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The enhanced antenatal care bundle to improve maternal and newborn outcomes in Malawi: a parallel, cluster-randomized trial

The enhanced antenatal care bundle to improve maternal and newborn outcomes in pregnant women attending maternity health services in Malawi: a multi-country, parallel cluster-randomised trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16218936
Enrollment
3200
Registered
2025-03-13
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Delivery of antenatal care services Pregnancy and Childbirth

Interventions

The study will implement a package designed to improve the quality and content of antenatal care delivered in resource-limited settings and compare this with the standard antenatal care offered to pre

Sponsors

University of Liverpool
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Clusters: Primary Health Centre facilities offering maternity care will be included as a cluster following the completion of a successful feasibility report with the minimum prerequisites of: 1. A minimum of 700 ANC initial visits to a maximum of 2000 per year 2. Providers of basic emergency obstetric care 3. Public primary facility 4. Completed the site readiness assessment process Participants: clients (in process evaluation interviews and survey): 1. = 20 weeks of gestation at the initial visit to ANC 2. Able to provide informed consent 3. Willing to participate in the study 4. Aged 18 years and above Participants: HCWs (in process evaluation interviews and survey): 1. Healthcare workers responsible for the care of women during pregnancy 2. Willing to participate in the study 3. Able to provide informed consent

Exclusion criteria

Exclusion criteria: Clusters: 1. PHC with less than 700 initial ANC visits per year 2. PHCs with more than 2000 initial ANC visits per year-outliers to other facilities 3. PHCs not willing to participate in the study 4. High risk of contamination (geographically close to another participating centre or site where similar interventions are already taking place) Participants: clients (in process evaluation - interviews and survey): 1. >20 weeks of gestation at the initial visit to ANC 2. Unable to provide informed consent 3. Medical and obstetric complications on the initial visit 4. Aged less than 18 years Participants: HCWs (in process evaluation - interviews and survey): 1. Not willing to participate in process evaluation 2. Unable to provide informed consent

Design outcomes

Primary

MeasureTime frame
1. Maternal mortality: 1.1. Maternal deaths 2. Newborn mortality: 2.1. Stillbirths 2.2. Neonatal deaths 3. Maternal morbidity: 3.1. (Pre)-eclampsia 3.2. Uterine rupture 3.3. Antepartum haemorrhage 3.4. Postpartum haemorrhage 3.5. Maternal sepsis 4. Newborn morbidity: 4.1. Birth asphyxia 4.2. Prematurity (born before 37 weeks gestation) 4.3. Low birthweight (weight less than 2500 g) 5. Emergency obstetric referrals 6. Appropriate emergency referrals Measured by monthly collection of routine health facility records for maternity ward records from the baseline phase to the end of cluster participation. In addition to the primary and secondary outcomes listed here, the researchers may evaluate general process outcomes as described in the protocol attached.

Secondary

MeasureTime frame
1. Proportion of women with the following obstetric complications: 1.1. (Pre)-eclampsia 1.2. Anaemia (Hb less than 7g/dl) 1.3. Syphilis 2. Proportion of women referred out for any cause, or due to pre/eclampsia, anaemia and risk for obstruction of labour 3. Proportion of newborns with the following complications: neonatal sepsis 4. Proportion of neonatal unit (NNU) admission for any cause 5. Proportion of newborn breastfeeding initiated within 60 minutes of birth 6. Proportion Kangaroo Mother Care (KMC) admissions 7. Proportion of newborns resuscitated 8. Proportion of newborns received antibiotics 9. Proportion of women starting antenatal care (ANC) visit in the first trimester (<12 weeks) 10. Average total ANC visits per woman 11. Proportion of women who received required doses of the following (data from registers): 11.1. Tetanus toxoid vaccination (TTV) (=2 doses) 11.2. Sulphadoxine-pyrimethamine (SP) (=3 doses) Measured by monthly collection of routine health facility maternity and neonatal records and cohort records (6 months prior to reporting month) for ANC data records, from the baseline to the end of cluster participation. In addition to the primary and secondary outcomes listed here, the researchers may evaluate general process outcomes as described in the protocol attached.

Countries

Malawi

Contacts

Public ContactNancy Medley
nmedley2@liverpool.ac.uk+44 (0)1517942064

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026