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Register:	ISRCTN
Last refreshed on:	20 September 2021
Main ID:	ISRCTN42773879
Date of registration:	27/02/2018
Prospective Registration:	No
Primary sponsor:	University of Malaya Medical Centre
Public title:	Combined massage and warm compress to the perineum during pushing in women delivering for the first time
Scientific title:	Combined massage and warm compress to the perineum during active second stage of labour In nulliparas: a randomised trial
Date of first enrolment:	15/01/2018
Target sample size:	156
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN42773879
Study type:	Interventional
Study design:	Randomised controlled trial (Prevention)
Phase:	Not Applicable

Countries of recruitment
Malaysia

Contacts

Name:	Yi Pei Goh
Address:	University of Malaya Medical Centre Department of Obstetrics & Gynaecology Lembah Pantai 59100 Federal Territory of Kuala Lumpur Malaysia
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

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)

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Perineal injury, including episiotomy, or spontaneous perineal tears that require suturing
Pregnancy and Childbirth
Perineal laceration during delivery, unspecified

Intervention(s)

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).

Primary Outcome(s)

Sutured perineal injury (including episiotomy or spontaneous perineal tear), measured instantly after baby is out

Secondary Outcome(s)

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

Secondary ID(s)

2017105-5637

Source(s) of Monetary Support

Department of Obstetrics & Gynaecology, University of Malaya Medical Centre

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Medical Ethics Board of University of Malaya Medical Centre, 15/12/2017, ref: 2017105-5637

Results

Results available:	Yes
Date Posted:
Date Completed:	31/05/2018
URL:

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