the E-MOTIVE intervention and implementation strategies at their site.High acceptability
Feasibility
E-MOTIVE Intervention and implementation strategiesPractical use of the E-MOTIVE intervention, attending the training by nursing staff and using PPH trolley/carry case was demonstrated at all sites.Across all countries, participants reported it was feasible to deliver the bundle and engage with the implementation strategies.High feasibility
  • Abbreviations: CRF, case report form; NA, not assessed via observations; E-MOTIVE, early detection of postpartum hemorrhage, massage of uterus, oxytocic drugs administration, tranexamic acid administration, intravenous fluids administration, examination for identifying and managing the source of bleeding, and escalation to more advanced care, if bleeding continues despite treatment; PPH, postpartum hemorrhage.

  • a No observation completed in Tanzania (fidelity of E-MOTIVE intervention use).

  • b Assessment of implementation outcomes (fidelity, feasibility, acceptability) criteria: low=≤50%; medium=between 51%–79% and high ≥80%.

  • c Data collected by University of Birmingham clinical trial team.