PreventionNCT04157777
THE EFFECT OF PERİNEUM MASSAGE WİTH OLİVE OİL ON PERİNEUM INTEGRİTY AND DURATİON OF SECOND PERİOD OF DELİVERY
A study testing Perineum massage with olive oil in people with Prevention, run by TC Erciyes University.
Trial summary
Aims and objectives:This experimental study was conducted to determine the effect of perineum massage with olive oil performed in the second period of the delivery on travay duration, episiotomy requirement and perineum tears in term pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prevention
- What is being tested?
- Perineum massage with olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2009to 16 Apr 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who had cephalic presentation
- with vertex presentation
- alive primiparous pregnancy at 38-40thgestational weeks (according to last menstruation date or ultrasonography determination)
- They also did not have any cesarean or any kind of uterine surgical operation
- aged between 17 and 40
- with no risk factors (heart disease, placenta praevia, oligohydramnios, preeclampsia, anhydramnios, diabetes, epilepsy), multiparous≤ three times, literate and without counter indication for vaginal birth were included in the research.
Who cannot join
- history of any cesarean operation or uterus surgery
- dead fetus, vaginal bleeding with no explanation
- twin pregnancy
- presence of fetal anomaly
- estimated fetal weight over 4500 gr. as determined by ultrasonography and presence of presentation anomaly.
About this study
Official title: THE EFFECT OF PERİNEUM MASSAGE WİTH OLİVE OİL
Aims and objectives:This experimental study was conducted to determine the effect of perineum massage with olive oil performed in the second period of the delivery on travay duration, episiotomy requirement and perineum tears in term pregnant women.
Background: Perineal trauma that may occur during labor may pose a critical risk both for mother's health and her quality of life.
Read more
Design: A randomized controlled trial. This study adhered to CONSORT 2010 checklist guidelines for qualitative research reporting Method: Among women who applied to Maternity Hospital 350 pregnant women were assigned to massage group while other 350 were to control group. Participants in both groups filled out an information form including socio-demographic characteristics. Perineum massage with olive oil in the second period of delivery was performed to massage group. In the control group, no other interventions except for applications performed routinely in the delivery room were done.
Results: Episiotomy was done in 34.3% of massage group while in 48.6% of control group. Percentage of being performed episiotomy in the massage group significantly decreased (p<0.05).Tear appeared in 17.7% of the massage group while in 38.0% of the controls. Percentage of tear formation in the massage group significantly decreased (p<0.05). No statistically significant difference was found between the second period of the delivery of massage and control group. All of the pregnant women in the massage group and midwives who performed massage were satisfied with perineum massage with olive oil in the delivery and stated that they would suggest and perform this application Conclision: Regarding the results of this study and those of other studies, perineal massage during the second stage of labor can reduce the need for episiotomy, and avoid perineal injuries, and perineal pain.
This study provides useful information to clinician and researchers when determining practices such as postnatal standing up in early period,reduced episiotomy requirement, mother's health ,her quality of life, shorter hospital stay and perineal trauma.
What does this paper contribute to the wider global clinical community?
- Perineum massage performed with olive oil in delivery are an effective, inexpensive, simple, and well-tolerated way to improve intact perineum..
- Perineum massage performed with olive oil in delivery are safe and associated with mother's health and her quality of life and shorter hospital stay.
Read the detailed description
The idea that birth process should be undergone minimal intervention has been spreading. Unlike the abovementioned idea, the fact that episiotomy practice -especially on the primiparous pregnant women- has almost been a routine in Turkey and it has been practiced -even if it is not necessary- despite the fact that itprolongs the post-partum healing and increases perineum trauma risks.
Perineal trauma is described as the damage that occurs spontaneously or due to a surgical incision or episiotomy during the labor in the genital region. Perineal trauma that may occur during labor may pose a critical risk both for mother's health and her quality of life. Perineal trauma is accompanied with short term or long term morbidity during and after birth and affects sexuality and physical image of the women negatively. Some of these effects are painful sexual intercourse, fecal and urinary incontinence and continuous perineal pain.
Perineal massage performed by using an oily substance that has lubricant properties is described as the massage made on the muscles around the vagina and its tissues. The massage,which is thought to haveimportant effects onelasticity of the tissues and muscles and the rehabilitation is thought to provide benefits for vaginal births due to the similar useful effects on the tissues and muscles around the perineal. Perineal massage with lubricant is a poten-tial therapeutic approach implemented at the second stage of delivery.
Background Perineal tissues should be pulled aside to allow the neonate exit from the vagina.Studies regarding the perineal pulling and massaging in the second stage of labor for relaxing the perineum and possibly preventing perineal laceration and episiotomy, have concluded that the perineal pulling and massaging increase possibility of childbirth with an intact perineum. Perineal massage increases elasticity and blood supply to the perineum and leads to easier pulling and less pain during childbirth. It also reduces the possibility of perineal laceration, the need to episiotomy, and postpartum perineal pain.
Aims:
The aim of the present research was to determine the effects of massage performed by using olive oil on travail duration, episiotomy requirement and perineal tears for the term pregnancies during second stage of the labor.
COLLOUT: Perineal trauma that may occur during labor may pose a critical risk both for mother's health and her quality of life.
- Conditions
- Prevention
- Being tested
- Perineum massage with olive oil
- Keywords
- Perineum massage, perineal trauma,perineal laceration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineum massage with olive oilOther
Descriptive form used for data collection included questions about women's sociodemographic features, medical and obstetric history and previous and present birthsof women participated in the study.
The Reeda Scale The scale is consisted of five parameters of healing: Redness, Edema, Ecchymosis, Discharge Approximation.
Pregnant women who came to the delivery room and met the criteria were randomly selected and assigned to experimental and control group according to age and educational status.
There was not any change in the birth process of the delivery room during data collection and the pregnant women received routine care and treatments.
REEDA scale was administered by other midwives who worked at the puerperal room where pregnant women stayed after birth and did not know their groups because those who gave vaginal birth were early discharged from the hospital as they could answer only the first three parameters of REEDA scale.
| Study group | Role | What they receive |
|---|---|---|
| massage | Experimental | Among women who applied to Maternity Hospital 350 pregnant women were assigned to massage group. Participants in massage group filled out an information form including socio-demographic characteristics. Perineum massage with olive oil in the second period of delivery was performed to massage group.In massage group when they progressed to full dilatation of the cervix, the midwife inserted two fingers inside vagina and using a sweeping motion gently stretched the perineum with lubricant 5 up to 10 minutes, in and between mother's pushing in the second stage of labour. Receives: Other: Perineum massage with olive oil |
| control | Experimental | Among women who applied to Maternity Hospital 350 pregnant women were assigned to control group. Participants in control group filled out an information form including socio-demographic characteristics.And, no other interventions except for applications performed routinely in the delivery room were done.In control group just Ritgen Maneuver was applied. At last, we com-pared the rate of intact perineum, episiotomy and laceration, mean duration of the second stage of labor and Apgar score in 1 and 5 minutes be-tween two groups. Receives: Other: Perineum massage with olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
episiotomy requirement and perineal tears for the term pregnancies
Perineal massage performed byusing an oily substance that has lubricant properties is described as the massage made on the muscles around the vagina and its tissues. The massage,which is thought to haveimportant effects onelasticity of the tissues and muscles and the rehabilitation is thought to provide benefits for vaginal births due to the similar useful effects on the tissues and muscles around the perineal3-6.The aim of the present research was to determine the effects of massage performed by using olive oil on travail duration, episiotomy requirement and perineal tears for the term pregnancies .
Measured: The midwives were told to perform the massage after the pregnant woman was placed in the obstetric table and her cervical dilatation was between 7 and 10 cm.
Secondary outcomes (1)
during second stage of the labor.
Perineal massage performed byusing an oily substance that has lubricant properties is described as the massage made on the muscles around the vagina and its tissues. The massage,which is thought to haveimportant effects onelasticity of the tissues and muscles and the rehabilitation is thought to provide benefits for vaginal births due to the similar useful effects on the tissues and muscles around the perineal.The aim of the present research was to determine the effects of massage performed by using olive oil on travail duration, episiotomy requirement and perineal tears for the term pregnancies during second stage of the labor.
Measured: The midwives were told to perform the massage after the pregnant woman was placed in the obstetric table and her cervical dilatation was between 7 and 10 cm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start15 Mar 2009
- Primary completion9 Apr 2010
- Study completion16 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evrim Bayraktar, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157777
- Sponsor's protocol ID
- Erciyes U
- Status last verified
- Nov 2019
- First submitted
- 15 Oct 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF PERİNEUM MASSAGE WİTH OLİVE OİL
- ClinicalTrials.gov ID
- NCT04157777
- Acronym / sponsor ID
- Erciyes U
- Conditions
- Prevention
- Keywords
- Perineum massage, perineal trauma,perineal laceration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Mar 2009 (actual)
- Primary completion
- 9 Apr 2010 (actual)
- Study completion
- 16 Apr 2011 (actual)
- First posted
- 8 Nov 2019 (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.
Aims and objectives:This experimental study was conducted to determine the effect of perineum massage with olive oil performed in the second period of the delivery on travay duration, episiotomy requirement and perineum tears in term pregnant women.
Background: Perineal trauma that may occur during labor may pose a critical risk both for mother's health and her quality of life.
Design: A randomized controlled trial. This study adhered to CONSORT 2010 checklist guidelines for qualitative research reporting Method: Among women who applied to Maternity Hospital 350 pregnant women were assigned to massage group while other 350 were to control group. Participants in both groups filled out an information form including socio-demographic characteristics. Perineum massage with olive oil in the second period of delivery was performed to massage group. In the control group, no other interventions except for applications performed routinely in the delivery room were done.
Results: Episiotomy was done in 34.3% of massage group while in 48.6% of control group. Percentage of being performed episiotomy in the massage group significantly decreased (p<0.05).Tear appeared in 17.7% of the massage group while in 38.0% of the controls. Percentage of tear formation in the massage group significantly decreased (p<0.05). No statistically significant difference was found between the second period of the delivery of massage and control group. All of the pregnant women in the massage group and midwives who performed massage were satisfied with perineum massage with olive oil in the delivery and stated that they would suggest and perform this application Conclision: Regarding the results of this study and those of other studies, perineal massage during the second stage of labor can reduce the need for episiotomy, and avoid perineal injuries, and perineal pain.
This study provides useful information to clinician and researchers when determining practices such as postnatal standing up in early period,reduced episiotomy requirement, mother's health ,her quality of life, shorter hospital stay and perineal trauma.
What does this paper contribute to the wider global clinical community?
- Perineum massage performed with olive oil in delivery are an effective, inexpensive, simple, and well-tolerated way to improve intact perineum..
- Perineum massage performed with olive oil in delivery are safe and associated with mother's health and her quality of life and shorter hospital stay.
Detailed description
The idea that birth process should be undergone minimal intervention has been spreading. Unlike the abovementioned idea, the fact that episiotomy practice -especially on the primiparous pregnant women- has almost been a routine in Turkey and it has been practiced -even if it is not necessary- despite the fact that itprolongs the post-partum healing and increases perineum trauma risks.
Perineal trauma is described as the damage that occurs spontaneously or due to a surgical incision or episiotomy during the labor in the genital region. Perineal trauma that may occur during labor may pose a critical risk both for mother's health and her quality of life. Perineal trauma is accompanied with short term or long term morbidity during and after birth and affects sexuality and physical image of the women negatively. Some of these effects are painful sexual intercourse, fecal and urinary incontinence and continuous perineal pain.
Perineal massage performed by using an oily substance that has lubricant properties is described as the massage made on the muscles around the vagina and its tissues. The massage,which is thought to haveimportant effects onelasticity of the tissues and muscles and the rehabilitation is thought to provide benefits for vaginal births due to the similar useful effects on the tissues and muscles around the perineal. Perineal massage with lubricant is a poten-tial therapeutic approach implemented at the second stage of delivery.
Background Perineal tissues should be pulled aside to allow the neonate exit from the vagina.Studies regarding the perineal pulling and massaging in the second stage of labor for relaxing the perineum and possibly preventing perineal laceration and episiotomy, have concluded that the perineal pulling and massaging increase possibility of childbirth with an intact perineum. Perineal massage increases elasticity and blood supply to the perineum and leads to easier pulling and less pain during childbirth. It also reduces the possibility of perineal laceration, the need to episiotomy, and postpartum perineal pain.
Aims:
The aim of the present research was to determine the effects of massage performed by using olive oil on travail duration, episiotomy requirement and perineal tears for the term pregnancies during second stage of the labor.
COLLOUT: Perineal trauma that may occur during labor may pose a critical risk both for mother's health and her quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| massage | Experimental | Other: Perineum massage with olive oilAmong women who applied to Maternity Hospital 350 pregnant women were assigned to massage group. Participants in massage group filled out an information form including socio-demographic characteristics. Perineum massage with olive oil in the second period of delivery was performed to massage group.In massage group when they progressed to full dilatation of the cervix, the midwife inserted two fingers inside vagina and using a sweeping motion gently stretched the perineum with lubricant 5 up to 10 minutes, in and between mother's pushing in the second stage of labour. |
| control | Experimental | Other: Perineum massage with olive oilAmong women who applied to Maternity Hospital 350 pregnant women were assigned to control group. Participants in control group filled out an information form including socio-demographic characteristics.And, no other interventions except for applications performed routinely in the delivery room were done.In control group just Ritgen Maneuver was applied. At last, we com-pared the rate of intact perineum, episiotomy and laceration, mean duration of the second stage of labor and Apgar score in 1 and 5 minutes be-tween two groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women who had cephalic presentation
- with vertex presentation
- alive primiparous pregnancy at 38-40thgestational weeks (according to last menstruation date or ultrasonography determination)
- They also did not have any cesarean or any kind of uterine surgical operation
- aged between 17 and 40
Key exclusion criteria (5 listed)
- history of any cesarean operation or uterus surgery
- dead fetus, vaginal bleeding with no explanation
- twin pregnancy
- presence of fetal anomaly
- estimated fetal weight over 4500 gr. as determined by ultrasonography and presence of presentation anomaly.
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 |
|---|---|---|
| Perineum massage with olive oilDescriptive form used for data collection included questions about women's sociodemographic features, medical and obstetric history and previous and present birthsof women participated in the study. The Reeda Scale The scale is consisted of five parameters of healing: Redness, Edema, Ecchymosis, Discharge Approximation. Pregnant women who came to the delivery room and met the criteria were randomly selected and assigned to experimental and control group according to age and educational status. There was not any change in the birth process of the delivery room during data collection and the pregnant women received routine care and treatments. REEDA scale was administered by other midwives who worked at the puerperal room where pregnant women stayed after birth and did not know their groups because those who gave vaginal birth were early discharged from the hospital as they could answer only the first three parameters of REEDA scale. | Other | control, massage |
Primary outcome
episiotomy requirement and perineal tears for the term pregnancies
Time frame: The midwives were told to perform the massage after the pregnant woman was placed in the obstetric table and her cervical dilatation was between 7 and 10 cm.
Perineal massage performed byusing an oily substance that has lubricant properties is described as the massage made on the muscles around the vagina and its tissues. The massage,which is thought to haveimportant effects onelasticity of the tissues and muscles and the rehabilitation is thought to provide benefits for vaginal births due to the similar useful effects on the tissues and muscles around the perineal3-6.The aim of the present research was to determine the effects of massage performed by using olive oil on travail duration, episiotomy requirement and perineal tears for the term pregnancies .
1 secondary outcome
during second stage of the labor.
Time frame: The midwives were told to perform the massage after the pregnant woman was placed in the obstetric table and her cervical dilatation was between 7 and 10 cm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: No
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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.
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 Perineum massage with olive oil in people with Prevention, run by TC Erciyes 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 8 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
episiotomy requirement and perineal tears for the term pregnancies (time frame: The midwives were told to perform the massage after the pregnant woman was placed in the obstetric table and her cervical dilatation was between 7 and 10 cm.). 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 8 Nov 2019.