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

Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2019
INTERVENTION: Current standard practice SOFT speculum CONDITION: ; Examination of lower genital tract Examination of lower genital tract PRIMARY OUTCOME: Quality of visualization as assessed by the clinician SECONDARY OUTCOME: 2. Comfort as reported by the participant using a structured questionnaire (attached) administered blind to allocation by the Co‐PI or a GCP trained research assistant. Complications 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.
Epistemonikos ID: 07c6044173d12bf675cab3e5da0c13d3c14f0763
First added on: Aug 24, 2024