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

NCT06531356 | Completed Phase 4

• 1 other identifier: MS-141-2023
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

High Risk Pregnancy; Healing Surgical Wounds

Keywords

amniotic fluid; cesarean section scar (healing)

Outcome Measures

Primary Outcomes (1)

• Quality of wound healing

  Scars will be assessed objectively regarding Color, Thickness, Pliability, Exudate in participants and controls

  1,2,6 weeks postoperative

Study Arms (2)

cases

EXPERIMENTAL

Biological: autologous amniotic fluid

control

ACTIVE COMPARATOR

Other: No amniotic fluid injected in skin edges

Interventions

autologous amniotic fluid BIOLOGICAL

10 cc of amniotic fluid aspirated after opening uterine incision in cesarean section, then Injected in edges of skin before closure

cases

No amniotic fluid injected in skin edges OTHER

conventional closure of skin

control

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

kasr Al Aini, Faculty of Medicine, Cairo University

Cairo, Old Cairo, 11562, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology, Cairo University

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: August 1, 2024
• Study Start: February 16, 2024
• Primary Completion: May 16, 2024
• Study Completion: May 20, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

EG (1)