Pregnancy RelatedNCT04359472
The Collection and Application of Autologous Amniotic Fluid At Cesarean Delivery Closure.
A study testing Application of Autologous Amniotic Fluid in people with Pregnancy Related and Cesarean Wound Disruption, run by Recibio, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Cesarean Wound Disruption, Cesarean Section; Infection
- What is being tested?
- Application of Autologous Amniotic Fluid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Collection and Application of Autologous Amniotic Fluid At Cesarean Delivery Closure - a Feasibility Study.
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.
Read the 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 at term undergoing cesarean delivery at Duke University Hospital. The objective of the study is to determine the feasibility of collection and application of autologous amniotic fluid at cesarean delivery.
VISIT 1: Screening/Enrollment Visit:
Once informed consent is obtained, demographic information, as well as medical and surgical history will be obtained. A medical release form will also be signed so that in the event that the subject is seen outside the Duke Health system after delivery, the study team will be able to request pertinent medical records.
VISIT 2: Day of Surgery Visit:
At presentation for delivery, study team members will reconfirm eligibility criteria. Subjects will then undergo cesarean delivery as per standard care.
The Recibio kit includes the following supplies, all of which are packaged in a sterile kit and will be opened onto the sterile surgical field:
- Mucous trap
- Yankauer suction device
- Tubing to connect to wall suction
- 10 ml syringe
- 1 ml syringe
- Syringe spray applicator and spray tip with attached syringes - the spray device is included in sterile packaging and manufactured and distributed by Recibio, Inc. Ratio Applicator Kit, Ref # 2101 with an have FDA clearance via Class 1 exempt device FDA listing number D377967. 10% calcium chloride vials will be provided separately. Vials will not be placed on the sterile field as it will likely not have sterile packaging. The calcium chloride solution will either be poured into a small sterile bowl so that it may be drawn up into the1 cc device syringe in a sterile manner OR drawn up into the device syringe directly by a member of the sterile surgical team while a member of the study team holds the non-sterile portion of the vial.
The sterile supplies will be placed on the surgical table and set up for use prior to the start of the cesarean section. The surgery will begin and be completed as part of standard of care.
Once the uterine incision has been made the following steps will be taken:
Following incision of the lower uterine segment, the amniotic sac will be opened with an amniotic perforator.
The Yankauer will be used to suction the amniotic fluid into the mucous trap as it escapes from the amniotic cavity.
After delivery of the newborn and placenta and the uterine incision closed, the amniotic fluid will be drawn from the mucous trap into the 10 ml syringe
The 10 mL syringe containing the amniotic fluid will then be observed for gross contamination (i.e. vernix, meconium-staining) and then attached to the spray device.
The 1 ml syringe containing 1 ml of 10% calcium chloride will then also be attached to the spray device via the second port (final concentration of 1% once sprayed).
The amniotic fluid-calcium chloride mixture will then be sprayed (1.5 to 2.0 ml) across the closed uterine incision and lower uterine segment.
Next the fascia will be closed and the fascial incision sprayed (1.5 to 2.0 ml).
Finally, the subcutaneous tissue will be closed and sprayed (1.5 to 2.0 ml) and then the skin will be closed and sprayed (1.5 to 2.0 ml).
A photo of the closed incision will be taken prior to the application of any bandages.
The incision will then be dressed as part of standard practice.
Any extra amniotic fluid will be kept and stored at -80 degrees in the Duke Reproductive Biology and Perinatal Research Laboratory for potential future research.
Since this study is testing product feasibility, only licensed investigators that are included as study personnel will be permitted to apply CeaLogic to the various tissue layers as described above.
Data elements regarding certain time points during surgery, use of the CeaLogic, and any complications will be recorded. These include, but are not limited to:
Procedure start time (incision time)
Time of uterine incision
Approximate volume of amniotic fluid collected
Description of amniotic fluid (color, presence/absence of vernix, blood, or meconium-staining)
Time that uterine closure is complete
Approximate spray volume to closed uterine incision
Approximate spray volume to closed abdominal fascia
Approximate spray volume to closed subcutaneous tissue
Approximate spray volume to closed skin
Procedure end time
Estimated blood loss
Type of skin closure
VISIT 3: Day of Discharge Visit:
The subject will receive routine post-operative care during the immediate post-operative period. Most cesarean section patients are discharged home on post-operative day 2 or 3. The following study activities will occur at this visit:
A photo of the incision site
Assessment of the incision site that includes presence of redness, swelling, induration, as well as pain at rest and with gentle pressure
The amount of pain medication used since delivery (non-steroidal anti-inflammatory agents and narcotics)
The patient will be provided with a memory aid to record pain level and any pain medications that she takes once she goes home.
An instruction form on how to complete the memory aid, as well as study team contact information, should the patient have questions or problems related to her incision.
Scheduling of the first follow up visit that will occur 6-8 days after surgery.
The study team will monitor the subject's medical record for vital signs and record any evidence of post-operative fever (maternal temperature greater than 38 degrees C its source, and action taken by the care team.
Documentation of any adverse events
VISIT 4: 1 Week Follow Up Visit:
Subjects will be seen at the Duke Perinatal Research Center approximately one week following her procedure (post-operative day 6-8).
At this visit the following study procedures will occur:
Photo of the wound
Assessment of the incision
Documentation of any signs or symptoms of infection
Review of the subject's memory aid for pain and pain medication
Documentation of any adverse events
Scheduling of the next study visit (approximately 4 weeks post-delivery)
VISIT 5: 4 Week Follow Up Visit:
Subjects will be seen during the routine postpartum clinic visit at approximately 4 weeks following delivery.
At this visit the following study procedures will occur:
Photo of the wound
Assessment of the incision
Documentation of any signs or symptoms of infection
Documentation of any adverse events
Review of the subject's memory aid for pain and pain medication
VISIT 6: Phone Call Follow Up Visit:
The subject will be contacted by telephone by a member of the study team approximately 6 weeks after delivery to determine if she had any wound complications since her last visit. If so, the subject's medical record will be reviewed to determine if there were any complications or treatment pertaining to her cesarean section incision. If the subject received this care outside of the Duke Health system, the signed medical records release will be sent to the applicable health care facility to request pertinent to be reviewed. An IRB-approved phone script will be used for this phone call. The subject will also be asked a series of questions pertaining to medication use, pain at the incision site, and activity level. Adverse events will be documented if they have occurred.
Unscheduled Study Visit:
If a study subject contacts the study team with concern for complications with her cesarean section wound, an unscheduled visit will be completed. This visit can happen anytime during the subject's participation(up to 30 days following the procedure where the procedure day is day 1), but after the CeaLogic has been applied.
During this visit, study staff will perform the following study procedures:
Photo of the wound
Assessment of the incision
Documentation of any signs or symptoms of infection
Documentation of adverse events
Review of medical record for any treatment actions taken related to the cesarean section wound
Product Use questionnaire:
In addition to the above study activities, each time a licensed investigator uses CeaLogic, they will be asked to complete a short questionnaire about their experience with using the device. No personal identifying information will be captured in this questionnaire. Information gathered from these questionnaires will be compiled and given to the sponsor for feedback and possible product improvements.
- Being tested
- Application of Autologous Amniotic Fluid
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Autologous Amniotic FluidDevice
Collection and reapplication of amniotic fluid at wound layers during a cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | Collection and reapplication of amniotic fluid. Receives: Device: Application of Autologous Amniotic Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection and reapplication of autologous amniotic fluid
Feasibility of collection and reapplication of autologous amniotic fluid at the time of a cesarean delivery
Measured: At time of delivery
Secondary outcomes (4)
Cesarean Wound Complication
Cesarean wound disruption, infection, hematoma, seroma
Measured: 6 weeks
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.
Measured: 4 weeks
Pain Medication Use
Measure the patient's pain medication use
Measured: 4 and 6 weeks
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.
Measured: 4 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Oct 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recibio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Jennifer Gilner, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359472
- Sponsor's protocol ID
- CEALOGIC-DUKE
- Status last verified
- Dec 2024
- First submitted
- 21 Apr 2020
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hamilton BE, Martin JA, Osterman MJ. Births: Preliminary Data for 2015. Natl Vital Stat Rep. 2016 Jun;65(3):1-15.
PubMed 27309256Osterman 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.
PubMed 24461076American 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.
PubMed 24565430Nisenblat 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.
PubMed 16816051Faulk 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.
PubMed 6155575Stock 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.
PubMed 17346544Brady 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.
PubMed 16921691Everts 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.
PubMed 17323096Thiebes 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.
PubMed 26739252Trowbridge 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.
PubMed 16524157
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Collection and Application of Autologous Amniotic Fluid At Cesarean Delivery Closure - a Feasibility Study.
- ClinicalTrials.gov ID
- NCT04359472
- Acronym / sponsor ID
- CEALOGIC-DUKE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Recibio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 at term undergoing cesarean delivery at Duke University Hospital. The objective of the study is to determine the feasibility of collection and application of autologous amniotic fluid at cesarean delivery.
VISIT 1: Screening/Enrollment Visit:
Once informed consent is obtained, demographic information, as well as medical and surgical history will be obtained. A medical release form will also be signed so that in the event that the subject is seen outside the Duke Health system after delivery, the study team will be able to request pertinent medical records.
VISIT 2: Day of Surgery Visit:
At presentation for delivery, study team members will reconfirm eligibility criteria. Subjects will then undergo cesarean delivery as per standard care.
The Recibio kit includes the following supplies, all of which are packaged in a sterile kit and will be opened onto the sterile surgical field:
- Mucous trap
- Yankauer suction device
- Tubing to connect to wall suction
- 10 ml syringe
- 1 ml syringe
- Syringe spray applicator and spray tip with attached syringes - the spray device is included in sterile packaging and manufactured and distributed by Recibio, Inc. Ratio Applicator Kit, Ref # 2101 with an have FDA clearance via Class 1 exempt device FDA listing number D377967. 10% calcium chloride vials will be provided separately. Vials will not be placed on the sterile field as it will likely not have sterile packaging. The calcium chloride solution will either be poured into a small sterile bowl so that it may be drawn up into the1 cc device syringe in a sterile manner OR drawn up into the device syringe directly by a member of the sterile surgical team while a member of the study team holds the non-sterile portion of the vial.
The sterile supplies will be placed on the surgical table and set up for use prior to the start of the cesarean section. The surgery will begin and be completed as part of standard of care.
Once the uterine incision has been made the following steps will be taken:
Following incision of the lower uterine segment, the amniotic sac will be opened with an amniotic perforator.
The Yankauer will be used to suction the amniotic fluid into the mucous trap as it escapes from the amniotic cavity.
After delivery of the newborn and placenta and the uterine incision closed, the amniotic fluid will be drawn from the mucous trap into the 10 ml syringe
The 10 mL syringe containing the amniotic fluid will then be observed for gross contamination (i.e. vernix, meconium-staining) and then attached to the spray device.
The 1 ml syringe containing 1 ml of 10% calcium chloride will then also be attached to the spray device via the second port (final concentration of 1% once sprayed).
The amniotic fluid-calcium chloride mixture will then be sprayed (1.5 to 2.0 ml) across the closed uterine incision and lower uterine segment.
Next the fascia will be closed and the fascial incision sprayed (1.5 to 2.0 ml).
Finally, the subcutaneous tissue will be closed and sprayed (1.5 to 2.0 ml) and then the skin will be closed and sprayed (1.5 to 2.0 ml).
A photo of the closed incision will be taken prior to the application of any bandages.
The incision will then be dressed as part of standard practice.
Any extra amniotic fluid will be kept and stored at -80 degrees in the Duke Reproductive Biology and Perinatal Research Laboratory for potential future research.
Since this study is testing product feasibility, only licensed investigators that are included as study personnel will be permitted to apply CeaLogic to the various tissue layers as described above.
Data elements regarding certain time points during surgery, use of the CeaLogic, and any complications will be recorded. These include, but are not limited to:
Procedure start time (incision time)
Time of uterine incision
Approximate volume of amniotic fluid collected
Description of amniotic fluid (color, presence/absence of vernix, blood, or meconium-staining)
Time that uterine closure is complete
Approximate spray volume to closed uterine incision
Approximate spray volume to closed abdominal fascia
Approximate spray volume to closed subcutaneous tissue
Approximate spray volume to closed skin
Procedure end time
Estimated blood loss
Type of skin closure
VISIT 3: Day of Discharge Visit:
The subject will receive routine post-operative care during the immediate post-operative period. Most cesarean section patients are discharged home on post-operative day 2 or 3. The following study activities will occur at this visit:
A photo of the incision site
Assessment of the incision site that includes presence of redness, swelling, induration, as well as pain at rest and with gentle pressure
The amount of pain medication used since delivery (non-steroidal anti-inflammatory agents and narcotics)
The patient will be provided with a memory aid to record pain level and any pain medications that she takes once she goes home.
An instruction form on how to complete the memory aid, as well as study team contact information, should the patient have questions or problems related to her incision.
Scheduling of the first follow up visit that will occur 6-8 days after surgery.
The study team will monitor the subject's medical record for vital signs and record any evidence of post-operative fever (maternal temperature greater than 38 degrees C its source, and action taken by the care team.
Documentation of any adverse events
VISIT 4: 1 Week Follow Up Visit:
Subjects will be seen at the Duke Perinatal Research Center approximately one week following her procedure (post-operative day 6-8).
At this visit the following study procedures will occur:
Photo of the wound
Assessment of the incision
Documentation of any signs or symptoms of infection
Review of the subject's memory aid for pain and pain medication
Documentation of any adverse events
Scheduling of the next study visit (approximately 4 weeks post-delivery)
VISIT 5: 4 Week Follow Up Visit:
Subjects will be seen during the routine postpartum clinic visit at approximately 4 weeks following delivery.
At this visit the following study procedures will occur:
Photo of the wound
Assessment of the incision
Documentation of any signs or symptoms of infection
Documentation of any adverse events
Review of the subject's memory aid for pain and pain medication
VISIT 6: Phone Call Follow Up Visit:
The subject will be contacted by telephone by a member of the study team approximately 6 weeks after delivery to determine if she had any wound complications since her last visit. If so, the subject's medical record will be reviewed to determine if there were any complications or treatment pertaining to her cesarean section incision. If the subject received this care outside of the Duke Health system, the signed medical records release will be sent to the applicable health care facility to request pertinent to be reviewed. An IRB-approved phone script will be used for this phone call. The subject will also be asked a series of questions pertaining to medication use, pain at the incision site, and activity level. Adverse events will be documented if they have occurred.
Unscheduled Study Visit:
If a study subject contacts the study team with concern for complications with her cesarean section wound, an unscheduled visit will be completed. This visit can happen anytime during the subject's participation(up to 30 days following the procedure where the procedure day is day 1), but after the CeaLogic has been applied.
During this visit, study staff will perform the following study procedures:
Photo of the wound
Assessment of the incision
Documentation of any signs or symptoms of infection
Documentation of adverse events
Review of medical record for any treatment actions taken related to the cesarean section wound
Product Use questionnaire:
In addition to the above study activities, each time a licensed investigator uses CeaLogic, they will be asked to complete a short questionnaire about their experience with using the device. No personal identifying information will be captured in this questionnaire. Information gathered from these questionnaires will be compiled and given to the sponsor for feedback and possible product improvements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Device: Application of Autologous Amniotic FluidCollection and reapplication of amniotic fluid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Autologous Amniotic FluidCollection and reapplication of amniotic fluid at wound layers during a cesarean section. | Device | Treatment Arm |
Primary outcome
Collection and reapplication of autologous amniotic fluid
Time frame: At time of delivery
Feasibility of collection and reapplication of autologous amniotic fluid at the time of a cesarean delivery
4 secondary outcomes
Cesarean Wound Complication
Time frame: 6 weeks
Assessment of the Cesarean Wound
Time frame: 4 weeks
Pain Medication Use
Time frame: 4 and 6 weeks
Pain Score
Time frame: 4 and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Background: PubMed 27309256Hamilton BE, Martin JA, Osterman MJ. Births: Preliminary Data for 2015. Natl Vital Stat Rep. 2016 Jun;65(3):1-15.
- Background: PubMed 24461076Osterman 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.
- Background: PubMed 24565430American 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.
- Background: PubMed 16816051Nisenblat 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.
- Background: PubMed 6155575Faulk 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.
- Background: PubMed 17346544Stock 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.
- Background: PubMed 16921691Brady 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.
- Background: PubMed 17323096Everts 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.
- Background: PubMed 26739252Thiebes 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.
- Background: PubMed 16524157Trowbridge 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.
- Individual participant dataSharing planned: No
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Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Gilner, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Autologous Amniotic Fluid in people with Pregnancy Related and Cesarean Wound Disruption, run by Recibio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection and reapplication of autologous amniotic fluid (time frame: At time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359472, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.