Comparing combined perineal massage and warm compress versus perineal massage during the second stage of labour in nulliparous women
| ISRCTN | ISRCTN10088409 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10088409 |
- Submission date
- 27/05/2019
- Registration date
- 12/06/2019
- Last edited
- 11/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Universiti Malaya Medical Centre
Jalan Universiti
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Phone | +60139886381 |
|---|---|
| suriyanti@siswa.um.edu.my |
Scientific
University Malaya Medical Centre
Jalan Universiti Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Phone | +60123052970 |
|---|---|
| tanpengchiong@yahoo.com |
Study information
| Study design | Single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Combined perineal massage and warm compress versus perineal massage during second stage in nulliparous - randomized control trial |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 07/02/2019 |
| Completion date | 07/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 280 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 14/06/2019 |
| Date of final enrolment | 07/12/2019 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Sponsor information
University/education
Department of Obstetric & Gynaecology
Jalan Universiti
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Phone | 0379494422 |
|---|---|
| fomadmin@um.edu.my | |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
