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Completed

NCT Number: NCT03497325

Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing

The aim of this study is to evaluate the efficacy of intramuscular autologus platelet rich plasma on uterine wound healing after primary cesarean section

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams university maternity hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologus platelet rich plasma

Drug

55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision

Placebo

Drug

55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision

Primary outcomes

  1. Presence of cesarean scar defect(niche)

    Time frame: 12 weeks after CS

    any defect in the anterior myometrium related to scar site

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

the Efficacy of Intramuscular Autologous Platelet-rich Plasma Injection on Uterine Wound Healing After Primary Cesarean Section

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2018
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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