Condition category
Pregnancy and Childbirth
Date applied
27/05/2019
Date assigned
12/06/2019
Last edited
11/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Vaginal birth can be associated with perineal tears and can be associated with both short and long-term morbidities eg pain, dyspareunia, bleeding and prolong recovery and nulliparous (no previous childbirth) women are at increased risk for perineal tear compared to multiparous (previously given birth) women.
Available techniques to prevent tears during the second stage of labour include perineal massage and warm compress, which have shown a reduction in perineal trauma. Thus this study was done to evaluate the effects of combined perineal massage and warm compression versus perineal massage alone during the active second stage of labour with the need for suturing of perineal trauma at vaginal birth.

Who can participate?
Nulliparous woman presenting in labour with presumed labour with age > 18 years old however the final recruitment only when patient achieve active second stage.

What does the study involve?
Participants will receive usual care during labour until the patient starts to push, then actual intervention will be started. Final eligibility for study entry of those recruited is only fulfilled when the woman in the second stage and about to commence pushing. Only at this point is a sealed envelope assigned and subsequently opened to decide the intervention to be carried out. The intervention will either be perineal massage alone or combined perineal massage with warm compression.

What are the possible benefits and risks of participating?
Both interventions are safely used during the second stage of labour

Where is the study run from?
University Malaya Medical Centre, Malaysia

When is the study starting and how long is it expected to run for?
June 2019 to December 2019

Who is funding the study?
Investigator funded

Who is the main contact?
Suriyanti Ahmad Shukri,
suriyanti@siswa.um.edu.my

Trial website

Contact information

Type

Scientific

Primary contact

Dr Suriyanti Ahmad Shukri

ORCID ID

Contact details

Universiti Malaya Medical Centre
Jalan Universiti
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+60139886381
suriyanti@siswa.um.edu.my

Type

Scientific

Additional contact

Prof Tan Peng Chiong

ORCID ID

Contact details

University Malaya Medical Centre
Jalan Universiti Lembah Pantai
Kuala Lumpur
50603
Malaysia
+60123052970
tanpengchiong@yahoo.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Combined perineal massage and warm compress versus perineal massage during second stage in nulliparous - randomized control trial

Acronym

Study hypothesis

Combine warm compress and perineal massage compared to perineal massage alone in nulliparous woman during second stage should result in less perineal suturing

Ethics approval

Approved 29/04/2019 Medical research Ethics Committee, University Malaya Medical Centre (Pusat Perkhidmatan Penyelidikan (PPP), Tingkat 2, Institut Pengurusan & Perkhidmatan Penyelidikan (IPPP), University of Malaya, 50603, Kuala Lumpur, Malaysia; 03-79677022 (ext : 2369); umrec@um.edu.my), ref: 201926-7105

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Nulliparous women in the second stage of pregnancy

Intervention

This is a randomised control trial involving nulliparous patient at term ( >_37 weeks) who are admitted to an antenatal ward or labour ward of UM Hospital. Eligible patients will be identified using eligibility form and patient information sheet will be provided for those who fulfilled initial eligible criteria. Those who agreed to participate will be asked to provide written consent and will be recruited in this study.
Participants will receive usual care during labour until the patient starts to push, then actual intervention will be started. Final eligibility for study entry of those recruited is only fulfilled when the woman in the second stage and about to commence pushing. Only at this point is sealed number of envelope assigned and subsequently opened for the intervention to be carried out. Intervention will either be perineal massage alone or combine perineal massage with warm compression.
Perineal massage will be performed during contractions. A generous quantity of the KY-jelly will be poured onto fingers and using a gentle, slow massage, with 2 fingers of the gloved hand moving from side to side just inside the patient’s vagina. Mild, downward pressure (towards the rectum) is applied with steady, lateral strokes, which last 1 second in each direction. Pressure will be maintained at an intensity at which the woman did not feel any pain.
A warm compress will be applied between contractions. A sterile towel will be soaked in metal container filled with warm water (~50◦C) and squeezed before being placed gently on the perineum during each uterine contraction. The temperature should range from 38◦C to 44◦C during its application. During contractions, the towel should be re-soaked in the water to maintain warmth then reapplied again once the contraction is over. The water in the metal container will be replaced every 15 minutes until delivery or if the temperature dropped below 45◦C. The water temperature will be checked with a thermometer placed into the container.
Total duration of treatment will be during the second stage only.
Patient will be followed up soon after delivery for the outcomes.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Requirement for suturing for perineal injury (Episiotomy / spontaneous tears) measured after delivery.

Secondary outcome measures

Maternal outcomes
1. Interval from intervention to delivery
2. Mode of delivery: Vaginal delivery / Operative vaginal delivery / caesarean delivery
3. Indication for operative vaginal delivery/caesarean section
4. Perineal status: Intact, 1st degree, 2nd degree, 3rd degree, 4th degree tear
5. Maternal satisfaction with intervention (rate 1 - 10)
6. Estimated blood loss at delivery

Fetal outcomes
1. Apgar score at 1 min and 5 min
2. Birth weight
3. Arterial cord pH
4. Reason and location of neonatal admission and indication

Overall trial start date

07/02/2019

Overall trial end date

07/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1 Initial recruitment: Presumed labour / Final recruitment: During active second stage
2 Nulliparous and no previous pregnancy beyond 20 week
3. Age of > 18
4. Gestational age of > 37 weeks at enrolment confirmed by ultrasound greater or less than 20 week
5. Singleton pregnancy
6. Planned vaginal birth
7. Cephalic presentation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

280

Participant exclusion criteria

1. Has performed antenatal perineal massage
2. Gross fetal anomaly
3. Gross perineal scarring (e.g. female genital mutilation)
4. Caesarean section (post-randomisation exclusion)

Recruitment start date

14/06/2019

Recruitment end date

07/12/2019

Locations

Countries of recruitment

Malaysia

Trial participating centre

University Malaya Medical Centre
Jalan Universiti Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University Malaya Medical Centre

Sponsor details

Department of Obstetric & Gynaecology
Jalan Universiti
Lembah Pantai
Kuala Lumpur
50603
Malaysia
0379494422
fomadmin@um.edu.my

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

01/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes