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

NCT ID: NCT06531356

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-16

Study Completion Date

2024-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

High Risk Pregnancy Healing Surgical Wounds

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cases

Group Type EXPERIMENTAL

autologous amniotic fluid

Intervention Type BIOLOGICAL

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

control

Group Type ACTIVE_COMPARATOR

No amniotic fluid injected in skin edges

Intervention Type OTHER

conventional closure of skin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

autologous amniotic fluid

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

Intervention Type BIOLOGICAL

No amniotic fluid injected in skin edges

conventional closure of skin

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hend Mahmoud Abdelghany

Lecturer of Obstetrics and Gynecology, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

kasr Al Aini, Faculty of Medicine, Cairo University

Cairo, Old Cairo, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MS-141-2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.