Is the length of the perineal body associated with the extent of perineal injury among women undergoing vaginal delivery

ISRCTN ISRCTN54617454
DOI https://doi.org/10.1186/ISRCTN54617454
Sponsor Hospital Tuanku Ja’afar
Funder Investigator initiated and funded
Submission date
22/09/2026
Registration date
23/09/2026
Last edited
30/10/2026
Recruitment status
Not yet recruiting
Overall study status
Ongoing
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
During vaginal childbirth, the perineum (the area of tissue between the vaginal opening and the anus) stretches to allow the baby to be delivered. This can sometimes result in perineal injury, including tears of varying degrees.
This study aims to determine whether the length of the perineal body is associated with the extent of perineal injury among women undergoing vaginal delivery. The study will also examine the occurrence of obstetric anal sphincter injury (OASI), which involves third- and fourth-degree perineal tears affecting the anal sphincter.

Who can participate?
Adult women who are admitted to the labour room and meet the study eligibility criteria may participate.

What does the study involve?
Participants who consent to the study will undergo measurement of their perineal body length during their first vaginal examination in the labour room, before full cervical dilatation and active pushing.
The measurement will be taken in centimetres, from the posterior fourchette (the back edge of the vaginal opening) to the anterior margin of the anus, using a clean, single-use wooden measuring tool.
The study team will record relevant labour and delivery information, including the extent of perineal injury following vaginal delivery.
No medication, procedure or intervention will be administered to alter the participant's labour or delivery as part of this study.
The expected number of participants is 1,600 women. (1600 women will be screened).

What are the possible benefits and risks of participating?
Possible benefits:
Participants may not receive any direct personal benefit from taking part. However, the information collected may improve understanding of the relationship between perineal body length and perineal injury during vaginal delivery, potentially contributing to future research and improvements in obstetric care.

Possible risks:
The study involves minimal additional risk. Perineal body measurement is non-invasive and performed as part of the vaginal examination process. Participants may experience temporary discomfort or embarrassment during the examination and may request that the measurement be stopped at any time.

Where is the study run from?
Hospital Tuanku Ja’afar, Seremban, Malaysia, under the Department of Obstetrics & Gynaecology.

When is the study starting and how long is it expected to run for?
November 2026 to October 2027.

Who is funding the study?
Investigator initiated and funded.

Who is the main contact?
Dr Sabeetha Segaran, Department of Obstetrics & Gynaecology, Hospital Tuanku Ja’afar, sabeethasegaran@moh.gov.my, sabeetha23@gmail.com

Contact information

Dr Sabeetha Segaran
Principal investigator, Scientific, Public

No 25, Jalan 20/8, Paramount Gardens
Petaling Jaya
46300
Malaysia

+60163225967
sabeethasegaran@moh.gov.my
Dr Joanne Lim Xu Mei
Public, Scientific

Hospital Tuanku Ja'afar, Jalan Rasah, Bukit Rasah, Seremban, Negeri Sembilan
Seremban
70300
Malaysia

+60126369829
joannelim.xm@gmail.com
Dr Gurunethra Ledchumanan
Public

Hospital Tuanku Ja'afar, Jalan Rasah, Bukit Rasah, Seremban, Negeri Sembilan
Seremban
70300
Malaysia

+60139323128
netz1musique@gmail.com
Dr Ilamathi Ramamoorthy
Public

Hospital Tuanku Ja'afar, Jalan Rasah, Bukit Rasah, Seremban, Negeri Sembilan
Seremban
70300
Malaysia

+6012794 4194
ilamathi83@gmail.com
Dr Ganesinee Subramaniam
Public

Hospital Tuanku Ja'afar, Jalan Rasah, Bukit Rasah, Seremban, Negeri Sembilan
Seremban
70300
Malaysia

+60 126796050
ganesinee88@gmail.com
Dr Sutheskumar Letchumanan
Public

Hospital Tuanku Ja'afar, Jalan Rasah, Bukit Rasah, Seremban, Negeri Sembilan
Seremban
70300
Malaysia

+60 142649285
sutheskumar26@gmail.com

Study information

Primary study designObservational
Observational study designCohort study
Participant information sheet 50327_PIS_English.pdf
Scientific titleImpact of perineal body length on the extent of perineal injury during labour
Study objectives Primary Objective
To determine the association between perineal body length and the extent of perineal injury among women undergoing vaginal delivery at Hospital Tuanku Ja’afar, Seremban

Secondary Objective
1. To determine the association between perineal body length and the occurrence of obstetric anal sphincter injury (OASI)
2. To determine the association between perineal body length and the degree of perineal tear
3. To determine the association between perineal body length and the occurrence of episiotomy
4. To determine the association between maternal, obstetric and neonatal factors and the extent of perineal injury
5. To determine the association between maternal, obstetric and neonatal factors and OASI
6. To explore whether a clinically relevant perineal body length threshold can be identified for predicting extensive perineal injury and/or OASI
Ethics approval(s)

Submitted 06/09/2026, Medical Research and Ethics Committee (MREC) of the Ministry of Health Malaysia (Level 2, Blok A1, National Institutes of Health (NIH) No 1 Jalan Setia Murni U13/52, Seksyen U13 Bandar Setia Alam, Shah Alam, 40170, Malaysia; +603-3362 8398/8399/8404/8408; mrecsec@moh.gov.my), ref: RSCH ID-26-06205-PP5

Health condition(s) or problem(s) studiedEligible women in first stage of labour who are admitted to the labour room in Hospital Tuanku Ja'afar, Seremban
MethodologyMeasurement Protocol of Perineal Body Length
Perineal body length is defined as the midline distance, measured in centimeters, between the posterior fourchette and the anterior margin of the anus.
Timing: Done during First stage of labour – before the very first vaginal examination in labour room prior to full cervical dilatation and active pushing.
Position: Participants will be placed in dorsal lithotomy position for the measurement
Anatomical Landmarks: midline distance, measured in centimeters, between the posterior fourchette and the anterior margin of the anus
Instruments: A single-use wooden tongue depressor, pre-marked with measurements from 0 to 6 cm at 0.1-cm intervals. The measurement will be recorded to the nearest 0.1 cm. A new tongue depressor will be used for each participant.
Units: Centimetres
Observer: The measurement will be performed by the medical doctor conducting the first vaginal examination upon the participant's admission to the labour room. All clinicians involved in data collection will undergo standardized training using the same anatomical landmarks and measurement technique before commencement of the study.
Intervention typeOther
Primary outcome measure(s)
  1. Extent of perineal injury, defined as the highest degree of perineal tissue disruption sustained during vaginal delivery and classified as intact perineum, first-degree, second-degree/episiotomy or obstetric anal sphincter injury (3A, 3B, 3C or fourth-degree tear), measured using an assessment and diagnosis by the certified midwives, nurses or medical doctor who conducts the women's delivery, at the time of delivery of the baby and placenta and before the commencement of perineal injury repair
Key secondary outcome measure(s)
  1. Obstetric Anal Sphincter Injury (OASI) measured using an assessment by the medical doctor in-charge of post delivery and the findings will be confirmed by the consultant/ specialist obstetrics and gynaecology, at the operative theater by the consultant/ specialist obstetric gynaecology
Completion date31/10/2027

Eligibility

Participant type(s)
Age groupAdult
Lower age limit18 Years
Upper age limit50 Years
SexFemale
Target sample size at registration815
Key inclusion criteria1. Maternal age ≥18 years
2. Gestational age ≥37+0 weeks
3. Singleton pregnancy
4. Cephalic presentation
5. Admitted in labour and subsequently undergoing vaginal delivery
Key exclusion criteria1. Caesarean section
2. Non-cephalic presentation
3. Preterm delivery <37+0 weeks
4. Multifetal pregnancy
Date of first enrolment16/11/2026
Date of final enrolment30/04/2027

Locations

Countries of recruitment

  • Malaysia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications 22/09/2026 Yes No
Participant information sheet version 1.0 14/09/2026 22/09/2026 No Yes
Participant information sheet 22/09/2026 No Yes
Protocol file 22/09/2026 No No

Additional files

50327_PIS_v1.0_14Sept2026_Registration in Malaysia's National Medical Research Register (NMRR).pdf
Participant information sheet
50327_Protocol.pdf
Protocol file
50327_PIS_English.pdf
Participant information sheet
50327_Gantt_Chart_Provisional 12-month schedule.pdf
Other publications

Editorial Notes

30/10/2026: Date of first enrolment was updated from 02/11/2026 to 16/11/2026.
21/10/2026: Date of first enrolment was updated from 19/10/2026 to 02/11/2026.
22/09/2026: Study’s existence confirmed by the National Medical Research Register, Malaysia.

BMC - Part of Springer Nature Springer Nature