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Randomized evaluation of a new design obstetric birth canal speculum (the ‘SOFT’ speculum)

Phase 1
Conditions
Examination of lower genital tract
Registration Number
PACTR201907835500506
Lead Sponsor
niversity of the Witwatersrand
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Female
Target Recruitment
80
Inclusion Criteria

Pregnant or delivered women,
18 years or older,
with no serious complications
requiring visualization of the lower genital tract as a non-urgent procedure
for whom the attending clinician considers that the SOFT speculum is a suitable choice,
and who give informed consent.

Exclusion Criteria

Not fulfilling inclusion criteria

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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