NCT04157777

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2011

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

October 15, 2019

Last Update Submit

November 6, 2019

Conditions

Keywords

Perineum massage, perineal trauma,perineal laceration

Outcome Measures

Primary Outcomes (1)

  • 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 .

    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.

    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.

Study Arms (2)

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.

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.

Other: Perineum massage with olive oil

Interventions

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.

controlmassage

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof.

Study Record Dates

First Submitted

October 15, 2019

First Posted

November 8, 2019

Study Start

March 15, 2009

Primary Completion

April 9, 2010

Study Completion

April 16, 2011

Last Updated

November 8, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share