Midwifery Clinical Trial
Official title:
MIDWIZE - Strengthening Midwives to Implement and Sustain Quality Improvements to Optimise Maternity Care: A Longitudinal Observational Study in Uganda
NCT number | NCT05237375 |
Other study ID # | MIDWIZE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 10, 2022 |
Est. completion date | September 1, 2025 |
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | September 1, 2025 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: People above the age of 18 with uncomplicated singleton full-term pregnancies and births (i.e. between weeks 37 + 0 - 42 + 0). Exclusion Criteria: People under the age of 18, people with complications in pregnancy or with a planned c-section. |
Country | Name | City | State |
---|---|---|---|
Uganda | CUFH Naguru | Kampala | Naguru |
Uganda | Kawalla Hospital | Kampala | |
Uganda | Kawempe Hospital | Kampala | |
Uganda | Kisenye Hospital | Kampala |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | The Swedish Institute |
Uganda,
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. — View Citation
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: 10.1080/16549716.20 — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Mothers age | 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. | |
Secondary | Level of education | Level of education for mothers giving birth during the intervention. | 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 | Marital status | 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. | |
Secondary | Area of living | 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. | |
Secondary | Employment | 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. | |
Secondary | Obstetric background | Obstetric background | Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed.6months after implementation phase is completed. | |
Secondary | Gestation week | Gestation week | 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 | Mode of delivery | Mode of delivery | 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 | Length of second stage of labour | Length of second stage of labour | 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 | Birth weight | Birth weight | 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 | Transfer to a neonatal unit | Transfer to a neonatal unit | 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 | Skin-to-skin care | the number of minutes of skin-to-skin observed and documented by a Research Assisatant. Maximum observation time is 1hour. | Through study completion, an average of 6 months and a follow up period (2 weeks) after 3 and 6months after implementation phase is completed. |
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