Gastrointestinal Motility and Defecation ConditionsNCT03442634
Early Versus Traditional Oral Hydration After Cesarean Section
A study testing Early Hydration and Traditional Oral Hydration in people with Gastrointestinal Motility and Defecation Conditions, run by Ain Shams University at 1 site in Egypt.
Trial summary
this study helps us to compare and evaluate prospectively the benefits and safety of early hydration on bowel movement after cesarean section it includes two groups, a control group and a study group. 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 Defecation Conditions
- What is being tested?
- Early Hydration and Traditional Oral Hydration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 30 Jun 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Term Singleton Pregnancy.
- Uncomplicated Elective Cesarean Section.
- Time of Cesarean Section doesn't exceed 90 minutes.
- Average blood loss during and after cesarean section (doesn't exceed 1000cc).
- All patients will be under spinal anesthesia.
Who cannot join
- Postpartum Hemorrhage.
- Surgical Complications Such as intestinal injury.
- Medical disorders such as Diabetes and Hypertension
- Factors that may influence postpartum blood loss as anemia, multiple pregnancy and polyhydraminos.
- Use of tocolytic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Traditional Oral Hydration After Cesarean Section; A Randomized Clinical Trial
this study helps us to compare and evaluate prospectively the benefits and safety of early hydration on bowel movement after cesarean section it includes two groups, a control group and a study group. the study group will get 200 ml of sugar free water within 1 hour after cs while the control group will get 200 ml of sugar free water 6 hours after cs
Read the detailed description
Traditionally, patients are not given fluids or food after cesarean sections until bowel function returns as evidenced by bowel sounds, passage of stool or flatus since , uneventful (uncomplicated) cesarean sections have no effect on intestinal functions and with putting in minds the need of the mother for early hydration , movement , breast feeding and early discharge; that is why we are investigating the effectiveness and safety of early oral hydration after cesarean sections
- Being tested
- Early Hydration, Traditional Oral Hydration
- Keywords
- bowel movements, cesarean section, oral hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early HydrationOther
Also called Early Oral Hydration
this group will start oral hydration within 1 hour after cesarean section
Traditional Oral HydrationOther
Also called Delayed Oral Hydration
this group will start oral hydration 6 hours after cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Early Hydration Group | Experimental | this study group will get 200 ml of sugar free water within 1 hour after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Early Oral Hydration Receives: Other: Early Hydration |
| Traditional Hydration Group | Active comparator | this study group will get 200 ml of sugar free water after 6 hours after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Traditional Oral Hydration Receives: Other: Traditional Oral Hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
audible intestinal sounds
auscultation of intestinal sounds hourly for the first 12 hours after cesarean section
Measured: first 12 hours after cesarean section
Secondary outcomes (9)
postoperative anorexia, nausea and vomiting
recording the incidence of git upset symptoms in the first 24 hours after cesarean section
Measured: first 24 hours after cesarean section
time for first breast feeding
recording the time of first breast-feed
Measured: first 24 hours after cesarean section
abdominal distension
recording the incidence of abdominal distension after cesarean section
Measured: first 24 hours after cesarean section
amount of given intravenous fluids
recording amount in ml of given iv fluids
Measured: up to 24 hours after cesarean section
need for pain analgesics
recording the amount of pain analgesia needed after cesarean section
Measured: up to 24 hours after cesarean section
length of hospital stay
recording the length of patients' stay at hospital
Measured: up to 48 hours after cesarean section
satisfaction measured with a visual analogue scale before patient discharge
measuring satisfaction level after cesarean section
Measured: first 6 hours after cesarean section
time to first flatus
recording the time at which the patient had its first flatus
Measured: up to 48 hours after cesarean section
time to first bowel movement
recording the time at which the patient had her first bowel motion
Measured: up to 72 hours after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Motility and Defecation 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Mohamed Mostafa, Ain Shams University
- Investigators
- Bassem A Islam, Lecturer, Study director, Ain Shams Maternity HospitalKarim A Wahba, Professor, Study director, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442634
- Sponsor's protocol ID
- cshydration
- Status last verified
- Aug 2018
- First submitted
- 16 Feb 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Traditional Oral Hydration After Cesarean Section; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03442634
- Acronym / sponsor ID
- cshydration
- Keywords
- bowel movements, cesarean section, oral hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 Feb 2018 (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.
this study helps us to compare and evaluate prospectively the benefits and safety of early hydration on bowel movement after cesarean section it includes two groups, a control group and a study group. the study group will get 200 ml of sugar free water within 1 hour after cs while the control group will get 200 ml of sugar free water 6 hours after cs
Detailed description
Traditionally, patients are not given fluids or food after cesarean sections until bowel function returns as evidenced by bowel sounds, passage of stool or flatus since , uneventful (uncomplicated) cesarean sections have no effect on intestinal functions and with putting in minds the need of the mother for early hydration , movement , breast feeding and early discharge; that is why we are investigating the effectiveness and safety of early oral hydration after cesarean sections
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Hydration Group | Experimental | Other: Early Hydrationthis study group will get 200 ml of sugar free water within 1 hour after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Early Oral Hydration |
| Traditional Hydration Group | Active comparator | Other: Traditional Oral Hydrationthis study group will get 200 ml of sugar free water after 6 hours after cesarean section followed by oral hydration as per patients' desire then starting semisolid and solid foods when patients are open bowel Intervention: Traditional Oral Hydration |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Term Singleton Pregnancy.
- Uncomplicated Elective Cesarean Section.
- Time of Cesarean Section doesn't exceed 90 minutes.
- Average blood loss during and after cesarean section (doesn't exceed 1000cc).
- All patients will be under spinal anesthesia.
Key exclusion criteria (5 listed)
- Postpartum Hemorrhage.
- Surgical Complications Such as intestinal injury.
- Medical disorders such as Diabetes and Hypertension
- Factors that may influence postpartum blood loss as anemia, multiple pregnancy and polyhydraminos.
- Use of tocolytic drugs
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 HydrationAlso: Early Oral Hydrationthis group will start oral hydration within 1 hour after cesarean section | Other | Early Hydration Group |
| Traditional Oral HydrationAlso: Delayed Oral Hydrationthis group will start oral hydration 6 hours after cesarean section | Other | Traditional Hydration Group |
Primary outcome
audible intestinal sounds
Time frame: first 12 hours after cesarean section
auscultation of intestinal sounds hourly for the first 12 hours after cesarean section
9 secondary outcomes
postoperative anorexia, nausea and vomiting
Time frame: first 24 hours after cesarean section
time for first breast feeding
Time frame: first 24 hours after cesarean section
abdominal distension
Time frame: first 24 hours after cesarean section
amount of given intravenous fluids
Time frame: up to 24 hours after cesarean section
need for pain analgesics
Time frame: up to 24 hours after cesarean section
length of hospital stay
Time frame: up to 48 hours after cesarean section
satisfaction measured with a visual analogue scale before patient discharge
Time frame: first 6 hours after cesarean section
time to first flatus
Time frame: up to 48 hours after cesarean section
time to first bowel movement
Time frame: up to 72 hours after 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 9 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Motility and Defecation 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.
Bassem A Islam, Lecturer study director
Ain Shams Maternity Hospital
Karim A Wahba, Professor study director
Ain Shams 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 Hydration and Traditional Oral Hydration in people with Gastrointestinal Motility and Defecation Conditions, run by Ain Shams 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: finished, as of the sponsor's last update on 9 Aug 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?
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?
audible intestinal sounds (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 9 Aug 2018.