Pregnancy Related Clinical Trial
Official title:
The Collection and Application of Autologous Amniotic Fluid at Cesarean Delivery Closure - a Feasibility Study.
Verified date | April 2024 |
Source | Recibio, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 wound closure.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | July 2024 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Pregnant female age great than 18 years 2. Singleton gestation 3. Plan for cesarean delivery 4. Planned gestational age of at least weeks at the time of delivery 5. English speaking 6. Able to provide own informed consent 7. 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: 1. Diabetes requiring therapy (type I or type II diabetes, gestational diabetes on medical therapy) 2. BMI greater than or equal to 40 kg/m2 at the time of enrollment 3. Placenta previa or placenta accreta 4. Prior bowel or urologic surgery (except un-ruptured appendectomy or uncomplicated cholecystectomy) 5. Multiple gestation 6. Previous history of postpartum hemorrhage requiring medical or surgical treatment 7. Known or suspected impairment of immunologic function including infection with HIV, hepatitis B or C 8. Known tobacco or drug use 9. 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 10. History of keloid formation Exclusion criteria at time of surgery: 1. Labor at time of presentation to labor and delivery (regular, painful uterine contractions occurring every 5 minutes with evidence of cervical change) 2. Chorioamnionitis or other systemic infection at time of presentation for cesarean section, including evidence of lower abdominal skin infection (i.e. yeast, etc) 3. 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) 4. Rupture of membranes prior to the start of the surgery 5. Meconium-stained or blood-stained amniotic fluid 6. 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. 7. 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 8. Need for vertical skin incision 9. Intraoperative use of hemostatic agent (examples include FLOSEAL and AVIGUARDĀ®) 10. Plan for use of staples at closure of the skin incision 11. Preeclampsia with severe features |
Country | Name | City | State |
---|---|---|---|
United States | Duke University | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Recibio, Inc. | Duke University |
United States,
American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine; Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.aj — View Citation
Brady C, Vang S, Christensen K, Isler J, Vollstedt K, Holt D. Use of autologous platelet gel in bariatric surgery. J Extra Corpor Technol. 2006 Jun;38(2):161-4. — View Citation
Everts PA, Devilee RJ, Oosterbos CJ, Mahoney CB, Schattenkerk ME, Knape JT, van Zundert A. Autologous platelet gel and fibrin sealant enhance the efficacy of total knee arthroplasty: improved range of motion, decreased length of stay and a reduced inciden — View Citation
Faulk WP, Matthews R, Stevens PJ, Bennett JP, Burgos H, Hsi BL. Human amnion as an adjunct in wound healing. Lancet. 1980 May 31;1(8179):1156-8. doi: 10.1016/s0140-6736(80)91617-7. — View Citation
Hamilton BE, Martin JA, Osterman MJ. Births: Preliminary Data for 2015. Natl Vital Stat Rep. 2016 Jun;65(3):1-15. — View Citation
Nisenblat V, Barak S, Griness OB, Degani S, Ohel G, Gonen R. Maternal complications associated with multiple cesarean deliveries. Obstet Gynecol. 2006 Jul;108(1):21-6. doi: 10.1097/01.AOG.0000222380.11069.11. — View Citation
Osterman MJ, Martin JA. Primary cesarean delivery rates, by state: results from the revised birth certificate, 2006-2012. Natl Vital Stat Rep. 2014 Jan;63(1):1-11. — View Citation
Stock SJ, Kelly RW, Riley SC, Calder AA. Natural antimicrobial production by the amnion. Am J Obstet Gynecol. 2007 Mar;196(3):255.e1-6. doi: 10.1016/j.ajog.2006.10.908. — View Citation
Thiebes AL, Reddemann MA, Palmer J, Kneer R, Jockenhoevel S, Cornelissen CG. Flexible Endoscopic Spray Application of Respiratory Epithelial Cells as Platform Technology to Apply Cells in Tubular Organs. Tissue Eng Part C Methods. 2016 Apr;22(4):322-31. d — View Citation
Trowbridge CC, Stammers AH, Woods E, Yen BR, Klayman M, Gilbert C. Use of platelet gel and its effects on infection in cardiac surgery. J Extra Corpor Technol. 2005 Dec;37(4):381-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Collection and reapplication of autologous amniotic fluid | Feasibility of collection and reapplication of autologous amniotic fluid at the time of a cesarean delivery | At time of delivery | |
Secondary | Cesarean Wound Complication | Cesarean wound disruption, infection, hematoma, seroma | 6 weeks | |
Secondary | Assessment of the Cesarean Wound | Assessment of would via validated cosmetic score using the Modified Hollander Score. This involves 6 incision attributes (e.g. step off boarders, contour irregularities, etc.) that are listed and a score of a 0 or 1 are given. A 0 means "No" the attribute does not exist which is good and a score of 1 means "Yes" the attribute does exist. After scoring all 6 attributes a 0 or a 1, the numbers are totaled with a being the best and 6 being the worst. | 4 weeks | |
Secondary | Pain Medication Use | Measure the patient's pain medication use | 4 and 6 weeks | |
Secondary | Pain Score | Measure the patient's pain using the visual analog scale (VAS). It is a scale from 1-10 where 1 is the lowest and 10 is the highest. | 4 and 6 weeks |
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