Cold compared with room temperature compress on the perineal repair site following normal vaginal delivery in women who have delivered their first child
| ISRCTN | ISRCTN13570188 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13570188 |
| Secondary identifying numbers | MECID number 2021118-10761 |
- Submission date
- 16/02/2022
- Registration date
- 05/04/2022
- Last edited
- 28/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Vaginal delivery offers many benefits such as a rapid recovery process and an early start to the mother-infant relationship especially in primiparous (first birth) women when it is unfortunately often associated with perineal trauma (any damage to the area between the vagina and the anus during the birth of a baby). Cryotherapy (ice pack application) is a non-pharmacological, non-invasive, low-cost therapy, which reduces local tissue temperature. This localised method results in an anti-inflammatory effect that consequently leads to less swelling and pain.
The objective of this proposed study is to evaluate cold versus room temperature compress (placebo) to the perineal repair site on perineal pain in primiparous women.
Who can participate?
All women aged 18 years old and above, in their first pregnancy and planning on vaginal delivery is eligible to participate in this study. The final inclusion criteria will be determined upon completion of perineal repair.
What does the study involve?
The study involved applying either cold or room temperature compress at the perineal repair site at 3 different points of time: immediately post repair, at 4-hour and 8-hour post delivery. The compress will be placed at the perineum for 20minutes each before it is being discarded.
What are the possible benefits and risks of participating?
The purpose of the trial is to evaluate the trial interventions as there is uncertainty about which is better or they may be equivalent. Information obtained from this study will help guide the management of future patients in similar circumstances. Some women may feel the compress to be uncomfortable. As the compress will be placed at the perineum for 20minutes, patient will have difficulty in sitting or walking but they will be provided with proper disposable panties that can support the compress and make them more comfortable without any extra cost. There is no evidence to show that applying either of this compress will increase risk of perineal wound breakdown.
Where is the study run from?
Department of Obstetrics and Gynaecology, University Malaya Medical Center (Malaysia)
When is the study starting and how long is it expected to run for?
November 2021 to March 2023
Who is funding the study?
Department of Obstetrics and Gynaecology, University Malaya Medical Center (Malaysia)
Who is the main contact?
Dr. Khaliza Kazrin binti Abd Karim, azaareen84@gmail.com
Prof PC Tan, tanpengchiong@yahoo.com
Contact information
Principal Investigator
University Malaya Medical centre
Jalan Professor Ungku Aziz
Kuala Lumpur
59100
Malaysia
 ORCID ID |
0000-0001-8713-6581 |
|---|---|
| Phone | +60 122710429 |
| azaareen84@gmail.com |
Study information
| Study design | Interventional single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | 41184 PIS 2.0 29Jan2021.pdf |
| Scientific title | Cold compared with room temperature compress on the perineal repair site following normal vaginal delivery in primiparous women |
| Study acronym | CROCIP |
| Study objectives | We hypothesized that women randomised to cold compress compared to controls will have - lower pain score when mobilizing post-delivery - lower requirement of oral analgesia - earlier resumption of vagina intercourse |
| Ethics approval(s) | Approved 10/02/2022, Medical Research Ethics Committee of University Malaya Medical Centre (Level 2, Kompleks Pendidikan Sains Kejururawatan, University of Malaya Medical Centre Jalan Professor Ungku Aziz 59100 Kuala Lumpur, Malaysia; +603-7949 3209/2251; ummc-mrec@ummc.edu.my), ref: 2021118-10761 |
| Health condition(s) or problem(s) studied | Supportive care for perineal wound sustained in primiparous women during normal vaginal delivery. |
| Intervention | 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 room temperature) - control group The allocated pack will be placed against the sutured site of the perineum for 20 min at 3 different time points: immediately after repair, at 4 h after repair, and 8 h after repair. Analgesia: Stat dose of 1 g paracetamol po after perineal repair then 1 g paracetamol po qds prn. If breakthrough pain, escalation to 400 mg ibuprofen po qds. Further escalation at care providers’ discretion At discharge 1 g paracetamol po qds prn or if moderate pain, 400 mg ibuprofen po qds prn with 3 days’ supply. Further escalation at care providers’ discretion Randomization: Randomization sequence generated in random blocks of 4 or 8 with within block randomization using https://www.sealedenvelope.com/simple-randomiser/v1/lists by an investigator not involved in recruitment. The randomization sequence is concealed in numbered, sealed opaque envelopes. Randomization is by opening the lowest-numbered envelope remaining for the newest recruit. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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) |
| Overall study start date | 05/11/2021 |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 222 (111 in each arm) |
| Total final enrolment | 224 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/05/2022 |
| Date of final enrolment | 07/02/2023 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Department of Obstetrics and Gynaecology
Jalan Professor Ungku Aziz
Kuala Lumpur
59100
Malaysia
| Phone | +60 37949 3209/2251 |
|---|---|
| ummc@ummc.edu.my |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Data sharing statement to be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 29/01/2021 | 21/02/2022 | No | Yes | |
| Results article | 24/12/2023 | 28/12/2023 | Yes | No |
Additional files
Editorial Notes
28/12/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
04/04/2023: The following updates have been made to the study record and the plain English summary updated accordingly:
1. The recruitment start date has been changed from 30/04/2022 to 09/05/2022.
2. The recruitment end date has been changed from 30/10/2022 to 07/02/2023.
3. The overall trial end date has been changed from 31/05/2023 to 31/03/2023.
4. The intention to publish date has been changed from 31/10/2023 to 31/03/2024.
21/02/2022: Trial's existence confirmed by University Malaya Medical Centre
