Clinical trial

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

Name

Assem Anour

Description

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

Trial arms

Trial start

2023-03-01

Estimated PCD

2025-03-01

Trial end

2025-03-15

Status

Recruiting

Treatment

Oxytocin

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

Arms:

Group A, Group B

Other names:

Syntoinon

Size

120

Primary endpoint

Wound healing after Oxytocin injecton

from baseline to 6 days after the Cesarean operation

Pain Relief

From base line to 6 hours postoperatively

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2023-10-17

1 organization

1 product

2 indications

Organization

Product

Indication

Indication