Cesarean SectionNCT05223127
Aloe Vera on Caesarean Section Wound
A study testing Aloe vera in people with Cesarean Section, run by KTO Karatay University.
Trial summary
Conducting clinical research in line with the literature recommendation, with a method that is low-cost, accessible, easy-to-use, and examined in an evidence-based design related to cesarean section wound, which negatively affects the quality of life of women in the postpartum period, constitutes the original value… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Aloe vera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the age range of 18-35,
- Primiparous,
- Gestational week 37 and above,
- Transver incision made,
- Women who volunteered to participate in the study
Who cannot join
- Body mass index not in the range of 18.5-24.9,
- Having pregnancy complications (such as preeclampsia and diabetes),
- Having chronic diseases (such as anemia, coagulopathy, cardiovascular diseases and respiratory and kidney diseases),
- Smoking or substance use,
- Those who use drugs that affect wound healing (glucocorticoids, anticoagulants, immunosuppressants, antibiotics and chemotherapy drugs before cesarean section),
- Postpartum fever (≥38 ◦C),
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- Conditions that cause excessive stretching of the uterus (multiple pregnancy, polyhydramnios),
- Self or baby in need of intensive care,
- Having had a hysterectomy or myomectomy during the operation,
- The operation takes more than 90 minutes,
- Individuals who do not want to withdraw from the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Aloe Vera on Caesarean Section Wound Healing: Randomized Controlled Study
Conducting clinical research in line with the literature recommendation, with a method that is low-cost, accessible, easy-to-use, and examined in an evidence-based design related to cesarean section wound, which negatively affects the quality of life of women in the postpartum period, constitutes the original value and our main motivation of the project.
Read the detailed description
Cesarean section is the delivery of the fetus by incision in the abdominal and uterine wall and is a life-saving method when certain complications arise. While it was initially performed to take the baby alive from the mother who was about to die, it has become an easier operation with the developments in the field of surgery and anesthesia. In this direction, it has become a viable operation even at the request of the mother. However, there is no evidence of benefit to the mother or baby when applied when it is not necessary. In this direction, although the "ideal cesarean section rate" targeted by the World Health Organization since 1985 is between 10-15%, this rate is 37% in 2008, 48% in 2013 and 52% in 2018, according to Turkey Demographic and Health Research (TNSA) data. reported as. This situation brings many problems related to the postpartum period.
Cesarean section is a surgical intervention, not a form of delivery, and as with any surgical intervention, there are many risks. Moreover, the most important difference of cesarean section from any surgical intervention is that the fetus/newborn is also exposed to these risks. In addition, discomfort can be seen depending on the surgical procedure and the incision site after the cesarean section. In the study conducted to examine the cesarean section experiences and post-cesarean care needs of post-natal women; It is stated that almost all puerperant women have problems due to cesarean section, and pain is the leading problem, followed by pain, difficulty in movement, breastfeeding problem due to the incision site, gas, numbness and contraction while walking. It is stated that women who have had cesarean section most frequently experience problems related to their self-care in the early postpartum period, such as pain at the surgery site, difficulty in moving, gas formation, feeding and defecation. If these problems that occur in the mother during the postpartum period are not detected in a timely manner and are not intervened effectively, they can become chronic and negatively affect both the quality of life of the mothers and the health of the newborn.
Aloe vera is seen as an environmentally friendly traditional wound healing agent that increases collagen content and improves cross-links. It contains healing and moisturizing properties with its anti-inflammatory, antiviral, antibacterial, antifungal, antimicrobial properties. When the literature is examined, in the study on the use of aloe vera in cesarean wound healing; It is stated that no side effects of aloe vera gel were observed, the wound healing rate was higher in the first 24 hours in the intervention group, and there was no significant difference between the wound healing scores of the two groups at the end of the 8th day. However, it is recommended to conduct studies with longer interventions on the subject.
- Conditions
- Cesarean Section
- Being tested
- Aloe vera
- Keywords
- Aloe, Cesarean Section, Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe veraOther
The leaves of Aloe vera (Aloe barbadensis) will be identified and verified by Selçuk University Faculty of Agriculture. Aloe vera leaves will be washed with antiseptic solution and cut crosswise using gloves and sterile knife. The thick epidermis will be removed from the middle of the leaf. The gel will be obtained from the parenchyma of the thick juicy leaves of aloe vera.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Aloe vera Receives: Other: Aloe vera |
| Control group | No intervention | routine care (dressing with dry gauze) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
It will be assessed using the REEDA scale.
Measured: 12 hours
Secondary outcomes (2)
Ache
It will be assessed using the McGill Pain Scale Short Form.
Measured: 12 hours
Life quality
It will be assessed using the SF-36 Quality of Life Scale.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Aug 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hediye Karakoç, KTO Karatay University
- Investigators
- Hediye KARAKOC, PhD, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223127
- Sponsor's protocol ID
- Karatay
- Status last verified
- Nov 2023
- First submitted
- 24 Jan 2022
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aloe Vera on Caesarean Section Wound Healing: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05223127
- Acronym / sponsor ID
- Karatay
- Conditions
- Cesarean Section
- Keywords
- Aloe, Cesarean Section, Wound Healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 3 Feb 2022 (actual)
- 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.
Conducting clinical research in line with the literature recommendation, with a method that is low-cost, accessible, easy-to-use, and examined in an evidence-based design related to cesarean section wound, which negatively affects the quality of life of women in the postpartum period, constitutes the original value and our main motivation of the project.
Detailed description
Cesarean section is the delivery of the fetus by incision in the abdominal and uterine wall and is a life-saving method when certain complications arise. While it was initially performed to take the baby alive from the mother who was about to die, it has become an easier operation with the developments in the field of surgery and anesthesia. In this direction, it has become a viable operation even at the request of the mother. However, there is no evidence of benefit to the mother or baby when applied when it is not necessary. In this direction, although the "ideal cesarean section rate" targeted by the World Health Organization since 1985 is between 10-15%, this rate is 37% in 2008, 48% in 2013 and 52% in 2018, according to Turkey Demographic and Health Research (TNSA) data. reported as. This situation brings many problems related to the postpartum period.
Cesarean section is a surgical intervention, not a form of delivery, and as with any surgical intervention, there are many risks. Moreover, the most important difference of cesarean section from any surgical intervention is that the fetus/newborn is also exposed to these risks. In addition, discomfort can be seen depending on the surgical procedure and the incision site after the cesarean section. In the study conducted to examine the cesarean section experiences and post-cesarean care needs of post-natal women; It is stated that almost all puerperant women have problems due to cesarean section, and pain is the leading problem, followed by pain, difficulty in movement, breastfeeding problem due to the incision site, gas, numbness and contraction while walking. It is stated that women who have had cesarean section most frequently experience problems related to their self-care in the early postpartum period, such as pain at the surgery site, difficulty in moving, gas formation, feeding and defecation. If these problems that occur in the mother during the postpartum period are not detected in a timely manner and are not intervened effectively, they can become chronic and negatively affect both the quality of life of the mothers and the health of the newborn.
Aloe vera is seen as an environmentally friendly traditional wound healing agent that increases collagen content and improves cross-links. It contains healing and moisturizing properties with its anti-inflammatory, antiviral, antibacterial, antifungal, antimicrobial properties. When the literature is examined, in the study on the use of aloe vera in cesarean wound healing; It is stated that no side effects of aloe vera gel were observed, the wound healing rate was higher in the first 24 hours in the intervention group, and there was no significant difference between the wound healing scores of the two groups at the end of the 8th day. However, it is recommended to conduct studies with longer interventions on the subject.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Aloe veraAloe vera |
| Control group | No intervention | –routine care (dressing with dry gauze) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In the age range of 18-35,
- Primiparous,
- Gestational week 37 and above,
- Transver incision made,
- Women who volunteered to participate in the study
Key exclusion criteria (11 listed)
- Body mass index not in the range of 18.5-24.9,
- Having pregnancy complications (such as preeclampsia and diabetes),
- Having chronic diseases (such as anemia, coagulopathy, cardiovascular diseases and respiratory and kidney diseases),
- Smoking or substance use,
- Those who use drugs that affect wound healing (glucocorticoids, anticoagulants, immunosuppressants, antibiotics and chemotherapy drugs before cesarean section),
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 |
|---|---|---|
| Aloe veraThe leaves of Aloe vera (Aloe barbadensis) will be identified and verified by Selçuk University Faculty of Agriculture. Aloe vera leaves will be washed with antiseptic solution and cut crosswise using gloves and sterile knife. The thick epidermis will be removed from the middle of the leaf. The gel will be obtained from the parenchyma of the thick juicy leaves of aloe vera. | Other | Experimental group |
Primary outcome
Wound healing
Time frame: 12 hours
It will be assessed using the REEDA scale.
2 secondary outcomes
Ache
Time frame: 12 hours
Life quality
Time frame: 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Sustained Cord Circulation at Emergency Cesarean Section
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Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
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Reducing Chronic Pain Following Cesarean Delivery
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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.
Hediye KARAKOC, PhD principal investigator
KTO Karatay University
Questions about this trial
What is this clinical trial studying?
A study testing Aloe vera in people with Cesarean Section, run by KTO Karatay University.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hediye KARAKOC, PhD (+905412291726, hediye.bekmezci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 12 hours). 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 14 Nov 2023.