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

Kasr El Aini Hospital

Status and phase: Completed; Phase 4

Conditions: Healing Surgical Wounds; High Risk Pregnancy

Treatments: Other: No amniotic fluid injected in skin edges; Biological: autologous amniotic fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT06531356

MS-141-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: Female

Ages: 30 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

108 participants in 2 patient groups

cases

Experimental group

Treatment:

Biological: autologous amniotic fluid

control

Active Comparator group

Treatment:

Other: No amniotic fluid injected in skin edges