NCT07012278

Brief Summary

Cesarean section refers to the surgical procedure in which the fetus is delivered via an incision, typically performed when vaginal delivery is not possible due to high-risk conditions. In recent years, the rate of cesarean deliveries has increased significantly. The quality of treatment and care is crucial in ensuring proper surgical wound healing following cesarean birth. Various new methods and products have been developed for wound healing and care in recent years, some of which are derived from herbal sources. The limitations of pharmacological methods used in the postpartum period, such as treatment failure, concerns about potential harm to the mother and infant, adverse side effects, negative impact on breastfeeding, emergence of resistant microorganisms, and ineffectiveness of current antibiotics, have led individuals to seek alternative natural remedies. Hypericum perforatum (commonly known as St. John's Wort) is frequently used in the postpartum period due to its antimicrobial and antioxidant properties. This study aims to examine the effects of Hypericum perforatum on wound healing and pain in women following cesarean delivery.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

June 25, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

June 10, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 30, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

Caesarean sectionwound healingpainSt. John's wort oil

Outcome Measures

Primary Outcomes (3)

  • pre-test post-test

    In the first follow-up, a dressing will be made with St. John's wort oil and the woman will be told how to make a dressing with this oil. It will be explained to the woman to make a dressing with St. John's wort oil at the incision site once a day every day. The incision site will be photographed for women who give permission.

    6 months

  • pre-test post-test

    On the 15th day, which is the second follow-up, the wound site will be evaluated by the researcher. The incision site of the women who give permission will be photographed. She will be told to continue the application of St. John's wort oil.

    6 months

  • pre-test post-test

    The third follow-up will be performed on the 25th postpartum day. REEDA Scale and NRS Scale will be applied. REEDA Scale: REEDA scale is used in the evaluation of episiotomy and cesarean incision wounds. The REEDA scale was developed by Davidson in 1970 and used in his master's thesis on the monitoring of wound healing in the perineum. The validity and reliability study of the scale was conducted by Hill in 1990. In Turkey, the validity and reliability study of the REEDA Scale was conducted by Üstünsöz and used in her master's thesis titled "The Effect of Hot and Cold Applications in Episiotomy Healing". The scale has five sub-dimensions: redness, edema, ecchymosis, discharge and approximation of wound edges. Each sub-dimension of the scale is graded using a 4 (four) point Likert-type rating. The evaluation is made between 0-3. The sum of the scale score varies between 0-15. The higher the scale score, the worse the wound healing.

    6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

At the first follow-up, wound dressing will be performed using St. John's Wort oil, and participants will be instructed on how to apply the dressing themselves. They will be advised to apply the oil to the incision site once daily. With the participant's consent, photographs of the incision area will be taken. At the second follow-up, on postpartum day 15, the incision site will be evaluated by the researcher. With consent, photographs of the incision site will again be taken. Participants will be instructed to continue applying the oil daily. The third follow-up will take place on postpartum day 25, during which the REEDA Scale and the Numeric Rating Scale (NRS) will be administered to assess wound healing and pain.

Other: Caesarean section scar dressing with St. John's wort oil

control

NO INTERVENTION

No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group.

Interventions

Dressing the incision site with St. John's wort oil once a day every day

Experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the research,
  • Having had a cesarean section,
  • Her first cesarean section,
  • Being fluent in Turkish.

You may not qualify if:

  • Not wanting to participate in the research,
  • The existence of a communication barrier.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Üniversity

Sakarya, 54000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bilge Nur Yıldırım Bayraktar, PhD

    sakarya üniversity

    STUDY CHAIR
  • Kevser İLÇİOĞLU Associate Professor, PhD

    sakarya üniversity

    STUDY DIRECTOR

Central Study Contacts

Bilge Nur Yıldırım Bayraktar Dr., PhD

CONTACT

Güleser ADA Dr, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Dr.

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 10, 2025

Study Start

June 25, 2025

Primary Completion

December 30, 2025

Study Completion

April 30, 2026

Last Updated

June 10, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations