High Risk PregnancyPhase 4NCT06531356
Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population
A Phase 4 study testing autologous amniotic fluid and No amniotic fluid injected in skin edges in people with High Risk Pregnancy and Healing Surgical Wounds, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- High Risk Pregnancy, Healing Surgical Wounds
- What is being tested?
- autologous amniotic fluid and No amniotic fluid injected in skin edges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Feb 2024to 20 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age > 30 years old.
- Anemic patients
- Maternal chronic disease e.g., Diabetes and Hypertension
- BMI of > 25 Kg/m2.
- Underwent previous CS.
Who cannot join
- Rupture of membrane.
- No previous section.
- Anhydraminos.
- Congenital malformation of the fetus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
kasr Al Aini, Faculty of Medicine, Cairo University
Cairo, Old Cairo, 11562
About this study
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.
Read the 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.
- Conditions
- High Risk Pregnancy, Healing Surgical Wounds
- Being tested
- autologous amniotic fluid, No amniotic fluid injected in skin edges
- Keywords
- amniotic fluid, cesarean section scar (healing)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous amniotic fluidBiological
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 edgesOther
conventional closure of skin
| Study group | Role | What they receive |
|---|---|---|
| cases | Experimental | Not described Receives: Biological: autologous amniotic fluid |
| control | Active comparator | Not described Receives: Other: No amniotic fluid injected in skin edges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of wound healing
Scars will be assessed objectively regarding Color, Thickness, Pliability, Exudate in participants and controls
Measured: 1,2,6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start16 Feb 2024
- Primary completion16 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mahmoud Abdelghany, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531356
- Sponsor's protocol ID
- MS-141-2023
- Status last verified
- Jul 2024
- First submitted
- 13 Feb 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Autologous Amniotic Fluid Injection in the Healing of Cesarean Section Scar in High-Risk Population
- ClinicalTrials.gov ID
- NCT06531356
- Acronym / sponsor ID
- MS-141-2023
- Conditions
- High Risk Pregnancy, Healing Surgical Wounds
- Keywords
- amniotic fluid, cesarean section scar (healing)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | Experimental | Biological: autologous amniotic fluid |
| control | Active comparator | Other: No amniotic fluid injected in skin edges |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age > 30 years old.
- Anemic patients
- Maternal chronic disease e.g., Diabetes and Hypertension
- BMI of > 25 Kg/m2.
- Underwent previous CS.
Key exclusion criteria (4 listed)
- Rupture of membrane.
- No previous section.
- Anhydraminos.
- Congenital malformation of the fetus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous amniotic fluid10 cc of amniotic fluid aspirated after opening uterine incision in cesarean section, then Injected in edges of skin before closure | Biological | cases |
| No amniotic fluid injected in skin edgesconventional closure of skin | Other | control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing autologous amniotic fluid and No amniotic fluid injected in skin edges in people with High Risk Pregnancy and Healing Surgical Wounds, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of wound healing (time frame: 1,2,6 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.