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

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.

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Key information

Conditions

High Risk Pregnancy Healing Surgical Wounds

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

kasr Al Aini, Faculty of Medicine, Cairo University

Cairo, Old Cairo, 11562, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

No amniotic fluid injected in skin edges

Other

conventional closure of skin

Primary outcomes

Quality of wound healing

Time frame: 1,2,6 weeks postoperative

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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Aug 1, 2024
Registry last updated: Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed