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DIPLOMATIC

Evaluating the implementation of routine antenatal US for estimating date of delivery in Malawi and Zambia; an interrupted time series trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202010788566263
Enrollment
12000
Registered
2020-10-19
Start date
2020-10-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pregnancy and Childbirth

Interventions

Ultrasound and Estimated Gestational Age Training
Pre Implementation

Sponsors

University of Edinburgh ACCORD office
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Service providers (including obstetricians, clinicians, midwives and maternity based support staff) in a participating facility. All women attending for antenatal care at any of the participating sites will automatically be enrolled into the study and excluded only if they do not wish to participate.

Exclusion criteria

Exclusion criteria: Women who do not wish to participate. In this situation they would proceed with routine antenatal care without having an ultrasound scan. They may however, still be unavoidably exposed to educational materials. Their pregnancy data would not be collected. Service providers who do not wish to participate. In this situation we would encourage them to engage for a short interview to explain the reasons for their reluctance, allowing us to better understand and address barriers to implementation.

Design outcomes

Primary

MeasureTime frame
To provide an accurate EDD for each pregnant woman, which is used to assign gestational age consistently throughout pregnancy and at delivery and to evaluate stakeholders’ perceptions of the interventions and their implementation and to review overall client satisfaction. Primary process outcome measures EDD assigned by USS prior to 24+6 Gestational age assessment made on criteria other than EDD established by USS prior to 24+6 weeks at any time during pregnancy

Secondary

MeasureTime frame
Secondary process outcome measures • EDD assigned by USS is used to document gestational age at delivery • Multiple pregnancy diagnosed for the first time at delivery • Mean gestational age at first presentation to antenatal services • Rates of referral for suspected preterm delivery • Rates of referral for management of post-dates Safety outcomes • Stillbirth rates • Rates of pre-term delivery • Rates of LBW delivery • Rates of referral for obstetric emergency • Maternal mortality rates • Perinatal mortality rates • Coverage of routine ANC care delivery at ANC1 • Coverage of routine ANC care delivery by time of delivery Features and frequency of USS referred by midwives • Nature of queries • Frequency of queries over time • Outcome of expert assessment Baseline data will be collected on: • Patient characteristics • Facility characteristics Quality and validity of USS assessments • Correlation of subset of quality metrics related to US delivery

Countries

Malawi, Zambia

Contacts

Public ContactPatricia Munthali

Project Coordinator Malawi

pmunthalikhomani@mlw.mw26501812423

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026