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Effectiveness of a Midwife Led Continuity of Antenatal care caseload model on preterm birth and maternal satisfaction among women in Malawi

Effectiveness of a Midwife Led Continuity of Antenatal care caseload model on preterm birth and maternal satisfaction among women in Malawi: A randomised clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000008820
Acronym
EMiLCA
Enrollment
1131
Registered
2021-01-08
Start date
2021-06-01
Completion date
2022-12-30
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Worldwide, maternal and neonatal morbidity and mortality remain a public health concern and improving maternal and neonatal health is a key focus in most countries. Similar to other countries in sub-Saharan Africa, Malawi has high maternal and neonatal mortality ratios with preterm birth being the leading cause of deaths among neonates. In addition, there is underutilization of antenatal care services, a factor known to increase risk for adverse childbirth outcomes. Statistics for Malawi show that of the 95% women who attend at least one antenatal contact, only 51% attend four or more contacts, and only 24% attend the initial antenatal contact during the first trimester of pregnancy. The antenatal period provides a first entry point within the childbirth continuum to implement effective interventions aimed at improving maternal and neonatal health, through prevention, detection and management of obstetric complications. The under-utilization of antenatal care services puts women at increased risk of adverse outcomes such as preterm births. The World Health Organisation recommends use of Midwife Led Continuity of Care (MLCC) models during pregnancy that has been associated with improved antenatal care utilization and childbirth outcomes. In MLCC models women receive care from the same caregiver (caseload) or a small group of midwives (team) during the childbirth continuum. Antenatal care in Malawi is based on a fragmented standard antenatal care (SANC) model with care provision from different midwives and doctors resulting in minimal continuity of care. This study aims to examine whether caseload model decreases rate of preterm births among women when compared with SANC model. The study will also compare other outcomes such as antenatal attendance, admission to antenatal ward, satisfaction with care, place of birth, labour onset, mode of birth, anaemia, malaria, antepartum haemorrhage, postpartum haemorrhage, hypertensive disorders of pregnancy, birth weight, Apgar score, admission to neonatal nursery ward, initiation of breast feeding, initiation of skin-to-skin contact, fetal and neonatal loss.

Interventions

MIDWIFE LED CONTINUITY OF ANTENATAL CARE CASELOAD MODEL (INTERVENTION) The study intervention is midwife led continuity of antenatal care caseload model. Pregnant women allocated to the midwife led continuity of antenatal care caseload model will receive antenatal care from a known primary midwife from their first antenatal care contact to their last antenatal care contact. The women will have a minimum of eight scheduled individual antenatal care contacts with their primary midwife, who will pr

MIDWIFE LED CONTINUITY OF ANTENATAL CARE CASELOAD MODEL (INTERVENTION) The study intervention is midwife led continuity of antenatal care caseload model. Pregnant women allocated to the midwife led continuity of antenatal care caseload model will receive antenatal care from a known primary midwife from their first antenatal care contact to their last antenatal care contact. The women will have a minimum of eight scheduled individual antenatal care contacts with their primary midwife, who will provide 30-minute appointments for each scheduled contact. The antenatal care (assessments, care and health information) will be provided using the current Malawi antenatal care guidelines and matrix, which stipulate that each woman should attend a minimum of eight antenatal care contacts as follows: 1st contact up to 12 weeks; 2nd contact at 20 weeks; 3rd contact at 26 weeks; 4th contact at 30 weeks; 5th contact at 34 weeks; 6th contact at 36 weeks, 7th contact at 38 weeks and 8th contact at 40 weeks gestation. Within each antenatal care contact the primary midwife will conduct maternal and fetal assessments, provide care on prevention of malaria, anaemia and infection, and health information on diet, exercise, contraception, birth preparedness, breastfeeding and danger sign to each woman, which will provide women with increased information and knowledge through longer antenatal appointments with a known primary midwife. If a woman develops any complication, she will be referred to a medical doctor for further management and the primary midwife will continue to provide antenatal care in addition to the medical or obstetric care. Women allocated to the caseload model will be encouraged to contact their primary midwife by mobile phone when they have questions, concerns or need further clarification. STAFFING OF MIDWIVES TO MIDWIFE LED CONTINUITY OF ANTENATAL CARE CASELOAD MODEL In order to staff the study intervention, a total of six primary midwives will be employed to provide antenatal care to approximately 603 women allocated to the caseload model, 100 women each, and they will work up to 40 hours per week, Monday to Friday on shifts as previously arranged in accordance with the schedule of his/her individual woman. The primary midwives will be paired to provide backup should the other midwife be absent, and the backup midwife will be introduced to women of the other midwife within the first three antenatal care contacts. To be eligible to work in the caseload model, the midwife must be registered with Nurses and Midwives Council of Malawi, have a minimum of one-year work experience in a maternity setting and demonstrate interest in caseload model. The midwives will continue to work under the professional supervision of the hospital matrons and the District Nursing and Midwifery Officer of Mchinji District Hospital, Malawi. ADHERENCE TO STUDY PROTOCOLS AND INTERVENTION EVALUATION Two weeks before commencement of the study, all midwives working at the antenatal clinic of Mchinji District Hospital, Malawi will undergo a one-day training where they will be re-oriented to Malawi guidelines for providing antenatal care and the study protocols. The primary midwives will have an additional one-day training where they will be oriented to principles behind caseload model. Three facilitators, the researcher (BDZ), matron of the antenatal clinic and an officer from Quality Assurance Directorate of Malawi will train the midwives using study specific training material and current Malawi antenatal care guidelines. Adherence to guidelines for the caseload model will be ascertained through monthly meetings between the research team, hospital matrons, primary midwives and officers from Quality Assurance Directorate of Malawi who conduct monthly supervision of government hospitals in Malawi. At the final monthly meeting, questions on compliance to study interventions will be asked to primary midwives to ascertain whether study implementation guidelines were adhered to. In addition, there will be weekly checks of data entered in the electronic database to assess adherence to data entry guidelines. Women’s exposure to the caseload model will be measured by checking quality and quantity of data on care provision captured in the maternity record books. In addition, a survey with women at the last antenatal care contact will include questions on model of care to check if they had a known primary midwife and the number of antenatal care contacts they had with the midwife/midwives.

Sponsors

Barbara Debra Zileni
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pregnant women aged 18 years and above; Able to speak the local language Chichewa; Planning to give birth at the study site; Commencing initial antenatal care at a gestation of below 20 weeks

Exclusion criteria

Pregnant women younger than 18 years; Not able to speak Chichewa; Not planning to give birth at the study site; Initiating first antenatal care contact at a gestation of 20 weeks and above; History of one or more caesarean births; Medical and obstetric complications such as severe anaemia, cardiac disease, chronic hypertension, type 1 diabetes mellitus, multiple pregnancy and planned caesarean birth.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026