Gastrointestinal Motility and Defaecation ConditionsNCT02630810
Early Versus Late Hydration After Cesarean Section (CS)
A study testing Early oral hydration and Delayed oral hydration in people with Gastrointestinal Motility and Defaecation Conditions, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
This study evaluates the effect of early oral hydration on bowel movement after CS, it includes 2 groups: study group participants receive 100 ml water after 1hr from the end of CS, while the others receive water after 6hrs from the end of CS. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Motility and Defaecation Conditions
- What is being tested?
- Early oral hydration and Delayed oral hydration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Dec 2015
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- uncomplicated elective or emergency lower segment Caesarean section
- average blood loss during and after cs
- regional anaesthesia
- primary or recurrent CS
Who cannot join
- surgical complications esp; intestinal injury
- postpartum hemorrhage
- medical disorder with pregnancy eg. hypertension, diabetes mellitus
- factors that may increase risk of postpartum hemorrhage as twins pregnancy, polyhydramnios and anemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Late Oral Hydration After Cesarean Section: A Randomized Controlled Study
This study evaluates the effect of early oral hydration on bowel movement after CS, it includes 2 groups: study group participants receive 100 ml water after 1hr from the end of CS, while the others receive water after 6hrs from the end of CS.
Read the detailed description
Traditionally, oral intake after CS was depend on insurance of intestinal movement, since uncomplicated CS does not affect the intestine and the mother needs to care of her infants, lactates, discharged from hospital, early oral hydration may enhance bowel movement, so the investigators need to evaluate the safety of early oral hydration after CS.
This study compare the effects of introducing water during the 1st hour or after 6 hours on bowel movement after CS.
- Being tested
- Early oral hydration, Delayed oral hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early oral hydrationOther
starting oral hydration 1 hour following Cesarean Section using 100 ml clear water
Delayed oral hydrationOther
starting oral hydration 6 hours following Cesarean Section using 100 ml clear water
| Study group | Role | What they receive |
|---|---|---|
| Early oral hydration | Experimental | Early oral intake of 100 ml clear unsweetened water 1 hour following the Cesarean Section, then upon patient's desire, then starting semisolid, solid food when participant passed flatus. Receives: Other: Early oral hydration |
| Delayed oral hydration | Active comparator | Oral intake of 100 ml clear unsweetened water after 6 hours from the end of CS then upon patient's request,then starting semisolid, solid food when participant passed flatus. Receives: Other: Delayed oral hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 1st audible intestinal sound
Auscultating intestinal sounds (using stethoscope) hourly for the first 12 hours after Cesarean Section till intestinal sounds are audible.
Measured: First 12 hours after Cesarean Section
Secondary outcomes (3)
Time to passage of first flatus
Recording the timing of passage of first flatus following Cesarean Section (up to the first 48 hours).
Measured: Up to 48 hours following the Cesarean Section
Time to first bowel motion
Recording the first time the pass stools after cesarean section (up to the first 72 hours).
Measured: Up to 3 days (72 hours) following Cesarean Section
time to 1st breast feed
Recording the first time to breastfeed after cesarean section (up to the first 24 hours).
Measured: First 24 hours after the Cesarean Section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Motility and Defaecation ConditionsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMR HELMY YEHIA, Ain Shams Maternity Hospital
- Investigators
- Amr Yehia, Lecturer, Principal investigator, ainshams maternity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630810
- Sponsor's protocol ID
- EVLHACS 1
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Oral Hydration After Cesarean Section: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02630810
- Acronym / sponsor ID
- EVLHACS 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Dec 2015 (estimated)
- 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.
This study evaluates the effect of early oral hydration on bowel movement after CS, it includes 2 groups: study group participants receive 100 ml water after 1hr from the end of CS, while the others receive water after 6hrs from the end of CS.
Detailed description
Traditionally, oral intake after CS was depend on insurance of intestinal movement, since uncomplicated CS does not affect the intestine and the mother needs to care of her infants, lactates, discharged from hospital, early oral hydration may enhance bowel movement, so the investigators need to evaluate the safety of early oral hydration after CS.
This study compare the effects of introducing water during the 1st hour or after 6 hours on bowel movement after CS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early oral hydration | Experimental | Other: Early oral hydrationEarly oral intake of 100 ml clear unsweetened water 1 hour following the Cesarean Section, then upon patient's desire, then starting semisolid, solid food when participant passed flatus. |
| Delayed oral hydration | Active comparator | Other: Delayed oral hydrationOral intake of 100 ml clear unsweetened water after 6 hours from the end of CS then upon patient's request,then starting semisolid, solid food when participant passed flatus. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- uncomplicated elective or emergency lower segment Caesarean section
- average blood loss during and after cs
- regional anaesthesia
- primary or recurrent CS
Key exclusion criteria (4 listed)
- surgical complications esp; intestinal injury
- postpartum hemorrhage
- medical disorder with pregnancy eg. hypertension, diabetes mellitus
- factors that may increase risk of postpartum hemorrhage as twins pregnancy, polyhydramnios and anemia
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 |
|---|---|---|
| Early oral hydrationstarting oral hydration 1 hour following Cesarean Section using 100 ml clear water | Other | Early oral hydration |
| Delayed oral hydrationstarting oral hydration 6 hours following Cesarean Section using 100 ml clear water | Other | Delayed oral hydration |
Primary outcome
Time to 1st audible intestinal sound
Time frame: First 12 hours after Cesarean Section
Auscultating intestinal sounds (using stethoscope) hourly for the first 12 hours after Cesarean Section till intestinal sounds are audible.
3 secondary outcomes
Time to passage of first flatus
Time frame: Up to 48 hours following the Cesarean Section
Time to first bowel motion
Time frame: Up to 3 days (72 hours) following Cesarean Section
time to 1st breast feed
Time frame: First 24 hours after the Cesarean Section
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 15 Dec 2015.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Motility and Defaecation Conditions
Recruiting
"The Effect of Abdominal Massage on Gastrointestinal Functions in Mechanically Ventilated Patients Receiving Enteral Nutrition in Intensive Care"
Defecation Disorder, Gastrointestinal Motility Disorder
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.
Amr Yehia, Lecturer principal investigator
ainshams maternity hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early oral hydration and Delayed oral hydration in people with Gastrointestinal Motility and Defaecation Conditions, run by Ain Shams Maternity Hospital 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 4 inclusion and 4 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 15 Dec 2015. 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?
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?
Time to 1st audible intestinal sound (time frame: First 12 hours after Cesarean Section). 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 15 Dec 2015.