NCT02587091

Brief Summary

A cluster randomized trial was conducted across eight rural sub-counties in southwestern Uganda. This study was conducted to determine the impact of advertising free obstetric ultrasound on the attendance to antenatal care clinics.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

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

Study Start

First participant enrolled

February 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

Same day

First QC Date

October 23, 2015

Last Update Submit

October 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total attendance to antenatal care clinic

    The primary outcome in this study was attendance to antenatal care clinic in each sub-county

    9 days

Secondary Outcomes (3)

  • Attendance to antenatal care clinic by women who had previously seen a traditional healer/birth attendant

    9 days

  • Attendance to antenatal care clinic by women who had not previously received antenatal care services in their current pregnancy

    9 days

  • Attendance to antenatal care clinic specifically because of portable obstetric ultrasound

    9 days

Study Arms (2)

Control Arm

NO INTERVENTION

In this arm communities were told by word of mouth advertisement that a comprehensive antenatal care clinic would be held. There was no advertisement of portable ultrasound.

Intervention Arm

EXPERIMENTAL

In this arm communities were told by word of mouth advertisement that a comprehensive antenatal care clinic would be held. In addition, it was advertised that portable ultrasound would be provided free of charge in addition to standard comprehensive antenatal care.

Behavioral: Portable obstetric ultrasound

Interventions

This intervention was advertised at the cluster level

Intervention Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be residents of the Kabale Region
  • All pregnant women aged 18 and above who present to one of the antenatal care clinics

You may not qualify if:

  • Pregnant women under the age of consent (under 18 years); and any males or non-pregnant females who attend the health camps will be excluded from the study.\*
  • All participants excluded from the study will still be offered free medical and dental care as part of a mobile free medical/dental clinic that will be offered in the same community at the same time but in a neighbouring location. For pregnant women under the age of 18, free obstetric ultrasound will also be offered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 27, 2015

Study Start

February 1, 2014

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

October 27, 2015

Record last verified: 2015-10