The Collection and Application of Autologous Amniotic Fluid At Cesarean Delivery Closure.

NCT04359472 | Completed DMC FDA Device

• 1 other identifier: CEALOGIC-DUKE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 wound closure.

Conditions

Pregnancy Related; Cesarean Wound Disruption; Cesarean Section; Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cesarean Wound Complication

  6 weeks

• Assessment of the Cesarean Wound

  4 weeks

• Pain Medication Use

  4 and 6 weeks

• Pain Score

  4 and 6 weeks

Study Arms (1)

Treatment Arm

OTHER

Collection and reapplication of amniotic fluid.

Device: Application of Autologous Amniotic Fluid

Interventions

Application of Autologous Amniotic Fluid DEVICE

Collection and reapplication of amniotic fluid at wound layers during a cesarean section.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant female \> 18 years old, single gestation, plan for cesarean delivery, planned gestational age \> 37 weeks at the time of delivery, english speaking, able to provide own informed consent, intention of being available for entire study period
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Recibio, Inc.: lead
• Duke University: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

Related Publications (10)

• Hamilton BE, Martin JA, Osterman MJ. Births: Preliminary Data for 2015. Natl Vital Stat Rep. 2016 Jun;65(3):1-15.

  PMID: 27309256 BACKGROUND

• 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.

  PMID: 24461076 BACKGROUND

• 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.ajog.2014.01.026.

  PMID: 24565430 BACKGROUND

• 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.

  PMID: 16816051 BACKGROUND

• 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.

  PMID: 6155575 BACKGROUND

• 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.

  PMID: 17346544 BACKGROUND

• 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.

  PMID: 16921691 BACKGROUND

• 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 incidence of arthrofibrosis. Knee Surg Sports Traumatol Arthrosc. 2007 Jul;15(7):888-94. doi: 10.1007/s00167-007-0296-x. Epub 2007 Feb 24.

  PMID: 17323096 BACKGROUND

• 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. doi: 10.1089/ten.TEC.2015.0381. Epub 2016 Mar 18.

  PMID: 26739252 BACKGROUND

• 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.

  PMID: 16524157 BACKGROUND

MeSH Terms

Conditions

Infections

Study Officials

• Jennifer Gilner, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)