Effect of Autologous Platelet-rich Plasma in Uterine Woun... | NCT03497325

Studies
Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

NCT03497325

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jul 21, 2021Actual

Enrollment

134Actual

Phase

Phase 2

Conditions

Cesarean Section Complications

Interventions

autologus platelet rich plasma
placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

Dec 15, 2020Actual

Completion Date

Dec 15, 2020Actual

First Submitted Date

Apr 6, 2018

First Submission Date that Met QC Criteria

Apr 11, 2018

First Posted Date

Apr 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2021

Last Update Posted Date

Jul 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRP	Experimental	55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision	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	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
autologus platelet rich plasma	Drug	55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision	PRP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of cesarean scar defect(niche)	any defect in the anterior myometrium related to scar site	12 weeks after CS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided