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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

PACTR

Registry ID

PACTR201907835500506

Enrollment

Registered

2019-07-01

Start date

2019-07-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Examination of lower genital tract

Interventions

SOFT speculum

Current standard practice

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria: Not fulfilling inclusion criteria

Design outcomes

Primary

Measure	Time frame
Quality of visualization as assessed by the clinician	—

Secondary

Measure	Time frame
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	—

Countries

South Africa

Contacts

Public ContactGeorge Justus Hofmeyr

Director ECRU

justhof@gmail.com+27832809402

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026