Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000008820
Ethics application status
Approved
Date submitted
28/10/2020
Date registered
8/01/2021
Date last updated
29/11/2022
Date data sharing statement initially provided
8/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Midwife Led Continuity of Antenatal care caseload model on preterm birth and maternal satisfaction among women in Malawi
Scientific title
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
Secondary ID [1] 302545 0
Nil Known
Universal Trial Number (UTN)
U1111-1259-6939
Trial acronym
EMiLCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm birth 319520 0
Condition category
Condition code
Reproductive Health and Childbirth 317389 317389 0 0
Antenatal care
Public Health 317816 317816 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318833 0
Treatment: Other
Intervention code [2] 318834 0
Prevention
Comparator / control treatment
STANDARD ANTENATAL CARE MODEL (COMPARISON GROUP)
Pregnant women allocated to the standard antenatal care model will receive care from different midwives rostered for duty on each day. Any of the eight midwives currently working at the antenatal clinic of Mchinji District hospital will provide care to women allocated to the standard antenatal care model and there will be no consistency of the midwives attending to women at each of the eight appointments as the midwives will vary between appointments. Care provision will be done following the Malawi antenatal care guidelines and schedule.
As with the intervention group, care provision to each woman allocated to the standard antenatal care model will include 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. If a woman develops any complication, she will be referred to a doctor for further management and will continue to be a study participant receiving antenatal care from different midwives and doctors in standard antenatal care model in addition to the medical or obstetric care.
Control group
Active

Outcomes
Primary outcome [1] 325469 0
Proportion of participants with a preterm birth (<37 weeks gestation) data derived from medical and maternity records (birth register book).
Timepoint [1] 325469 0
At birth
Primary outcome [2] 325470 0
Proportion of women with a satisfaction of antenatal care score of 6 and above. Data derived from a questionnaire named: "End-line survey on satisfaction with antenatal care". The survey questionnaire has been adapted from a previously validated survey tool from studies on midwife led continuity of care models conducted in Australia, COSMOS randomised controlled trial by Forster et al., 2016 and Palestine by Mortensen, Lieng, et al., 2019.
Timepoint [2] 325470 0
At the last antenatal care contact
Secondary outcome [1] 388128 0
Total number of antenatal care contacts. Data derived from antenatal care register book and women's hand held antenatal book.
Timepoint [1] 388128 0
At the last antenatal care contact
Secondary outcome [2] 388129 0
Anaemia in pregnancy which will be assessed by measuring the haemoglobin level (Hb) using a haemoglobinometer test (HemoCue) and categorised as sever anaemia (Hb is <6.9g/dl), moderate anaemia (Hb is 7-9.9g/dl) and mild anaemia (Hb is 10-11g/dl) (WHO diagnosis of anaemia and assessment of severity).
Data derived from the recorded haemoglobin level in the antenatal care register book and women's hand held antenatal book.
Timepoint [2] 388129 0
At baseline and at sixth antenatal care contact
Secondary outcome [3] 388130 0
Malaria in pregnancy, data derived from antenatal care register book and women's hand held antenatal book.
Timepoint [3] 388130 0
At the last antenatal care contact
Secondary outcome [4] 388131 0
Antepartum haemorrhage, data derived from the recorded diagnosis of antepartum haemorrhage in the medical and maternity records (birth register book).
Timepoint [4] 388131 0
At birth
Secondary outcome [5] 388181 0
Postpartum haemorrhage, data derived from the recorded diagnosis of postpartum haemorrhage in the medical and maternity records (birth register book).
Timepoint [5] 388181 0
At birth
Secondary outcome [6] 388182 0
Hypertensive disorder of pregnancy which will be assessed by measuring presence of elevated blood pressure, protein in urine (proteinuria) and/or convulsion during pregnancy and after childbirth. Proteinuria will be assessed by measuring presence of protein in urine using urine dipstick.
Hypertensive disorders of pregnancy will be categorised as:
• Chronic hypertension if a woman has elevated blood pressure of more than 140/90mmHg on two consecutive readings taken 4 hours apart before 20 weeks gestation
• Gestational hypertension if a woman has systolic blood pressure (SBP) range of 140 to <160mmHg and diastolic blood pressure (DBP) range of 90 to <110mmHg) on two consecutive readings taken 4 hours apart after 20 weeks gestation with no proteinuria
• Mild pre-eclampsia if a woman has SBP range of 140 to <160mmHg and DBP range of 90 to <110mmHg) on two consecutive readings taken 4 hours apart after 20 weeks gestation with proteinuria of 2+
• Severe pre-eclampsia if a woman has systolic blood SBP of >160mmHg and DBP of >110mmHg) after 20 weeks gestation with proteinuria of 2+
• Eclampsia if a woman has SBP of >140 and DBP of >90 after 20 weeks gestation and convulsions
Data will be derived from medical and maternity records (birth register book).
Timepoint [6] 388182 0
At birth
Secondary outcome [7] 388185 0
Admission to high risk antenatal ward, data derived from medical and maternity records (antenatal admission book).
Timepoint [7] 388185 0
At birth
Secondary outcome [8] 388186 0
Place of birth (hospital, health centre, home, birth before arrival, traditional birth attendant), data derived from women's hand-held maternity care book and birth register book.
Timepoint [8] 388186 0
At birth and at one week postnatal check-up
Secondary outcome [9] 388187 0
Onset of labour (spontaneous, induced, augmented), data derived from medical and maternity records (birth register book).
Timepoint [9] 388187 0
At birth
Secondary outcome [10] 388188 0
Mode of birth (spontaneous vaginal birth, vacuum extraction, planned caesarean birth, unplanned caesarean birth), data derived from medical and maternity records (birth register book).
Timepoint [10] 388188 0
At birth
Secondary outcome [11] 388189 0
Maternal death, data derived from medical and maternity records (birth register book).
Timepoint [11] 388189 0
At birth
Secondary outcome [12] 388190 0
Apgar score (<7/10; 7/10 and above) data derived from medical and maternity records (birth register book).
Timepoint [12] 388190 0
At birth
Secondary outcome [13] 388191 0
Birth weight (<1000 g; 1000-1499 g; 1500-2499 g; >2500g) data derived from medical and maternity records (birth register book).
Timepoint [13] 388191 0
At birth
Secondary outcome [14] 388192 0
Initiation of breastfeeding (early initiation [within the first one hour of birth]; late initiation [after the first one hour of birth]), data derived from medical and maternity records (birth register book).
Timepoint [14] 388192 0
At birth
Secondary outcome [15] 388193 0
Initiation of skin-to-skin contact (early initiation of skin-to-skin contact [within the first 5 minutes of birth]; late initiation of skin-to-skin contact [after 5 minutes of birth]), data derived from medical and maternity records (birth register book).
Timepoint [15] 388193 0
At birth
Secondary outcome [16] 388194 0
Duration of skin-to-skin contact (uninterrupted skin-to-skin contact [>1 hour after birth]; interrupted skin-to-skin contact [<1 hour after birth]), data derived from medical and maternity records (birth register book).
Timepoint [16] 388194 0
At birth
Secondary outcome [17] 388195 0
Admission to a neonatal nursery ward, data derived from medical and maternity records (nursery admission register book).
Timepoint [17] 388195 0
At one week after birth and at discharge from the neonatal nursery ward
Secondary outcome [18] 388196 0
Fetal death/still birth (yes; no), data derived from medical and maternity records (birth register book).
Timepoint [18] 388196 0
At birth
Secondary outcome [19] 388197 0
Early neonatal death (within the first 7 days of life), data derived from medical and maternity records (birth register book; nursery discharge book).
Timepoint [19] 388197 0
At birth up to 7 days after birth

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed. The randomisation schedule will be stored in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a computer generated random schedule and stratified by age (<20, 20 to 30, >31 years) and parity (<P0, P1-3, >P4).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In order to detect a statistically significant difference at a 5% significance level, a sample size of 1206 women (603 per group) will have more than 90% power to detect a relative risk of preterm birth lower than 0.62 and a risk difference of at least seven percentage points for intervention group compared to comparison group. The sample size has been adjusted for 10% loss to follow up. The power calculation was based on a normal approximation with continuity correction and a prevalence of preterm birth of 19.3% for the comparison group, as reported in a prospective population-based study conducted in Malawi by Antony et al. (2020). A 43% risk reduction (Odds Ratio equal to 0.57) observed in a study by (Kildea et al., 2019) was used in calculating the sample size.

Descriptive statistics: frequencies, means, medians, standard deviations and proportions
Inferential statistics: Logistic regression; Ordinal regression; Chi-square test for categorical outcome variables; Two-sample independent t-test (for normally distributed data) or Mann-Whitney U test (for not normally distributed data); Relative risk (RR) and risk difference with 95% confidence intervals and a significance level of 5% (alpha); Multivariate analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/04/2021
Actual
1/06/2021
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
1206
Accrual to date
1131
Final
Recruitment outside Australia
Country [1] 23074 0
Malawi
State/province [1] 23074 0
Mchinji District

Funding & Sponsors
Funding source category [1] 306981 0
University
Name [1] 306981 0
Australian Government Research Training Program
Country [1] 306981 0
Australia
Funding source category [2] 307054 0
Hospital
Name [2] 307054 0
Mchinji District Hospital
Country [2] 307054 0
Malawi
Funding source category [3] 307055 0
University
Name [3] 307055 0
Kamuzu College of Nursing
Country [3] 307055 0
Malawi
Primary sponsor type
Individual
Name
Barbara Debra Zileni
Address
School of Nursing, Midwifery and Paramedicine
Curtin University
Kent St, Bentley
Western Australia 6102
Country
Australia
Secondary sponsor category [1] 307619 0
Individual
Name [1] 307619 0
Lesley Kuliukas
Address [1] 307619 0
School of Nursing, Midwifery and Paramedicine
Curtin University
Kent St, Bentley
Western Australia 6102
Country [1] 307619 0
Australia
Secondary sponsor category [2] 307620 0
Individual
Name [2] 307620 0
Yvonne Hauck
Address [2] 307620 0
School of Nursing, Midwifery and Paramedicine
Curtin University
Kent St, Bentley
Western Australia 6102
Country [2] 307620 0
Australia
Secondary sponsor category [3] 307621 0
Individual
Name [3] 307621 0
Gavin Pereira
Address [3] 307621 0
School of Public Health
Curtin University
Kent St, Bentley
Western Australia 6102
Country [3] 307621 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307113 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 307113 0
Ethics committee country [1] 307113 0
Australia
Date submitted for ethics approval [1] 307113 0
14/10/2020
Approval date [1] 307113 0
14/12/2020
Ethics approval number [1] 307113 0
HRE2020-0752
Ethics committee name [2] 307179 0
Malawi College of Medicine Research Ethics Committee
Ethics committee address [2] 307179 0
Ethics committee country [2] 307179 0
Malawi
Date submitted for ethics approval [2] 307179 0
04/01/2021
Approval date [2] 307179 0
17/03/2021
Ethics approval number [2] 307179 0
P.01/21/3243

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106078 0
Dr Lesley Kuliukas
Address 106078 0
School of Nursing, Midwifery and Paramedicine
Curtin University
Kent St, Bentley
Western Australia 6102
Country 106078 0
Australia
Phone 106078 0
+61 8 9266 2088
Fax 106078 0
Email 106078 0
[email protected]
Contact person for public queries
Name 106079 0
Lesley Kuliukas
Address 106079 0
School of Nursing, Midwifery and Paramedicine
Curtin University
Kent St, Bentley
Western Australia 6102
Country 106079 0
Australia
Phone 106079 0
+61 8 9266 2088
Fax 106079 0
Email 106079 0
[email protected]
Contact person for scientific queries
Name 106080 0
Lesley Kuliukas
Address 106080 0
School of Nursing, Midwifery and Paramedicine
Curtin University
Kent St, Bentley
Western Australia 6102
Country 106080 0
Australia
Phone 106080 0
+61 8 9266 2088
Fax 106080 0
Email 106080 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published study results only.
When will data be available (start and end dates)?
Immediately after publication, no end date determined.
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by the Principal Investigator and contact person.

Principal Investigator: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.