Cold CompressNCT05350670
Effect of Perineal Massage Combined With Cold Compress in the Second Stage on the Delivery Outcome of Primipara
A study testing Perineal massage and cold compress in people with Cold Compress, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
Objective: The aim of this study was to investigate the effect of perineal massage and cold compress in second stage on the delivery outcome of primipara. Method: This interventional study included a total of 200 primipara hoping for natural birth. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cold Compress
- What is being tested?
- Perineal massage and cold compress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- want give birth naturally
- have well developed perineum
Who cannot join
- Abnormal fetal position and head basin
- Severe obstetric complications
About this study
Objective: The aim of this study was to investigate the effect of perineal massage and cold compress in second stage on the delivery outcome of primipara.
Method: This interventional study included a total of 200 primipara hoping for natural birth. Patients were randomly divided into two groups, one group used routine labor, one group used cold compress and perineal massage. Record the time of second stage of labor, degree of perineal laceration, etc.
- Conditions
- Cold Compress
- Being tested
- Perineal massage and cold compress
- Keywords
- the second labor, perineal laceration, perineal massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal massage and cold compressBehavioural
Using perineal massage and cold compress during the second stage of labor to observe the effect
| Study group | Role | What they receive |
|---|---|---|
| perineal massage and cold compress group | Experimental | Not described Receives: Behavioral: Perineal massage and cold compress |
| no intervention group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time of second stage of labor
calculate the time taken for the second stage of labor
Measured: until the end of the second stage of labor
Degree of perineal laceration
The degree of perineal laceration was judged according to the degree of perineal division table
Measured: about 30 minutes after the pregnant woman gives birth
Lateral perineal resection rate
observe whether perineal lateral excision was performed during delivery
Measured: until the end of the second stage of labor
Hospitalization days
observe how long pregnant women stay in the hospital
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold CompressStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350670
- Sponsor's protocol ID
- SAHoWMU-CR2022-07-103
- Status last verified
- Apr 2022
- First submitted
- 9 Mar 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perineal Massage Combined With Cold Compress in the Second Stage on the Delivery Outcome of Primipara
- ClinicalTrials.gov ID
- NCT05350670
- Acronym / sponsor ID
- SAHoWMU-CR2022-07-103
- Conditions
- Cold Compress
- Keywords
- the second labor, perineal laceration, perineal massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: The aim of this study was to investigate the effect of perineal massage and cold compress in second stage on the delivery outcome of primipara.
Method: This interventional study included a total of 200 primipara hoping for natural birth. Patients were randomly divided into two groups, one group used routine labor, one group used cold compress and perineal massage. Record the time of second stage of labor, degree of perineal laceration, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| perineal massage and cold compress group | Experimental | Behavioral: Perineal massage and cold compress |
| no intervention group | No intervention | – |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- want give birth naturally
- have well developed perineum
Key exclusion criteria (2 listed)
- Abnormal fetal position and head basin
- Severe obstetric complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal massage and cold compressUsing perineal massage and cold compress during the second stage of labor to observe the effect | Behavioural | perineal massage and cold compress group |
Primary outcome
the time of second stage of labor
Time frame: until the end of the second stage of labor
calculate the time taken for the second stage of labor
Degree of perineal laceration
Time frame: about 30 minutes after the pregnant woman gives birth
The degree of perineal laceration was judged according to the degree of perineal division table
Lateral perineal resection rate
Time frame: until the end of the second stage of labor
observe whether perineal lateral excision was performed during delivery
Hospitalization days
Time frame: up to 2 weeks
observe how long pregnant women stay in the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal massage and cold compress in people with Cold Compress, run by Second Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time of second stage of labor (time frame: until the end of the second stage of labor). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.