Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05745935
Other study ID # Assem Anour
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date March 15, 2025

Study information

Verified date October 2023
Source Egymedicalpedia
Contact Assem Anour, Professor
Phone 01118996837
Email dramoussa77@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

caesarean section rate in Egypt has reached about 60% between primgravidae. Wound complications are of the most common morbidities following cesarean section. The prevalence of wound infection and disruption after cesarean has been reported as 3-15%, averagely speaking 6% and 2-42% in various studies. These complications affect mother's quality of life due to stress, anxiety, delay in mother's ability and health recovery


Description:

Nowadays, cesarean is one of the most common surgical interventions and its prevalence has increased in most countries in the recent years. At present, all efforts are focused on the early and effective healing of caesarean skin wound and its associated complications. There is a wide range of topical and systemic treatments for the management of caesarean skin incision. Topical treatments have side effects and hence are not considered as the treatment of choice for such incisions. Oxytocin is a Nonapeptide hormone of a cyclic six amino-acid structure and a tail of three amino acids, responsible for initiation of the milk ejection reflex and stimulating the uterine contractions. However, other important roles of oxytocin include improvement of social life, exerting pain-relieving, anti anti-stress/anti-inflammatory and restorative effects, friendship and making social relationship with individual or group. However, other important roles of oxytocin include improvement of social life, exerting pain-relieving, anti anti-stress/anti-inflammatory and restorative effects, friendship and making social relationship with individual or group. In conclusion, oxytocin is linked to many different, sometimes opposite effects The intact cyclic molecule may act to initiate social interaction and associated psychophysiological effects, whereas linear oxytocin and C-terminal fragments may induce relaxation and anti-stress effects following social interaction. In this way, the principal hormone oxytocin and its fragments may take part in a behavioral sequence, ranging from approach and interaction to calm and relaxation. Linear fragments, with an exposed cysteine-residue, may exert anti-inflammatory and antioxidant effects and thereby contribute to the health-promoting effects of oxytocin.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 15, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: - Primigravidae women, - Age group from 20- 35 years old. - Gestational age 37-41 weeks, and - Elective caesarean section due to obstetrics indication. - The patient signed an Informed Consent Form authorizing their inclusion Exclusion Criteria: - Multiparous women, - Assisted vaginal delivery, - Normal vaginal delivery, - Emergency caesarean section, - Preterm pre labour rupture of membrane, - Primiparous women with age above 35 years old, - Primiparous women with known connective tissue disease and - Women suffering from chronic diseases such as diabetes, hypertension, cardiovascular diseases, psychiatric diseases, cancer - Smoking Women

Study Design


Intervention

Drug:
Oxytocin
This study will include 100 elective cesarean section in parous women who will be randomized into two groups each of 50 patients,

Locations

Country Name City State
Egypt Al Amerya hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound healing after Oxytocin injecton Injection of the Oxytocin hormon in the cesarean wound before closing it during cesarean delivery and close watching for healing process. from baseline to 6 days after the Cesarean operation
Primary Pain Relief The effect of oxytocin on pain relief using pain score scale, numerical pain score scale from 0-10 where 0 is no pain, from 1-3 is mild pain,4-6 moderate pain and from 7-10 is severe pain. From base line to 6 hours postoperatively
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Recruiting NCT03459547 - Soft Peri-implant Tissue Around Different Abutment Materials N/A
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Active, not recruiting NCT03649308 - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting N/A
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Completed NCT03285542 - Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty N/A
Recruiting NCT05689775 - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting NCT05474911 - PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY. N/A
Recruiting NCT04849143 - The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation N/A
Completed NCT03596112 - The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care N/A
Recruiting NCT05169814 - Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds Early Phase 1
Completed NCT04545476 - Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities N/A
Completed NCT06020157 - Comparison of Simple and Continuous Suture Techniques in Oral Surgery N/A
Recruiting NCT05133570 - Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
Recruiting NCT04901325 - Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG) Phase 2
Withdrawn NCT03668665 - Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design" Phase 3
Completed NCT03703479 - Effect of A-PRF After Removal of Wisdom Teeth N/A
Recruiting NCT03204851 - Microlyte Dressing in the Management of Wounds N/A
Recruiting NCT06117436 - Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients Phase 2/Phase 3
Completed NCT05618912 - Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment N/A