NCT05164926

Brief Summary

Perineal trauma, whether spontaneous or episiotomy, is a condition that affects the quality of life in primiparous women . In women who have experienced perineal trauma, problems such as dyspareunia, urinary and fecal incontinence, and delayed attachment of mother and baby occur in their later lives. Episiotomy, which is applied to reduce perineal trauma, is not recommended today, but it is still widely used.Different techniques such as perineal massage, hot compress, and Ritgen maneuver are applied to reduce perineal trauma. Perineal Massage can be applied together with oil. There are studies in which massage is applied together with oils.St. John's Wort (St. John's Wort) is a plant used in traditional practice in Turkish medicine against ulcers in the gastrointestinal tract, diabetes, jaundice, hepatic and biliary diseases. Antitumoral , antimicrobial , antiviral activities have been demonstrated. St. John's Wort oil can be used orally for dyspeptic complaints, and there is also a way to apply it through the skin. When applied for this purpose, it benefits from its facilitating feature of wound healing. It is useful in wound healing, myalgia and minor bruises, burn pain . The investigators'aim in this study is to investigate the effects of perineal massage with St. John's Wort oil on episiotomy, perineal damage and wound healing.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

November 13, 2021

Last Update Submit

July 30, 2024

Conditions

Keywords

perineal injuryperineal massageSt. John's Wort oilVisual analogue scoringepisiotomy

Outcome Measures

Primary Outcomes (2)

  • Presence of 3rd and 4th degree perineal damage

    The presence of 3rd and 4th degree perineal tears will be recorded by examination immediately after birth.

    5 minutes after birth

  • Visual Analogua Scale

    The scale has 0-10 points.As The point increases the pain score increases

    5 minutes after birth

Secondary Outcomes (4)

  • perineal muscle strength

    postpartum at week 1

  • wound healing-wound color

    postpartum at week 1

  • wound healing-wound inflamation

    postpartum at week 1

  • wound healing-wound heat

    postpartum at week 1

Study Arms (1)

Experimental group, whose perineum was massaged with St. John's Wort oil during labor

EXPERIMENTAL

St. John's Wort oil will be applied to this group during perineal massage during labor.

Other: perineal massage with St. John's Wort oil

Interventions

perineal massage with St. John's Wort oil during labor

Experimental group, whose perineum was massaged with St. John's Wort oil during labor

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal pregnant women
  • active labor during the examination
  • pregnant woman who is likely to have a vaginal delivery

You may not qualify if:

  • Pregnant women with risky pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rahime Bedir Findik

Ankara, Çankaya, 06200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Hypericum extract LI 160

Study Officials

  • Rahime Bedir Findik, Dr

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahime Bedir Findik, Dr

CONTACT

Zuhal Yapıcı Coşkun, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: two groups with St.John's Wort Oil control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr

Study Record Dates

First Submitted

November 13, 2021

First Posted

December 21, 2021

Study Start

May 15, 2023

Primary Completion

October 30, 2024

Study Completion

December 30, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations