Cesarean Section ComplicationsPhase 2NCT03497325
Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing
A Phase 2 study testing autologus platelet rich plasma in people with Cesarean Section Complications, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of intramuscular autologus platelet rich plasma on uterine wound healing after primary cesarean section Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- autologus platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 15 Dec 2020
- Phase
- Phase 2
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Term pregnancy (gestational age between 37-41 weeks).
- Women undergoing cesarean section for the first time.
- Normal vaginal ultrasound examination and exclusion of any pelvic abnormality.
- Uncomplicated cesarean section.
- Lower uterine segment cesarean sections while the women not in labor
Who cannot join
- Women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound
- Women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant.
- Women who will use intrauterine device as a contraceptive method Women with uterine abnormality as cervical stenosis or fibroid uterus multiple gestation, placenta abruption, placenta previa, antepartum hemorrhage prolonged ROM, chorioamnionitis,meconium stained liquor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Efficacy of Intramuscular Autologous Platelet-rich Plasma Injection on Uterine Wound Healing After Primary Cesarean Section
The aim of this study is to evaluate the efficacy of intramuscular autologus platelet rich plasma on uterine wound healing after primary cesarean section
Read the detailed description
110 pregnant female undergoing primary prelabor CS will be randomized to two groups group A)autologus PRP will be prepared from participant venous blood collected from the participants' arm into a syringe primed with ACD-A. then it will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites
group B)normal saline 0.9 will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites.
- Conditions
- Cesarean Section Complications
- Being tested
- autologus platelet rich plasma, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologus platelet rich plasmaDrug
55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision
placeboDrug
55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | 55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision Receives: Drug: autologus platelet rich plasma |
| placebo | Placebo comparator | 55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of cesarean scar defect(niche)
any defect in the anterior myometrium related to scar site
Measured: 12 weeks after CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 Feb 2020
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Rasheedy Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497325
- Sponsor's protocol ID
- ASUM hospital
- Status last verified
- Jul 2021
- First submitted
- 6 Apr 2018
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy of Intramuscular Autologous Platelet-rich Plasma Injection on Uterine Wound Healing After Primary Cesarean Section
- ClinicalTrials.gov ID
- NCT03497325
- Acronym / sponsor ID
- ASUM hospital
- Conditions
- Cesarean Section Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 13 Apr 2018 (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 aim of this study is to evaluate the efficacy of intramuscular autologus platelet rich plasma on uterine wound healing after primary cesarean section
Detailed description
110 pregnant female undergoing primary prelabor CS will be randomized to two groups group A)autologus PRP will be prepared from participant venous blood collected from the participants' arm into a syringe primed with ACD-A. then it will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites
group B)normal saline 0.9 will be injected into uterus after closing uterine incision . Injection sites will be selected near the incision at evenly 20 different sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Drug: autologus platelet rich plasma55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision |
| placebo | Placebo comparator | Drug: placebo55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Term pregnancy (gestational age between 37-41 weeks).
- Women undergoing cesarean section for the first time.
- Normal vaginal ultrasound examination and exclusion of any pelvic abnormality.
- Uncomplicated cesarean section.
- Lower uterine segment cesarean sections while the women not in labor
Key exclusion criteria (3 listed)
- Women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound
- Women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant.
- Women who will use intrauterine device as a contraceptive method Women with uterine abnormality as cervical stenosis or fibroid uterus multiple gestation, placenta abruption, placenta previa, antepartum hemorrhage prolonged ROM, chorioamnionitis,meconium stained liquor
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 |
|---|---|---|
| autologus platelet rich plasma55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision | Drug | PRP |
| placebo55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision | Drug | placebo |
Primary outcome
Presence of cesarean scar defect(niche)
Time frame: 12 weeks after CS
any defect in the anterior myometrium related to scar site
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 21 Jul 2021.
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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 2 study testing autologus platelet rich plasma in people with Cesarean Section Complications, run by Ain Shams University 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 3 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 21 Jul 2021. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Presence of cesarean scar defect(niche) (time frame: 12 weeks after CS). 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 21 Jul 2021.