Cesarean Section ComplicationsNCT03355378
Short Versus Standard Post-operative Stay After Elective Cesarean Delivery
A study testing gum chewing in people with Cesarean Section Complications, run by Assiut University at 1 site in Egypt.
Trial summary
After major open abdominal surgery, transient paralytic ileus usually follows. It has been suggested that stimulation of pain fibers, excessive sympathetic tone, and the release of inhibitory neurotransmitters from bowel wall associated with bowel manipulation and peritoneal irritation are responsible mechanisms. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- gum chewing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to Dec 2018
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women is sure of her last menstrual period or documented early pregnancy ultrasound.
- Women aged 20-35 years.
- Women with Body mass index18-22 kg/m2.
- Estimated gestational age is ranging between 37-40 weeks gestation.
- Accepting to participate in the study.
Who cannot join
- Smoker ≥ 11 cigarettes/day.
- Caesarean hysterectomy .
- Surgical management of severe postpartum haemorrhage .
- History of bowel obstruction , inflammatory bowel disease .
- Previous abdominal or pelvic radiation
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Faculty of Medicine
Asyut
Ahmed Abbas, MD, 00201003385183, bmr90@hotmail.com
About this study
After major open abdominal surgery, transient paralytic ileus usually follows. It has been suggested that stimulation of pain fibers, excessive sympathetic tone, and the release of inhibitory neurotransmitters from bowel wall associated with bowel manipulation and peritoneal irritation are responsible mechanisms. There have been concerns that early postoperative oral feeding would lead to vomiting with subsequent aspiration pneumonia, anastomotic leakage, and wound dehiscence.
- Conditions
- Cesarean Section Complications
- Being tested
- gum chewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gum chewingProcedure or surgery
chewing gum orally for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | gum chewing during spinal anesthesia and early ambulation Receives: Procedure: gum chewing |
| Control group | No intervention | no gum chewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of hospital stay
time of postoperative recovery of gastrointestinal tract
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Nov 2017
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355378
- Sponsor's protocol ID
- POSCS
- Status last verified
- Jul 2018
- First submitted
- 22 Nov 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Standard Post-operative Stay After Elective Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03355378
- Acronym / sponsor ID
- POSCS
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Nov 2017 (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.
After major open abdominal surgery, transient paralytic ileus usually follows. It has been suggested that stimulation of pain fibers, excessive sympathetic tone, and the release of inhibitory neurotransmitters from bowel wall associated with bowel manipulation and peritoneal irritation are responsible mechanisms. There have been concerns that early postoperative oral feeding would lead to vomiting with subsequent aspiration pneumonia, anastomotic leakage, and wound dehiscence.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: gum chewinggum chewing during spinal anesthesia and early ambulation |
| Control group | No intervention | –no gum chewing |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women is sure of her last menstrual period or documented early pregnancy ultrasound.
- Women aged 20-35 years.
- Women with Body mass index18-22 kg/m2.
- Estimated gestational age is ranging between 37-40 weeks gestation.
- Accepting to participate in the study.
Key exclusion criteria (5 listed)
- Smoker ≥ 11 cigarettes/day.
- Caesarean hysterectomy .
- Surgical management of severe postpartum haemorrhage .
- History of bowel obstruction , inflammatory bowel disease .
- Previous abdominal or pelvic radiation
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 |
|---|---|---|
| gum chewingchewing gum orally for 30 minutes | Procedure or surgery | study group |
Primary outcome
duration of hospital stay
Time frame: 48 hours
time of postoperative recovery of gastrointestinal tract
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gum chewing in people with Cesarean Section Complications, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jul 2018. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of hospital stay (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2018.