Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population

Phase 4

Completed

• Conditions: Healing Surgical Wounds; High Risk Pregnancy
• Interventions: Biological: autologous amniotic fluid; Other: No amniotic fluid injected in skin edges

• Registration Number: NCT06531356
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

The goal of this randomized controlled trial is to investigate the effect of injection of autologous amniotic fluid in the healing of the scar of cesarean section among high-risk population. Investigator's aim is to know : quality of wound healing, rate of infection and time needed for complete healing. Participants will be divided into two groups. All participants will undergo cesarean section. We will inject autologous amniotic fluid in the edges of the wound during skin closure in half of the participants. Wound healing will be assessed at 1st, 2nd and 6th week postoperatively.

Detailed Description

After surgery, participants will be observed along 6 weeks (at 1, 2 and 6 weeks intervals) and scars will be assessed regarding color, thickness, pliability and presence of exudate.

Study Timeline

• Study First Submitted: 2024-02-13
• Study Start: 2024-02-16
• Primary Completion: 2024-05-16
• Study Completion: 2024-05-20
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

• Age > 30 years old.
• Anemic patients
• Maternal chronic disease e.g., Diabetes and Hypertension
• BMI of > 25 Kg/m2.
• Underwent previous CS.

Exclusion Criteria

• Rupture of membrane.
• No previous section.
• Anhydraminos.
• Congenital malformation of the fetus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cases	autologous amniotic fluid	-
control	No amniotic fluid injected in skin edges	-

Primary Outcome Measures

Name	Time	Method
Quality of wound healing	1,2,6 weeks postoperative	Scars will be assessed objectively regarding Color, Thickness, Pliability, Exudate in participants and controls

Trial Locations

Locations (1)

kasr Al Aini, Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Old Cairo, Egypt