Status:
COMPLETED
The Collection and Application of Autologous Amniotic Fluid At Cesarean Delivery Closure.
Lead Sponsor:
Recibio, Inc.
Collaborating Sponsors:
Duke University
Conditions:
Pregnancy Related
Cesarean Wound Disruption
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine the feasibility of collecting amniotic fluid at delivery that will be immediately processed and then applied as a spray to the various layers of cesarean woun...
Detailed Description
This is a single-site, prospective pilot study involving the collection of amniotic fluid at cesarean delivery followed by the immediate processing and re-application to the closure among twenty women...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Pregnant female age great than 18 years
- Singleton gestation
- Plan for cesarean delivery
- Planned gestational age of at least weeks at the time of delivery
- English speaking
- Able to provide own informed consent
- Intention of being available for entire study period and complete all relevant study procedures, including follow-up study visits and phone calls
- Exclusion criteria at screening/enrollment:
- Diabetes requiring therapy (type I or type II diabetes, gestational diabetes on medical therapy)
- BMI greater than or equal to 40 kg/m2 at the time of enrollment
- Placenta previa or placenta accreta
- Prior bowel or urologic surgery (except un-ruptured appendectomy or uncomplicated cholecystectomy)
- Multiple gestation
- Previous history of postpartum hemorrhage requiring medical or surgical treatment
- Known or suspected impairment of immunologic function including infection with HIV, hepatitis B or C
- Known tobacco or drug use
- Any condition which, in the opinion of the investigator, may pose a health risk to the subject or interfere with the evaluation of the study objectives
- History of keloid formation
- Exclusion criteria at time of surgery:
- Labor at time of presentation to labor and delivery (regular, painful uterine contractions occurring every 5 minutes with evidence of cervical change)
- Chorioamnionitis or other systemic infection at time of presentation for cesarean section, including evidence of lower abdominal skin infection (i.e. yeast, etc)
- Need for urgent Cesarean section (examples include, but not limited to: non-reassuring fetal status (category II or III tracing), placental abruption, severe preeclampsia or eclampsia)
- Rupture of membranes prior to the start of the surgery
- Meconium-stained or blood-stained amniotic fluid
- Experiences intraoperative hemorrhage requiring transfusion, disseminated-intravascular coagulopathy (DIC), or other medical or surgical condition during the delivery deemed by the investigator to pose a prohibitively high risk for surgical re-exploration or wound complication.
- Who, in the investigator's opinion, would have any clinically significant condition that would impair the patient's ability to comply with the study procedures
- Need for vertical skin incision
- Intraoperative use of hemostatic agent (examples include FLOSEAL and AVIGUARD®)
- Plan for use of staples at closure of the skin incision
- Preeclampsia with severe features
Exclusion
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04359472
Start Date
October 1 2020
End Date
September 1 2024
Last Update
December 13 2024
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27708