Cesarean SectionPhase 2ERACNCT02956616
Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
A Phase 2 study testing ketorolac, Chewing Gum and Enhanced Recovery Protocol in people with Cesarean Section, run by Montefiore Medical Center at 1 site in United States.
Trial summary
To determine whether women randomized to an enhanced recovery program will have improved postoperative outcomes including improved breastfeeding initiation and continuation, reduction in hospital length of stay without compromising patient satisfaction in comparison to standard postoperative recovery interventions. 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
- Cesarean Section
- What is being tested?
- ketorolac, Chewing Gum and Enhanced Recovery Protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 15 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1. Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation
Who cannot join
- Women undergoing an urgent or emergent cesarean birth
- Women less than 18 years old
- Patients receiving general anesthesia
- Abnormally adherent placenta (Placenta Accreta) or expected excessive blood loss (Placenta accreta)
- Pre-existing essential hypertension or hypertensive disorders of pregnancy (preeclampsia, eclampsia, HELLP)
- Chronic or acute renal impairment
Show all 12Show fewer
- Bleeding disorders or platelet dysfunction
- Peptic ulcer disease or gastrointestinal bleeding
- Known hypersensitivity to ketorolac (toradol)
- Active infection at the time of cesarean
- Cesarean birth prior to 37 weeks
- Women in significant pain in labor
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
To determine whether women randomized to an enhanced recovery program will have improved postoperative outcomes including improved breastfeeding initiation and continuation, reduction in hospital length of stay without compromising patient satisfaction in comparison to standard postoperative recovery interventions.
Read the detailed description
The investigators hypothesize that an enhanced recovery program which includes several evidence based interventions at the time of cesarean birth in obstetrics will promote early ambulation, resumption of diet and initiation of breastfeeding, and reduce postoperative hospital length of stay.
Enhanced Recovery Protocol Components:
- Provide preoperative education about the perioperative recovery experience including postoperative analgesia, thromboprophylaxis and breastfeeding education
- Minimize preoperative starvation times
- Moderate amount of clears up to 2 hours prior to anesthesia
- Solid foods up to 6-8 hours prior to anesthesia
- Prophylactic antibiotics
- Venous thromboembolism prophylaxis (mechanical) initiated at the time of cesarean birth and continued postoperatively
- Chewing gum (Xylitol) to reduce postoperative ileus
- Routine administration of Non-steroidal anti-inflammatory drug, Ketorolac, 15mg every hour for 24 hours postoperatively to minimize postoperative narcotic use
- Early initiation of feeding after cesarean, immediately for clears, 30 minutes for regular diet as tolerated
- Early removal of urinary catheter (12 hours postoperatively)
- Early removal of dressing (6 hours postoperatively)
- Early mobilization at 12 hours after delivery
- Early skin-to- skin/breastfeeding initiation
- Early incentive spirometry
Currently, patients are encouraged to ambulate on the first post-operative day, but it is largely left up to the patient when to actually begin to ambulate. They are similarly offered a diet on the first postoperative day but are not encouraged to eat. Breastfeeding is more systematically encouraged early as part of Montefiore's effort to get baby friendly designation. And finally, patients are typically discharged on postoperative day number three unless complications arise in the newborn or the mother. As part of this study, patients in both the enhanced recovery and usual care group will be offered the opportunity to be discharged from the hospital on postoperative day number 2 if their recovery is progressing well and if they choose not to leave then they will be encouraged to return home on postoperative day number 3 according to the current standard of care.
- Conditions
- Cesarean Section
- Being tested
- ketorolac, Chewing Gum, Enhanced Recovery Protocol
- Keywords
- Enhanced Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketorolacDrug
Also called Toradol
Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.
Chewing GumOther
Also called Xylitol
Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for a duration of 30 minutes at each time, based on a metanalysis and systematic review. Patient's will be encouraged on its use for return of bowel function.
Enhanced Recovery ProtocolProcedure or surgery
enhanced recovery protocol (detailed previously) will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing and standing ketorolac for 24 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery | Experimental | Postoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function. Receives: Drug: ketorolac; Other: Chewing Gum; Procedure: Enhanced Recovery Protocol |
| Routine Perioperative Care | Active comparator | Postoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control Receives: Drug: ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge on Postoperative Day #2
Number of patients discharged on postoperative Day #2
Measured: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Secondary outcomes (3)
Postoperative Pain Medication Requirement
The amount of postoperative pain medication required for each patient in Morphine Milligram Equivalents
Measured: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Breastfeeding Initiation
All patients will be queried regarding whether breastfeeding was initiated after cesarean birth and how soon after birth
Measured: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Postoperative Length of Hospital Stay
Postoperative Length of Hospital Stay in Hours from time of surgery
Measured: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start1 Sep 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter S. Bernstein, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956616
- Sponsor's protocol ID
- 2016-6966
- Acronym
- ERAC
- Status last verified
- Apr 2019
- First submitted
- 2 Nov 2016
- Last updated
- 25 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wrench IJ, Allison A, Galimberti A, Radley S, Wilson MJ. Introduction of enhanced recovery for elective caesarean section enabling next day discharge: a tertiary centre experience. Int J Obstet Anesth. 2015 May;24(2):124-30. doi: 10.1016/j.ijoa.2015.01.003. Epub 2015 Jan 14.
PubMed 25794417Brooten D, Roncoli M, Finkler S, Arnold L, Cohen A, Mennuti M. A randomized trial of early hospital discharge and home follow-up of women having cesarean birth. Obstet Gynecol. 1994 Nov;84(5):832-8.
PubMed 7936522Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
PubMed 26580836Habib AS, George RB, McKeen DM, White WD, Ituk US, Megalla SA, Allen TK. Antiemetics added to phenylephrine infusion during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):615-623. doi: 10.1097/AOG.0b013e3182839fee.
PubMed 23635626Masood SN, Masood Y, Naim U, Masood MF. A randomized comparative trial of early initiation of oral maternal feeding versus conventional oral feeding after cesarean delivery. Int J Gynaecol Obstet. 2014 Aug;126(2):115-9. doi: 10.1016/j.ijgo.2014.02.023. Epub 2014 Apr 29.
PubMed 24856433Huang H, Wang H, He M. Early oral feeding compared with delayed oral feeding after cesarean section: a meta-analysis. J Matern Fetal Neonatal Med. 2016;29(3):423-9. doi: 10.3109/14767058.2014.1002765. Epub 2015 Mar 10.
PubMed 25754213Guo J, Long S, Li H, Luo J, Han D, He T. Early versus delayed oral feeding for patients after cesarean. Int J Gynaecol Obstet. 2015 Feb;128(2):100-5. doi: 10.1016/j.ijgo.2014.07.039. Epub 2014 Oct 22.
PubMed 25457588Saad AF, Saoud F, Diken ZM, Hegde S, Kuhlmann MJ, Wen TS, Hankins GD, Saade GR, Costantine MM. Early versus Late Feeding after Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2016 Mar;33(4):415-9. doi: 10.1055/s-0035-1565918. Epub 2015 Oct 19.
PubMed 26479169Craciunas L, Sajid MS, Ahmed AS. Chewing gum in preventing postoperative ileus in women undergoing caesarean section: a systematic review and meta-analysis of randomised controlled trials. BJOG. 2014 Jun;121(7):793-9; discussion 799. doi: 10.1111/1471-0528.12696. Epub 2014 Mar 14.
PubMed 24628729Zhu YP, Wang WJ, Zhang SL, Dai B, Ye DW. Effects of gum chewing on postoperative bowel motility after caesarean section: a meta-analysis of randomised controlled trials. BJOG. 2014 Jun;121(7):787-92. doi: 10.1111/1471-0528.12662. Epub 2014 Mar 14.
PubMed 24629205Shang H, Yang Y, Tong X, Zhang L, Fang A, Hong L. Gum chewing slightly enhances early recovery from postoperative ileus after cesarean section: results of a prospective, randomized, controlled trial. Am J Perinatol. 2010 May;27(5):387-91. doi: 10.1055/s-0029-1243313. Epub 2009 Dec 11.
PubMed 20013603Peleg D, Eberstark E, Warsof SL, Cohen N, Ben Shachar I. Early wound dressing removal after scheduled cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2016 Sep;215(3):388.e1-5. doi: 10.1016/j.ajog.2016.03.035. Epub 2016 Mar 25.
PubMed 27018465Lowder JL, Shackelford DP, Holbert D, Beste TM. A randomized, controlled trial to compare ketorolac tromethamine versus placebo after cesarean section to reduce pain and narcotic usage. Am J Obstet Gynecol. 2003 Dec;189(6):1559-62; discussion 1562. doi: 10.1016/j.ajog.2003.08.014.
PubMed 14710063El-Mazny A, El-Sharkawy M, Hassan A. A prospective randomized clinical trial comparing immediate versus delayed removal of urinary catheter following elective cesarean section. Eur J Obstet Gynecol Reprod Biol. 2014 Oct;181:111-4. doi: 10.1016/j.ejogrb.2014.07.034. Epub 2014 Aug 1.
PubMed 25145762Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.
PubMed 21236454
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery at Cesarean Birth to Improve Postoperative Outcomes and Reduce Postoperative Length of Stay
- ClinicalTrials.gov ID
- NCT02956616
- Acronym / sponsor ID
- ERAC / 2016-6966
- Conditions
- Cesarean Section
- Keywords
- Enhanced Recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Posted 25 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether women randomized to an enhanced recovery program will have improved postoperative outcomes including improved breastfeeding initiation and continuation, reduction in hospital length of stay without compromising patient satisfaction in comparison to standard postoperative recovery interventions.
Detailed description
The investigators hypothesize that an enhanced recovery program which includes several evidence based interventions at the time of cesarean birth in obstetrics will promote early ambulation, resumption of diet and initiation of breastfeeding, and reduce postoperative hospital length of stay.
Enhanced Recovery Protocol Components:
- Provide preoperative education about the perioperative recovery experience including postoperative analgesia, thromboprophylaxis and breastfeeding education
- Minimize preoperative starvation times
- Moderate amount of clears up to 2 hours prior to anesthesia
- Solid foods up to 6-8 hours prior to anesthesia
- Prophylactic antibiotics
- Venous thromboembolism prophylaxis (mechanical) initiated at the time of cesarean birth and continued postoperatively
- Chewing gum (Xylitol) to reduce postoperative ileus
- Routine administration of Non-steroidal anti-inflammatory drug, Ketorolac, 15mg every hour for 24 hours postoperatively to minimize postoperative narcotic use
- Early initiation of feeding after cesarean, immediately for clears, 30 minutes for regular diet as tolerated
- Early removal of urinary catheter (12 hours postoperatively)
- Early removal of dressing (6 hours postoperatively)
- Early mobilization at 12 hours after delivery
- Early skin-to- skin/breastfeeding initiation
- Early incentive spirometry
Currently, patients are encouraged to ambulate on the first post-operative day, but it is largely left up to the patient when to actually begin to ambulate. They are similarly offered a diet on the first postoperative day but are not encouraged to eat. Breastfeeding is more systematically encouraged early as part of Montefiore's effort to get baby friendly designation. And finally, patients are typically discharged on postoperative day number three unless complications arise in the newborn or the mother. As part of this study, patients in both the enhanced recovery and usual care group will be offered the opportunity to be discharged from the hospital on postoperative day number 2 if their recovery is progressing well and if they choose not to leave then they will be encouraged to return home on postoperative day number 3 according to the current standard of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery | Experimental | Drug: ketorolac, Other: Chewing Gum, Procedure: Enhanced Recovery ProtocolPostoperative recovery will follow the usual service protocols as if the patient were not in the study with the exception of components of the enhanced recovery protocol (detailed previously), which will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing. Additionally, participants in this group will receive intravenous ketorolac for pain control and Xylitol chewing gum for improvement of postoperative gastrointestinal function. |
| Routine Perioperative Care | Active comparator | Drug: ketorolacPostoperative recovery will follow the usual service protocols at our institution. Participants in this group may receive intravenous ketorolac (toradol) for pain control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Women undergoing a non-urgent or elective cesarean delivery >37 weeks gestation
Key exclusion criteria (12 listed)
- Women undergoing an urgent or emergent cesarean birth
- Women less than 18 years old
- Patients receiving general anesthesia
- Abnormally adherent placenta (Placenta Accreta) or expected excessive blood loss (Placenta accreta)
- Pre-existing essential hypertension or hypertensive disorders of pregnancy (preeclampsia, eclampsia, HELLP)
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 |
|---|---|---|
| ketorolacAlso: ToradolKetorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins. | Drug | Enhanced Recovery, Routine Perioperative Care |
| Chewing GumAlso: XylitolXylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for a duration of 30 minutes at each time, based on a metanalysis and systematic review. Patient's will be encouraged on its use for return of bowel function. | Other | Enhanced Recovery |
| Enhanced Recovery Protocolenhanced recovery protocol (detailed previously) will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing and standing ketorolac for 24 hours postoperatively. | Procedure or surgery | Enhanced Recovery |
Primary outcome
Discharge on Postoperative Day #2
Time frame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Number of patients discharged on postoperative Day #2
3 secondary outcomes
Postoperative Pain Medication Requirement
Time frame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Breastfeeding Initiation
Time frame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Postoperative Length of Hospital Stay
Time frame: Until patient's day of hospital discharge or a maximum of one month from cesarean delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25794417Wrench IJ, Allison A, Galimberti A, Radley S, Wilson MJ. Introduction of enhanced recovery for elective caesarean section enabling next day discharge: a tertiary centre experience. Int J Obstet Anesth. 2015 May;24(2):124-30. doi: 10.1016/j.ijoa.2015.01.003. Epub 2015 Jan 14.
- Background: PubMed 7936522Brooten D, Roncoli M, Finkler S, Arnold L, Cohen A, Mennuti M. A randomized trial of early hospital discharge and home follow-up of women having cesarean birth. Obstet Gynecol. 1994 Nov;84(5):832-8.
- Background: PubMed 26580836Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
- Background: PubMed 23635626Habib AS, George RB, McKeen DM, White WD, Ituk US, Megalla SA, Allen TK. Antiemetics added to phenylephrine infusion during cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):615-623. doi: 10.1097/AOG.0b013e3182839fee.
- Background: PubMed 24856433Masood SN, Masood Y, Naim U, Masood MF. A randomized comparative trial of early initiation of oral maternal feeding versus conventional oral feeding after cesarean delivery. Int J Gynaecol Obstet. 2014 Aug;126(2):115-9. doi: 10.1016/j.ijgo.2014.02.023. Epub 2014 Apr 29.
- Background: PubMed 25754213Huang H, Wang H, He M. Early oral feeding compared with delayed oral feeding after cesarean section: a meta-analysis. J Matern Fetal Neonatal Med. 2016;29(3):423-9. doi: 10.3109/14767058.2014.1002765. Epub 2015 Mar 10.
- Background: PubMed 25457588Guo J, Long S, Li H, Luo J, Han D, He T. Early versus delayed oral feeding for patients after cesarean. Int J Gynaecol Obstet. 2015 Feb;128(2):100-5. doi: 10.1016/j.ijgo.2014.07.039. Epub 2014 Oct 22.
- Background: PubMed 26479169Saad AF, Saoud F, Diken ZM, Hegde S, Kuhlmann MJ, Wen TS, Hankins GD, Saade GR, Costantine MM. Early versus Late Feeding after Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2016 Mar;33(4):415-9. doi: 10.1055/s-0035-1565918. Epub 2015 Oct 19.
- Background: PubMed 24628729Craciunas L, Sajid MS, Ahmed AS. Chewing gum in preventing postoperative ileus in women undergoing caesarean section: a systematic review and meta-analysis of randomised controlled trials. BJOG. 2014 Jun;121(7):793-9; discussion 799. doi: 10.1111/1471-0528.12696. Epub 2014 Mar 14.
- Background: PubMed 24629205Zhu YP, Wang WJ, Zhang SL, Dai B, Ye DW. Effects of gum chewing on postoperative bowel motility after caesarean section: a meta-analysis of randomised controlled trials. BJOG. 2014 Jun;121(7):787-92. doi: 10.1111/1471-0528.12662. Epub 2014 Mar 14.
- Background: PubMed 20013603Shang H, Yang Y, Tong X, Zhang L, Fang A, Hong L. Gum chewing slightly enhances early recovery from postoperative ileus after cesarean section: results of a prospective, randomized, controlled trial. Am J Perinatol. 2010 May;27(5):387-91. doi: 10.1055/s-0029-1243313. Epub 2009 Dec 11.
- Background: PubMed 27018465Peleg D, Eberstark E, Warsof SL, Cohen N, Ben Shachar I. Early wound dressing removal after scheduled cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2016 Sep;215(3):388.e1-5. doi: 10.1016/j.ajog.2016.03.035. Epub 2016 Mar 25.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ketorolac, Chewing Gum and Enhanced Recovery Protocol in people with Cesarean Section, run by Montefiore Medical Center 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 1 inclusion and 12 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 25 Apr 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Discharge on Postoperative Day #2 (time frame: Until patient's day of hospital discharge or a maximum of one month from cesarean 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 NCT02956616, which also lists 16 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 25 Apr 2019.