Perineum; TearNCT05851170
Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears
A study testing The use of warm compresses and almond oil on the perineum during second stage and Use of almond oil use (routine care) during second stage in people with Perineum; Tear, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
There is a controversy regarding whether warm compresses influence the rate of intact perineum after a vaginal delivery. According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineum; Tear
- What is being tested?
- The use of warm compresses and almond oil on the perineum during second stage and Use of almond oil use (routine care) during second stage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Jun 2023to 1 Jun 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Term pregnancy
- Singleton pregnancy
- Vertex presentation
Who cannot join
- Women with a history of third degree perineal tear in the past
- Intrauterine fetal death
- Crohn disease with perineal involvement
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Galilee Medical Center
Nahariya, Northern District
Amal Shahen, amals@gmc.gov.il
About this study
Official title: Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears: a Randomized Controlled Trial
There is a controversy regarding whether warm compresses influence the rate of intact perineum after a vaginal delivery.
According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies.
Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.
Read the detailed description
Various techniques have been developed to prevent the development of perineal tears. As reported in the literature, active protection of the perineum during the second stage of labor can reduce the rate of tears. These include massage of the perineum, hands-on technique, use of gel, and warm compresses.
According to a Cochrane review that examined the use of warm compresses published in 2017, there is no difference in terms of the rate of events of an intact perineum, perineal trauma that requires suturing, but in a subanalysis it showed that there is a decrease in the rate of advanced tears, involving the anal sphincter and the rectal mucosa (grade three and four).
According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies.
Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.
- Conditions
- Perineum; Tear
- Being tested
- The use of warm compresses and almond oil on the perineum during second stage, Use of almond oil use (routine care) during second stage
- Keywords
- Perineal tear, Warm compresses, Intact perineum, Almond oil
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The use of warm compresses and almond oil on the perineum during second stageOther
Also called Experimental
Hot water from the tap at a temperature of (45-590c) will be poured into a container, and will be changed every 15 minutes.
Timing of the start: when the baby's head descends in the pelvic canal and the woman feels the need to push The intervention: warm compresses will be attached to the perineum between the pressures During the pressing - almond oil will be applied. Meanwhile, the compresses will be returned to a bowl containing hot water. Every 15 minutes until birth the water will be replaced with hot water at an initial temperature of 45-590c.
It is necessary to use compresses for a minimum of 10 minutes, and a maximum of 30 minutes.
Use of almond oil use (routine care) during second stageOther
Also called Routine care
Routine care in the department is the use of almond oil during the second stage of pregnancy, during pushing.
| Study group | Role | What they receive |
|---|---|---|
| Use of warm compresses and almond oil use during the second stage | Experimental | Warm compresses will be attached to the perineum between pushing During active pushing - almond oil will be used on the perineum (our routine care). Receives: Other: The use of warm compresses and almond oil on the perineum during second stage |
| Use of almond oil use (routine care) during the second stage | Active comparator | During active pushing - almond oil will be applied on the perineum Receives: Other: Use of almond oil use (routine care) during second stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with perineal tear
Perineal tear (spontaneous) that required suturing
Measured: 2 years
Secondary outcomes (3)
Number of patients with episiotomy
The rate of episiotomy
Measured: 2 years
Number of patients with mild perineal tear
First and second degree
Measured: 2 years
Number of patients with with advanced perineal tear
Third and fourth degree
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start11 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perineum; TearStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Raneen Abu Shqara, Western Galilee Hospital-Nahariya
- Investigators
- Raneen Abu Shqara, MD, Principal investigator, Galilee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851170
- Sponsor's protocol ID
- NHR-0198-22
- Status last verified
- Jun 2023
- First submitted
- 28 Apr 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.
PubMed 28608597Magoga G, Saccone G, Al-Kouatly HB, Dahlen G H, Thornton C, Akbarzadeh M, Ozcan T, Berghella V. Warm perineal compresses during the second stage of labor for reducing perineal trauma: A meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:93-98. doi: 10.1016/j.ejogrb.2019.06.011. Epub 2019 Jun 15.
PubMed 31238205Pierce-Williams RAM, Saccone G, Berghella V. Hands-on versus hands-off techniques for the prevention of perineal trauma during vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2021 Mar;34(6):993-1001. doi: 10.1080/14767058.2019.1619686. Epub 2019 Jun 3.
PubMed 31092083Geranmayeh M, Rezaei Habibabadi Z, Fallahkish B, Farahani MA, Khakbazan Z, Mehran A. Reducing perineal trauma through perineal massage with vaseline in second stage of labor. Arch Gynecol Obstet. 2012 Jan;285(1):77-81. doi: 10.1007/s00404-011-1919-5. Epub 2011 May 26.
PubMed 21614497
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05851170
- Acronym / sponsor ID
- NHR-0198-22
- Conditions
- Perineum; Tear
- Keywords
- Perineal tear, Warm compresses, Intact perineum, Almond oil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 11 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 9 May 2023 (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.
There is a controversy regarding whether warm compresses influence the rate of intact perineum after a vaginal delivery.
According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies.
Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.
Detailed description
Various techniques have been developed to prevent the development of perineal tears. As reported in the literature, active protection of the perineum during the second stage of labor can reduce the rate of tears. These include massage of the perineum, hands-on technique, use of gel, and warm compresses.
According to a Cochrane review that examined the use of warm compresses published in 2017, there is no difference in terms of the rate of events of an intact perineum, perineal trauma that requires suturing, but in a subanalysis it showed that there is a decrease in the rate of advanced tears, involving the anal sphincter and the rectal mucosa (grade three and four).
According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies.
Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Use of warm compresses and almond oil use during the second stage | Experimental | Other: The use of warm compresses and almond oil on the perineum during second stageWarm compresses will be attached to the perineum between pushing During active pushing - almond oil will be used on the perineum (our routine care). |
| Use of almond oil use (routine care) during the second stage | Active comparator | Other: Use of almond oil use (routine care) during second stageDuring active pushing - almond oil will be applied on the perineum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Term pregnancy
- Singleton pregnancy
- Vertex presentation
Key exclusion criteria (3 listed)
- Women with a history of third degree perineal tear in the past
- Intrauterine fetal death
- Crohn disease with perineal involvement
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 |
|---|---|---|
| The use of warm compresses and almond oil on the perineum during second stageAlso: ExperimentalHot water from the tap at a temperature of (45-590c) will be poured into a container, and will be changed every 15 minutes. Timing of the start: when the baby's head descends in the pelvic canal and the woman feels the need to push The intervention: warm compresses will be attached to the perineum between the pressures During the pressing - almond oil will be applied. Meanwhile, the compresses will be returned to a bowl containing hot water. Every 15 minutes until birth the water will be replaced with hot water at an initial temperature of 45-590c. It is necessary to use compresses for a minimum of 10 minutes, and a maximum of 30 minutes. | Other | Use of warm compresses and almond oil use during the second stage |
| Use of almond oil use (routine care) during second stageAlso: Routine careRoutine care in the department is the use of almond oil during the second stage of pregnancy, during pushing. | Other | Use of almond oil use (routine care) during the second stage |
Primary outcome
Number of patients with perineal tear
Time frame: 2 years
Perineal tear (spontaneous) that required suturing
3 secondary outcomes
Number of patients with episiotomy
Time frame: 2 years
Number of patients with mild perineal tear
Time frame: 2 years
Number of patients with with advanced perineal tear
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 28608597Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.
- Background: PubMed 31238205Magoga G, Saccone G, Al-Kouatly HB, Dahlen G H, Thornton C, Akbarzadeh M, Ozcan T, Berghella V. Warm perineal compresses during the second stage of labor for reducing perineal trauma: A meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:93-98. doi: 10.1016/j.ejogrb.2019.06.011. Epub 2019 Jun 15.
- Background: PubMed 31092083Pierce-Williams RAM, Saccone G, Berghella V. Hands-on versus hands-off techniques for the prevention of perineal trauma during vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2021 Mar;34(6):993-1001. doi: 10.1080/14767058.2019.1619686. Epub 2019 Jun 3.
- Background: PubMed 21614497Geranmayeh M, Rezaei Habibabadi Z, Fallahkish B, Farahani MA, Khakbazan Z, Mehran A. Reducing perineal trauma through perineal massage with vaseline in second stage of labor. Arch Gynecol Obstet. 2012 Jan;285(1):77-81. doi: 10.1007/s00404-011-1919-5. Epub 2011 May 26.
- Individual participant dataSharing planned: Undecided
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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.
Raneen Abu Shqara, MD principal investigator
Galilee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The use of warm compresses and almond oil on the perineum during second stage and Use of almond oil use (routine care) during second stage in people with Perineum; Tear, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 3 inclusion and 3 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 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Raneen Abu Shqara, MD (+972549793591, rabushqara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with perineal tear (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851170, which also lists 4 linked publications.
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 29 Jun 2023.