Plain English Summary
Background and study aims
Perineal injury is very common at a first delivery. Perineal massage or warm compress may reduce very severe perineal injury but studies have shown less clear cut benefit where less severe injury is concerned. There is no reported study where massage and warm compress to the perineum are combined as a single intervention. Combined perineal massage and warm compress during active second stage of labour may protect the perineum compared to the standard care of no intervention to the perineum. The aim of this study is to assess the impact of combined perineal massage and warm compress on sutured perineal injury (including episiotomy and spontaneous tear).
Who can participate?
Women aged over 18 who are giving birth for the first time
What does the study involve?
Participants are randomly allocated to be treated with combined perineal massage and warm compress or usual care (control group). Perineal massage is performed during contractions to minimize contractions. A generous quantity of KY jelly is poured onto the fingers and using a gentle, slow massage with two 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 is maintained at an intensity at which the woman does not feel any pain. Warm compress is applied between contractions. A sterile towel is soaked in a 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 is re-soaked in the water to maintain warmth then applied again. Sutured perineal injuries (including episiotomy or spontaneous perineal tear) are recorded when the baby is delivered.
What are the possible benefits and risks of participating?
Perineal injury might be decreased if these techniques are effective. However, it is also possible that massage and warm compress to the perineum may increase injury. Perineal massage may cause minor abrasion and pain and warm compress may cause discomfort.
Where is the study run from?
University of Malaya Medical Centre (Malaysia)
When is the study starting and how long is it expected to run for?
January 2018 to May 2018
Who is funding the study?
University of Malaya Medical Centre (Malaysia)
Who is the main contact?
Dr Goh Yi Pei
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
2017105-5637
Study information
Scientific title
Combined massage and warm compress to the perineum during active second stage of labour In nulliparas: a randomised trial
Acronym
MASSCOMP
Study hypothesis
Combined perineal massage and warm compress during active second stage of labour will decrease the rate of perineal injuries that require suturing.
Ethics approval(s)
Medical Ethics Board of University of Malaya Medical Centre, 15/12/2017, ref: 2017105-5637
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Prevention
Patient information sheet
See additional files
Condition
Perineal injury, including episiotomy, or spontaneous perineal tears that require suturing
Intervention
Randomisation was done via random.org with both blocks of 4 and blocks of 8 methods. Participants are randomised to be treated with combined perineal massage and warm compress or usual care (control group).
Perineal massage will be performed during contractions to minimize contractions. A generous quantity of KY jelly will be poured onto the 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.
Warm compress will be applied between contractions. A sterile towel will be soaked in a metal container filled with warm water (~50◦C) and squeezed before being placed gently on the perineum during each uterine contraction. The temperature should ranged 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. 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.
Control management is without application of combined massage and warm compress to the perineum.
Follow-up is within a day postpartum (the patients will not have a time-framed follow-up).
Intervention type
Procedure/Surgery
Primary outcome measure
Sutured perineal injury (including episiotomy or spontaneous perineal tear), measured instantly after baby is out
Secondary outcome measures
1. Maternal outcomes, measured instantly after baby is out:
1.1. Interval from intervention to delivery
1.2. Mode of delivery
1.3. Third- and fourth-degree perineal tears
1.4. Maternal satisfaction with intervention, measured using VAS
1.5. Estimated blood loss at delivery
2. Fetal outcomes, measured instantly after baby is out:
2.1. Apgar score at 1 min and 5 min
2.2. Birth weight
2.3. Arterial cord pH
2.4. Neonatal admission and indication
Overall study start date
01/01/2018
Overall study end date
31/05/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current participant inclusion criteria as of 28/08/2018:
1. Presumed labour (including ruptured membrane)
2. Nulliparous
3. Age > 18
4. Gestational age of > 37 weeks at enrolment
5. Singleton pregnancy
6. Planned vaginal birth
7. Cephalic presentation
8. Reassuring fetal status
9. Not distressed by pain that may impact decision making
10. In active second stage pushing
Previous participant inclusion criteria:
1. Presumed labour (including ruptured membrane)
2. Nulliparous
3. Age > 18
4. Gestational age of > 37 weeks at enrolment
5. Singleton pregnancy
6. Planned vaginal birth
7. Cephalic presentation
8. Reassuring fetal status
9. Not distressed by pain that may impact decision making
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
156
Total final enrolment
156
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
15/01/2018
Recruitment end date
31/03/2018
Locations
Countries of recruitment
Malaysia
Study participating centre
University of Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
Sponsor information
Organisation
University of Malaya Medical Centre
Sponsor details
Department of Obstetrics & Gynaecology
Lembah Pantai
Federal Territory of Kuala Lumpur
59100
Malaysia
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Department of Obstetrics & Gynaecology, University of Malaya Medical Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in high-impact peer reviewed journal such as "The Obstetrics & Gynaecology", "BJOG : An International Journal O&G", and "The Urogynaecology Journal", tentatively next year in 2019 if possible.
Intention to publish date
31/05/2019
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Goh Yi Pei. The data is hardcopy type, will become available once the study is done, and will be anonymised.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/04/2019 | No | Yes | ||
| Protocol file | 01/04/2019 | No | No | ||
| Results article | 23/01/2021 | 09/09/2021 | Yes | No |
Additional files
- ISRCTN42773879_PIS.docx Uploaded 01/04/2019
- ISRCTN42773879_PROTOCOL.docx Uploaded 01/04/2019