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Birth canal dilator study

Perineal dilator for delivery: a randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201801002864315
Enrollment
Unknown
Registered
2017-12-12
Start date
2017-07-03
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

Pregnancy and Childbirth labour, delivery

Interventions

Use of perineal dilator
Routine care

Sponsors

Effective Care Research Unit, University of Witwatersrand and Fort Hare
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Nulliparous women Aged 18 years or above No major complications of pregnancy In active labour Vaginal birth anticipated Consent given

Exclusion criteria

Exclusion criteria: Any contra-indication to use of dilator

Design outcomes

Primary

MeasureTime frame
Spontaneous delivery within 15 minutes of bearing down—

Secondary

MeasureTime frame
Assisted delivery;Caesarean section;Episiotomy;Perineal tears;Number of perineal sutures;Apgar score;Arterial cord blood pH or lactate;Maternal satisfaction;Urinary incontinence;Flatus incontinence;Faeces incontinence;Perineal pain;Dyspareunia—

Countries

South Africa

Contacts

Public ContactG Justus Hofmeyr

Director

justhof@gmail.com0832809402

Outcome results

None listed

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