Cesarean SectionNCT03566498
The Effect Of Immediate Versus Early Oral Hydration On Caesarean Section Post Operative Outcomes
A study testing Immediate hydration and Early hydration in people with Cesarean Section, run by Ain Shams University.
Trial summary
The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Immediate hydration and Early hydration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to Apr 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Uncomplicated pregnancy.
- Uncomplicated elective or emergency Caesarean section under regional anesthesia
Who cannot join
- • Having medical disorders in the form of: hypertension, DM, and Hepatic disorders.
- Having bleeding disorders.
- Having intraoperative bowel or bladder injury.
- Having intraoperative or immediate postoperative severe bleeding.
- Having chronic gastrointestinal problems, like chronic constipation, peptic ulcer, esophagitis, hiatus hernia or irritable bowel syndrome.
- Having abdominal adhesions
About this study
The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section
Read the detailed description
The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section on the following post-operative outcomes:
- Post-operative nausea, vomiting, abdominal distention and abdominal cramps.
- Return of intestinal movements.
- Duration of intravenous fluid administration.
- Duration of hospital stay.
- Participant satisfaction
- Conditions
- Cesarean Section
- Being tested
- Immediate hydration, Early hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate hydrationDietary supplement
They will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements
Early hydrationDietary supplement
They will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements.
| Study group | Role | What they receive |
|---|---|---|
| Immediate hydration | Experimental | They will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements. Receives: Dietary Supplement: Immediate hydration |
| Early hydration | Active comparator | They will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements. Receives: Dietary Supplement: Early hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum vomiting
through a questionnaire patients were asked if they had vomiting or not and the nomber of attacks of vomitting
Measured: 48 hours
Secondary outcomes (4)
Return of intestinal movements
through physical examination and auscultation of the intestinal sounds
Measured: 24 hours
Duration of intravenous fluid administration
Measured: 24 hours
Duration of hospital stay
Measured: 48 hours
Participant satisfaction
through a questionnaire patients were asked about degree of satisfaction
1- satisfied 2- neutral 3- not satisfied
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 posted25 Jun 2018
- Study start1 Aug 2016
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Shafy El Shahawy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566498
- Sponsor's protocol ID
- IMOH
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Immediate Versus Early Oral Hydration On Caesarean Section Post Operative Outcomes
- ClinicalTrials.gov ID
- NCT03566498
- Acronym / sponsor ID
- IMOH
- Conditions
- Cesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 25 Jun 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.
The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section
Detailed description
The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section on the following post-operative outcomes:
- Post-operative nausea, vomiting, abdominal distention and abdominal cramps.
- Return of intestinal movements.
- Duration of intravenous fluid administration.
- Duration of hospital stay.
- Participant satisfaction
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate hydration | Experimental | Dietary Supplement: Immediate hydrationThey will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements. |
| Early hydration | Active comparator | Dietary Supplement: Early hydrationThey will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • Uncomplicated pregnancy.
Key exclusion criteria (6 listed)
- • Having medical disorders in the form of: hypertension, DM, and Hepatic disorders.
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 |
|---|---|---|
| Immediate hydrationThey will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements | Dietary supplement | Immediate hydration |
| Early hydrationThey will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements. | Dietary supplement | Early hydration |
Primary outcome
Postpartum vomiting
Time frame: 48 hours
through a questionnaire patients were asked if they had vomiting or not and the nomber of attacks of vomitting
4 secondary outcomes
Return of intestinal movements
Time frame: 24 hours
Duration of intravenous fluid administration
Time frame: 24 hours
Duration of hospital stay
Time frame: 48 hours
Participant satisfaction
Time frame: 48 hours
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 25 Jun 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate hydration and Early hydration in people with Cesarean Section, run by Ain Shams University.
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 2 inclusion and 6 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Postpartum vomiting (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 25 Jun 2018.