Cold compared with room temperature compress on the perineal repair site following normal vaginal delivery in women who have delivered their first child

Cold compared with room temperature compress on the perineal repair site following normal vaginal delivery in primiparous women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13570188

Enrollment

222

Registered

2022-04-05

Start date

2022-05-09

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

Supportive care for perineal wound sustained in primiparous women during normal vaginal delivery. Pregnancy and Childbirth

Interventions

Patient who are agreed to participate in this study, will be randomised to: 1. Cold compress (frozen gel pack) - experimental group, or 2. Room temperature compress (using identical gel pack, soft at

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Nulliparous 2. Planning to have a normal birth 3. =18 years old 4. =37 weeks gestation 5. Singleton birth 6. Spontaneous vaginal delivery (SVD) 7. Sutured second degree perineal injury: spontaneous or episiotomy 8. Apgar score at 5 minutes =9

Exclusion criteria

Exclusion criteria: 1. Post-partum haemorrhage (=1000 ml) 2. Indwelling bladder catheter 3. Admission to high dependency or intensive care 4. Extended or multiple vaginal tears 5. Vulva-vaginal haematoma 6. Cold allergy

Design outcomes

Primary

Measure	Time frame
Perineal pain score measured using a 0-10 numerical rating scale (NRS) at mobilisation, at 12 h after delivery, and 24 h after delivery	—

Secondary

Measure	Time frame
Measured at pre-discharge using patient records: 1. Time to first flatus 2. Time to first satisfactory breastfeeding experience 3. Time to first urination 4. Time to ambulation 5. VNRS: Satisfaction with allocated compress to your perineal repair site (@24 H) 6. Analgesia used Measured at 14 days after delivery (by telephone): 7. Oral analgesia use for perineal pain 8. VNRS pain score during mobilisation Measured at 6 weeks after delivery (by telephone): 9. Oral analgesia use for perineal pain 10. VNRS pain score during mobilisation 11. Resumption of vagina intercourse 12. Exclusive breastfeeding 13. Perineal healing (Likert scale)	—

Measure

Time frame

Measured at pre-discharge using patient records: 1. Time to first flatus 2. Time to first satisfactory breastfeeding experience 3. Time to first urination 4. Time to ambulation 5. VNRS: Satisfaction with allocated compress to your perineal repair site (@24 H) 6. Analgesia used Measured at 14 days after delivery (by telephone): 7. Oral analgesia use for perineal pain 8. VNRS pain score during mobilisation Measured at 6 weeks after delivery (by telephone): 9. Oral analgesia use for perineal pain 10. VNRS pain score during mobilisation 11. Resumption of vagina intercourse 12. Exclusive breastfeeding 13. Perineal healing (Likert scale)

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Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026