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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06531356
Enrollment
108
Registered
2024-08-01
Start date
2024-02-16
Completion date
2024-05-20
Last updated
2024-08-01

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

Conditions

Healing Surgical Wounds, High Risk Pregnancy

Keywords

amniotic fluid, cesarean section scar (healing)

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.

Interventions

BIOLOGICALautologous amniotic fluid

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

OTHERNo amniotic fluid injected in skin edges

conventional closure of skin

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of wound healing1,2,6 weeks postoperativeScars will be assessed objectively regarding Color, Thickness, Pliability, Exudate in participants and controls

Countries

Egypt

Outcome results

None listed

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