NCT05157828

Brief Summary

This is a cross-sectional, prospective study of iron deficiency anaemia among pregnant patients presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, over a one-week period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

4 days

First QC Date

November 29, 2021

Last Update Submit

May 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of anaemia among all women presenting for antenatal care at a secondary level institution in the Western Cape, Mowbray Maternity Hospital, during a one-week period.

    Proportion

    One week

Interventions

No intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include all consenting patients presenting to the Antenatal Clinic at Mowbray Maternity Hospital, for antenatal care, during the one-week period of recruitment.

You may qualify if:

  • All women presenting to the antenatal care services at Mowbray Maternity Hospital over the period of study recruitment.
  • ≥ 18 years of age.
  • Screen as anaemic (World Health Organisation \<11g/dl) on bedside finger-prick haemoglobin.
  • Who consent to participate.

You may not qualify if:

  • Patients who refuse to participate, and those under the age of 18 years will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mowbray maternity hospital

Cape Town, Western Cape, 7700, South Africa

Location

Study Officials

  • Christella Alphonsus, MBChB

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 15, 2021

Study Start

January 31, 2022

Primary Completion

February 4, 2022

Study Completion

February 4, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Data will be shared by PI

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Not limoited
Access Criteria
Contact PI

Locations