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Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing

Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing of Caesarean Section Scar in Primiparous Women A Double Blind Randomized Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05745935
Enrollment
120
Registered
2023-02-27
Start date
2023-03-01
Completion date
2025-03-15
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar; Previous Cesarean Section, Wound Heal

Keywords

wound healing, Oxytocin, caesarean Section scar, wound complications

Brief 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

Detailed 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.

Interventions

DRUGOxytocin

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

Sponsors

Egymedicalpedia
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Wound healing after Oxytocin injectonfrom baseline to 6 days after the Cesarean operationInjection of the Oxytocin hormon in the cesarean wound before closing it during cesarean delivery and close watching for healing process.
Pain ReliefFrom base line to 6 hours postoperativelyThe 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.

Countries

Egypt

Contacts

Primary ContactAssem Anour, Professor
dramoussa77@hotmail.com01118996837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026