Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing
the Efficacy of Intramuscular Autologous Platelet-rich Plasma Injection on Uterine Wound Healing After Primary Cesarean Section
1 other identifier
interventional
134
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedJuly 21, 2021
July 1, 2021
11 months
April 6, 2018
July 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of cesarean scar defect(niche)
any defect in the anterior myometrium related to scar site
12 weeks after CS
Study Arms (2)
PRP
EXPERIMENTAL55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision
placebo
PLACEBO COMPARATOR55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision
Interventions
55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision
55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision
Eligibility Criteria
You may qualify if:
- Term pregnancy (gestational age between 37-41 weeks).
- Women undergoing cesarean section for the first time.
- Uncomplicated cesarean section.
- Lower uterine segment cesarean sections while the women not in labor
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams university maternity hospital
Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
April 6, 2018
First Posted
April 13, 2018
Study Start
February 1, 2020
Primary Completion
December 15, 2020
Study Completion
December 15, 2020
Last Updated
July 21, 2021
Record last verified: 2021-07