NCT05745935

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 12, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

February 12, 2023

Last Update Submit

October 14, 2023

Conditions

Wound HealScar; Previous Cesarean Section

Keywords

wound healingOxytocincaesarean Section scarwound complications

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Group A

EXPERIMENTAL

About 50 Patients Will receive 20 units of local oxytocin infiltration before skin closure . 10 units of oxytocin will be infiltrated at the upper skin edge and 10 units of oxytocin will be infilterated at the lower skin edges at equal intervals of 2 cm in between infiltration points.

Drug: Oxytocin

Group B

EXPERIMENTAL

About 50 Patients Will receive the 10 units of local oxytocin infiltration before skin closure . 5 units will be infiltrated at the upper skin edge and 5 units will be infiltrated at the lower skin edge at equal intervals of approximately 2 cm in between infiltration points.

Drug: Oxytocin

Interventions

OxytocinDRUG

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

Also known as: Syntoinon
Group AGroup B

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primigravidae women,
  • Age group from 20- 35 years old.
  • Gestational age 37-41 weeks, and
  • Elective caesarean section due to obstetrics indication.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Amerya hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cicatrix

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Assem Anour, Professor

    Al-Azhar University, Faculty of medicine for boys

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Assem Anour, Professor

CONTACT

01118996837dramoussa77@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 27, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 15, 2025

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

EG(1)