Combined massage and warm compress to the perineum during pushing in women delivering for the first time

Combined massage and warm compress to the perineum during active second stage of labour In nulliparas: a randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42773879

Enrollment

156

Registered

2018-02-27

Start date

2018-01-15

Completion date

Unknown

Last updated

2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 g

Eligibility

Sex/Gender

Female

Inclusion 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

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 16, 2026