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NCT04157777
THE EFFECT OF PERİNEUM MASSAGE WİTH OLİVE OİL ON PERİNEUM INTEGRİTY AND DURATİON OF SECOND PERİOD OF DELİVERY
NA trial testing Perineum massage with olive oil in Prevention in 700 participants. Completed in 16 April 2011.
9 April 2010
Quick facts
| Lead sponsor | TC Erciyes University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 700 |
| Start date | 15 March 2009 |
| Primary completion | 9 April 2010 |
| Estimated completion | 16 April 2011 |
Drugs / interventions tested
- Perineum massage with olive oil
Conditions studied
- Prevention — all drugs for Prevention →
Sponsor
TC Erciyes University
Who can join
18 and older, female only, with Prevention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04157777
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04157777 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TC Erciyes University
- Last refreshed: 8 November 2019
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