Iron Deficiency Anaemia in Pregnant Patients Presenting f... | NCT05157828

Studies
Iron Deficiency Anaemia in Pregnant Patients Presenting for Antenatal Care

NCT05157828

Sponsor

University of Cape Town

Status

Completed

Last Update Posted

May 18, 2022Actual

Enrollment

132Actual

Phase

Not provided

Conditions

Iron Deficiency Anemia of Pregnancy

Interventions

No intervention

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2022Actual

Primary Completion Date

Feb 4, 2022Actual

Completion Date

Feb 4, 2022Actual

First Submitted Date

Nov 29, 2021

First Submission Date that Met QC Criteria

Dec 14, 2021

First Posted Date

Dec 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2022

Last Update Posted Date

May 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant patients

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christella Alphonsus, MBChB	University of Cape Town	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mowbray maternity hospital		Cape Town	Western Cape	7700	South Africa

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be shared by PI

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Not limoited

Access Criteria

Contact PI

URL

Not provided