Second Stage of LaborNCT00662974
Searching for the Perfect Oil to Protect the Perineum: A Randomized-Controlled, Double-Blind Trial
A study testing perineal massage with Wheat Germ Oil during the second stage of labor and perineal massage with almond oil during the second stage of labor in people with Second Stage of Labor, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
In this study we intend to randomly assign each parturient one of two commonly used oils to be applied during the second stage of labor, one of them containing vitamin E. We will verify if perineal massage increases the chances of delivering with an intact perineum comparing the two oils. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Second Stage of Labor
- What is being tested?
- perineal massage with Wheat Germ Oil during the second stage of labor and perineal massage with almond oil during the second stage of labor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- May 2008to Mar 2009
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Term pregnancy
Who cannot join
- Non-vertex pregnancies
- Multiple pregnancies
- Placenta previa
- Placental abruption
- Intra-uterine infection
- Non progressive labor first stage
- Former operations or surgical procedures in the vagina
- Perineal massage during the weeks before labor
Trial locations and contacts
1 site in 1 country.
Israel1 site
Delivery Room, Soroka University Medical Center
Beersheba
EYAL SHEINER, 972-54-8045074, sheiner@bgu.ac.il
EYAL SHEINER, MD PhD
About this study
Official title: A Randomised Double Blind Clinical Trial to Verify if Perineal Massage Increases the Chances of Delivering With an Intact Perineum Comparing the Two Oils. As Secondary Objective, we Will Evaluate the Effects of Perineal Massage on Specific Tear Location, the Severity of Perineal Tears and the Amount of Suture Material Required for Repair
In this study we intend to randomly assign each parturient one of two commonly used oils to be applied during the second stage of labor, one of them containing vitamin E. We will verify if perineal massage increases the chances of delivering with an intact perineum comparing the two oils. As secondary objectives, we will evaluate the effects of perineal massage on specific tear location, the severity of perineal tears and the amount of suture material required for repair.
- Conditions
- Second Stage of Labor
- Being tested
- perineal massage with Wheat Germ Oil during the second stage of labor, perineal massage with almond oil during the second stage of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineal massage with Wheat Germ Oil during the second stage of laborOther
30 ml of oil applied during labor
perineal massage with almond oil during the second stage of laborOther
30 ml of oil applied during labor
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | parturients during the second stage of labor massaged by Wheat Germ Oil Receives: Other: perineal massage with Wheat Germ Oil during the second stage of labor |
| B | Experimental | parturients during the second stage of labor massaged by almond oil Receives: Other: perineal massage with almond oil during the second stage of labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
perineal tears vs intact perineum
Measured: after delivery
Secondary outcomes (1)
severity of perineal tears amount of suture material required for repair suturing length
Measured: after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Stage of LaborStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662974
- Sponsor's protocol ID
- sor468908ctil
- Status last verified
- Mar 2008
- First submitted
- 17 Apr 2008
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double Blind Clinical Trial to Verify if Perineal Massage Increases the Chances of Delivering With an Intact Perineum Comparing the Two Oils. As Secondary Objective, we Will Evaluate the Effects of Perineal Massage on Specific Tear Location, the Severity of Perineal Tears and the Amount of Suture Material Required for Repair
- ClinicalTrials.gov ID
- NCT00662974
- Acronym / sponsor ID
- sor468908ctil
- Conditions
- Second Stage of Labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 21 Apr 2008 (estimated)
- 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.
In this study we intend to randomly assign each parturient one of two commonly used oils to be applied during the second stage of labor, one of them containing vitamin E. We will verify if perineal massage increases the chances of delivering with an intact perineum comparing the two oils. As secondary objectives, we will evaluate the effects of perineal massage on specific tear location, the severity of perineal tears and the amount of suture material required for repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: perineal massage with Wheat Germ Oil during the second stage of laborparturients during the second stage of labor massaged by Wheat Germ Oil |
| B | Experimental | Other: perineal massage with almond oil during the second stage of laborparturients during the second stage of labor massaged by almond oil |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Term pregnancy
Key exclusion criteria (8 listed)
- Non-vertex pregnancies
- Multiple pregnancies
- Placenta previa
- Placental abruption
- Intra-uterine infection
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 with Wheat Germ Oil during the second stage of labor30 ml of oil applied during labor | Other | A |
| perineal massage with almond oil during the second stage of labor30 ml of oil applied during labor | Other | B |
Primary outcome
perineal tears vs intact perineum
Time frame: after delivery
1 secondary outcome
severity of perineal tears amount of suture material required for repair suturing length
Time frame: after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perineal massage with Wheat Germ Oil during the second stage of labor and perineal massage with almond oil during the second stage of labor in people with Second Stage of Labor, run by Soroka University Medical Center 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 2 inclusion and 8 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 21 Apr 2008. 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 AVI HARLEV, MD (972-50-7434215, harlev@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perineal tears vs intact perineum (time frame: after delivery). 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 21 Apr 2008.