Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201907835500506 Date of Approval: 01/07/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomized evaluation of a new design obstetric birth canal speculum (the ‘SOFT’ speculum)
Official scientific title Randomized evaluation of a new design obstetric birth canal speculum (the ‘SOFT’ speculum)
Brief summary describing the background and objectives of the trial Background Several clinical procedures require clear visualisation of the vagina and cervix in pregnant women. These include inspection for the source of antepartum vaginal bleeding; confirmation of suspected rupture of membranes; assessment of the cervix; insertion of extra-amniotic Foley catheter for labour induction; examination and suturing of postpartum cervical and vaginal tears; postpartum insertion of the intrauterine device; and examination for source of postpartum bleeding. Available vaginal speculums such as the Cusco speculum are often used, but give poor visualisation as they are designed for non-obstetric use. The laxity of vaginal tissues during pregnancy and particularly postpartum results in loose tissues obstructing visualisation. The anterior and posterior orientation of the speculum blades may cause discomfort due to pressure on the clitoral region and the perineum, and in the case of postpartum inspection, obscuring the posterior vaginal wall, the most common site of tears. Obstetricians frequently resort to improvisation with other instruments such as the obstetric forceps with blades curved outwards to improve visualisation, particularly for postpartum inspection. This often requires an assistant. The PI has designed a simple plastic self-retaining retractor with blades similar in profile to the standard Cusco speculum, but instead of two anterior and posterior blades, four blades orientated diagonally to avoid pressure on and provide a view of anterior and posterior structures. The simple sliding ratchet mechanism is expected to be easier to use and release than the screw mechanism of the Cusco speculum. The instrument is called the Self-retaining Obstetric Flexible Traction speculum (‘SOFT’ speculum) Current Study Objectives To conduct a limited size, randomized pilot study of the SOFT speculum for visualization of the lower genital tract of Obstetric participants
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SOFT speculum
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Examination of lower genital tract
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/07/2019
Actual trial start date
Anticipated date of last follow up 31/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SOFT speculum N/A Duration of lower genital tract examination (typically < 2 minutes) New design of Self-retaining Obstetric Flexible Traction (SOFT) speculum will be inserted vaginally with chlorhexidine lubricant to visualize the lower genital tract 40
Control Group Current standard practice N/A For duration of examination (typically <2 minutes) Currently available speculum according to preference of clinician, eg Sim's, Cusco, obstetric forceps 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. Not fulfilling inclusion criteria Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/06/2019 University of the Witwatersrand Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
York Rd, Parktown, JHB, SA JHB 2000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quality of visualization as assessed by the clinician After procedure
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. After procedure
Secondary Outcome Complications After procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Frere Maternity Hospital Amalinda Drive East London 5201 South Africa
Cecilia Makiwane Hospital Billie Rd Mdantsane 5201 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
GJ Hofmeyr Frere Hospital, Amalinda Drive East London 5201 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand York Rd, Parktown JHB 2000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Mandisa Singata Madliki Amalinda Drive East London 5201 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator George Justus Hofmeyr justhof@gmail.com +27832809402 Frere Hospital Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director Effective Care Research Unit
Role Name Email Phone Street address
Public Enquiries George Justus Hofmeyr justhof@gmail.com +27832809402 Frere Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director ECRU
Role Name Email Phone Street address
Scientific Enquiries George Justus Hofmeyr justhof@gmail.com 27832809402 Frere Hospital, Amalinda Drive
City Postal code Country Position/Affiliation
East London 5201 South Africa Director ECRU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Baseline characteristics, group allocation and outcomes of trial participants Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months Controlled access for scientific purposes as approved by trial steering committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information