Complications; Cesarean SectionNCT02332278
Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.
A study testing Early feeding and Late feeding in people with Complications; Cesarean Section, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
To determine the effect in the post operative period of early feeding (4 hours after surgery) vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean section. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Complications; Cesarean Section
- What is being tested?
- Early feeding and Late feeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 sitePanama
- Study dates
- Jun 2014to Dec 2014
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cesarean section with regional anesthesia, regardless of gestational age.
Who cannot join
- Use of magnesium sulphate
- General anesthesia
- Pre gestational or gestational diabetes
- Bowel injury during surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Oral Feeding Versus Traditional Postoperative Care After Uncomplicated Cesarean Section. A Randomized Controlled Trial.
To determine the effect in the post operative period of early feeding (4 hours after surgery) vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean section.
- Conditions
- Complications; Cesarean Section
- Being tested
- Early feeding, Late feeding
- Keywords
- Cesarean section, Early feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early feedingProcedure or surgery
Fluid diet four hours after cesarean section
Late feedingProcedure or surgery
Fluid diet 12 hours after cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Early feeding | Experimental | Early feeding (fluid diet), four hours after cesarean section. Receives: Procedure: Early feeding |
| Late feeding | Active comparator | Late feeding (fluid diet) 12 hours after cesarean section. Receives: Procedure: Late feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adynamic ileus
Presence of signs of adynamic ileus (nausea, vomiting, abdominal distention) after feeding
Measured: 72 hours
Secondary outcomes (2)
Post operative pain
Level of pain, using a visual scale (12, 24, 48 and 72 hours after surgery)
Measured: 72 hours
Satisfaction
Personal satisfaction, using a numeric scale (12, 24, 48 and 72 hours after surgery)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies 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
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Ana Lia Becerra, MD, Principal investigator, Saint Thomas Hospital, PanamaOsvaldo Reyes, MD, Principal investigator, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332278
- Sponsor's protocol ID
- MHST2014-08
- Status last verified
- Jan 2015
- First submitted
- 4 Jan 2015
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oral Feeding Versus Traditional Postoperative Care After Uncomplicated Cesarean Section. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02332278
- Acronym / sponsor ID
- MHST2014-08
- Conditions
- Complications; Cesarean Section
- Keywords
- Cesarean section, Early feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jan 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.
To determine the effect in the post operative period of early feeding (4 hours after surgery) vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean section.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early feeding | Experimental | Procedure: Early feedingEarly feeding (fluid diet), four hours after cesarean section. |
| Late feeding | Active comparator | Procedure: Late feedingLate feeding (fluid diet) 12 hours after cesarean section. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cesarean section with regional anesthesia, regardless of gestational age.
Key exclusion criteria (4 listed)
- Use of magnesium sulphate
- General anesthesia
- Pre gestational or gestational diabetes
- Bowel injury during surgery
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 feedingFluid diet four hours after cesarean section | Procedure or surgery | Early feeding |
| Late feedingFluid diet 12 hours after cesarean section | Procedure or surgery | Late feeding |
Primary outcome
Adynamic ileus
Time frame: 72 hours
Presence of signs of adynamic ileus (nausea, vomiting, abdominal distention) after feeding
2 secondary outcomes
Post operative pain
Time frame: 72 hours
Satisfaction
Time frame: 72 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 6 Jan 2015.
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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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.
Ana Lia Becerra, MD principal investigator
Saint Thomas Hospital, Panama
Osvaldo Reyes, MD principal investigator
Saint Thomas Hospital, Panama
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 feeding and Late feeding in people with Complications; Cesarean Section, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 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 6 Jan 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 Panama. 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?
Adynamic ileus (time frame: 72 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 Jan 2015.