MIDWIZE - Strengthening Midwives

NCT05237375 | Recruiting

• 1 other identifier: MIDWIZE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief Summary

This PhD project aims to explore how midwives can take the lead in implementing and enhancing evidence-based quality improvement (QI) components within maternal and newborn health care in Uganda. The MIDWIZE conceptual framework will be used to understand the complexity of sustainably enhancing maternal and newborn healthcare. The project will start with a multisectoral co-creation process and subsequently involve online and onsite capacity building for midwives on selected evidence-based practices and implementation strategies. The project applies a mixed-method research approach, including focus groups discussions, interviews, quantitative data on health outcomes and a tool evaluating midwives' sense of power and autonomy.

Conditions

Midwifery

Keywords

Midwifery, Midwife Led Care, MIDWIZE

Outcome Measures

Primary Outcomes (6)

• The uptake of the midwives quality improvments

  Three evidence based midiwfery practises (i) dynamic birth positions, (ii) intrapartum support and (iii) prevetion of perineal tears .

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

• Apgar score

  Apgar score. The Apgar score is a rapid assessment of a newborn's health, conducted one minute and five minutes after birth, evaluating their heart rate, respiratory effort, muscle tone, reflex irritability, and color. Each component is scored from 0 to 2 points, with a maximum score of 10 points.

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

• Perineal tear

  Perineal tear (divided in unsutured tear, sutured tear, sphinkter tear)

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

• Episiotomy

  Was episiotomy performed at birth

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

• Postpartum haemorrhage

  Postpartum haemorrhage

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

• Neonatal and maternal deaths

  Neonatal and maternal deaths

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

Secondary Outcomes (12)

• Mothers age

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

• Level of education

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

• Marital status

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

• Area of living

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

• Employment

  Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.

Study Arms (3)

The MIDWIZE model

Pregnant women giving birth during at Naguru maternity ward during the intervention period It's only Sub/study 2 in this PhD project which is a clinical trial and which is described onwards. Sub-study 2 will include all women above the age of 18 with uncomplicated full-term pregnancies and births (i.e. between weeks 37 + 0 - 42 + 0) giving birth at the delivery ward during the implementation phase. Data will be collected during the implementation of the quality improvement components.

Other: The MIDWIZE model

The MIDWIZE model - postintervention

Pregnant women giving birth at Naguru maternity ward 3 and 6 months post intervention period. Sub-study 2 will include all women above the age of 18 with uncomplicated full-term pregnancies and births (i.e. between weeks 37 + 0 - 42 + 0) giving birth at the delivery ward 3 and 6 months after the implementation phase. Data will be collected after implementing the quality improvement components. The post-measurement data will be collected on the chosen components six months after project implementation to measure if the midwife-led quality improvement project has been sustained.

The MIDWIZE model - scaling up

The intervention will be scaled up at three additional sites and will include all women above the age of 18 with uncomplicated full-term pregnancies and births (i.e., between weeks 37 + 0 - 42 + 0) giving birth at the delivery ward during the implementation phase.

Interventions

The MIDWIZE model OTHER

So-called "MIDWIZE ambassadors" are planned to be appointed to lead the clinical implementation of the quality improvement components. Initial training workshops will be held with the ambassadors on practical aspects of the chosen components and how to explain their benefits to the units' staff. Training will also be provided on how to enhance interdisciplinary teamwork and coordinate quality improvements. The workshops will be held onsite at Naguru hospital and online via the project's "MIDWIZE virtual platform". The ambassadors will themselves hold training workshops to support midwives and other healthcare providers at the clinics during the implementation of the quality improvements components. The virtual MIDWIZE platform will contain videos, posters, presentations, and other training material that the ambassadors can utilise to enhance the units' capacity and engage their colleagues.

The MIDWIZE model

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women coming to give birth at Naguru Hospital during or after the implementation of the MIDWIZE model.

You may qualify if:

• People above the age of 18 with uncomplicated singleton full-term pregnancies and births (i.e. between weeks 37 + 0 - 42 + 0).

You may not qualify if:

• People under the age of 18, people with complications in pregnancy or with a planned c-section.

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Institute: collaborator

Study Sites (4)

CUFH Naguru

Kampala, Naguru, Uganda

COMPLETED

Kawalla Hospital

Kampala, Uganda

RECRUITING

Kawempe Hospital

Kampala, Uganda

RECRUITING

Kisenye Hospital

Kampala, Uganda

RECRUITING

Related Publications (5)

• Berta M, Lindgren H, Christensson K, Mekonnen S, Adefris M. Effect of maternal birth positions on duration of second stage of labor: systematic review and meta-analysis. BMC Pregnancy Childbirth. 2019 Dec 4;19(1):466. doi: 10.1186/s12884-019-2620-0.

  PMID: 31801479 BACKGROUND

• Hailemeskel S, Alemu K, Christensson K, Tesfahun E, Lindgren H. Health care providers' perceptions and experiences related to Midwife-led continuity of care-A qualitative study. PLoS One. 2021 Oct 14;16(10):e0258248. doi: 10.1371/journal.pone.0258248. eCollection 2021.

  PMID: 34648571 BACKGROUND

• Nove A, Friberg IK, de Bernis L, McConville F, Moran AC, Najjemba M, Ten Hoope-Bender P, Tracy S, Homer CSE. Potential impact of midwives in preventing and reducing maternal and neonatal mortality and stillbirths: a Lives Saved Tool modelling study. Lancet Glob Health. 2021 Jan;9(1):e24-e32. doi: 10.1016/S2214-109X(20)30397-1. Epub 2020 Dec 1.

  PMID: 33275948 BACKGROUND

• Blomgren J, Wells MB, Erlandsson K, Amongin D, Kabiri L, Lindgren H. Putting co-creation into practice: lessons learned from developing a midwife-led quality improvement intervention. Glob Health Action. 2023 Dec 31;16(1):2275866. doi: 10.1080/16549716.2023.2275866. Epub 2023 Nov 6.

  PMID: 37930253 RESULT

• Blomgren J, Wells MB, Amongin D, Erlandsson K, Wanyama J, Afrifa DA, Lindgren H. Improving apgar scores and reducing perineal injuries through midwife-led quality improvements: an observational study in Uganda. BMC Public Health. 2025 Jan 3;25(1):19. doi: 10.1186/s12889-024-21137-w.

  PMID: 39754106 DERIVED

Study Officials

• Helena Lindgren, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Lindgren

CONTACT

0733442599; helena.lindgren@ki.se

Johanna Blomgren

CONTACT

+46708747577; johanna.blomgren@ki.se

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: February 14, 2022
• Study Start: March 10, 2022
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (4)