Cesarean Section ComplicationsNCT03732404
Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section
A study testing preoperative carbohydrate loading in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- preoperative carbohydrate loading
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Aug 2021
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women undergoing elective caesarean section
- Term gestational age (37+0 to 41+6 weeks)
- Singleton gestation
Who cannot join
- Women with gestational diabetes and diabetes mellitus
- Fetal intrauterine growth restriction
- Ante-natally detected congenital anomaly which will require admission to the neonatal nursery
- Women who received steroids within the past 7 days prior to delivery
- Women who did not complete a gestational diabetes screening test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section. A Double-Blind Placebo-controlled Study
Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.
Read the detailed description
Carbohydrate (sugar-containing) nutritional supplements have become a routine part of the package of care for people undergoing planned surgical procedures. the investigator wanted to discover whether carbohydrate supplements are a useful part of care packages used by doctors to improve recovery after planned cesarean section.
- Conditions
- Cesarean Section Complications
- Being tested
- preoperative carbohydrate loading, Placebo
- Keywords
- Enhanced recovery after surgery, Preoperative carbohydrate drink, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative carbohydrate loadingDrug
Also called Experimental
Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia
PlaceboDrug
Also called Placebo Comparator
The control group will receive plain water with the same volume and timing of treatment.
| Study group | Role | What they receive |
|---|---|---|
| preoperative carbohydrate loading | Experimental | Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia Receives: Drug: preoperative carbohydrate loading |
| Placebo | Placebo comparator | The control group will receive plain water with the same volume and timing of treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Number of days in the hospital for each participant between the groups.
Measured: 3 weeks
Secondary outcomes (4)
number of participants experienced nausea
Number of participants experienced nausea
Measured: 24 hours postoperative
Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale
100 mm visual analogue scales for hunger, thirst, anxiety, fatigue and nausea administered on the morning of surgery prior to morning beverage consumption and 60 minutes after the beverage. All measurements will be assessed using the same scale starting at 0 to 100mm with 0 being the worst and 100 being the best and average being 85.
Measured: ist 24 hours postoperative
neonatal blood glucose concentration at four and ten hours of age
measure neonatal blood glucose level at four and ten hours of age
Measured: 24 hours post operative
Neonates with plasma glucose level of less than 45 mg/dL between the groups
First umbilical cord blood sample will be taken for plasma glucose level of less than 45 mg/dL to note hypoglycemia between the groups.
Measured: ist 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Jun 2021
- Study completion1 Aug 2021
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, placebo-controlled, study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732404
- Sponsor's protocol ID
- aswu/197/7/18
- Status last verified
- Aug 2021
- First submitted
- 3 Nov 2018
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section. A Double-Blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03732404
- Acronym / sponsor ID
- aswu/197/7/18
- Conditions
- Cesarean Section Complications
- Keywords
- Enhanced recovery after surgery, Preoperative carbohydrate drink, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 6 Nov 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.
Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.
Detailed description
Carbohydrate (sugar-containing) nutritional supplements have become a routine part of the package of care for people undergoing planned surgical procedures. the investigator wanted to discover whether carbohydrate supplements are a useful part of care packages used by doctors to improve recovery after planned cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, placebo-controlled, study.
| Arm | Type | Receives |
|---|---|---|
| preoperative carbohydrate loading | Experimental | Drug: preoperative carbohydrate loadingPatients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia |
| Placebo | Placebo comparator | Drug: PlaceboThe control group will receive plain water with the same volume and timing of treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women undergoing elective caesarean section
- Term gestational age (37+0 to 41+6 weeks)
- Singleton gestation
Key exclusion criteria (5 listed)
- Women with gestational diabetes and diabetes mellitus
- Fetal intrauterine growth restriction
- Ante-natally detected congenital anomaly which will require admission to the neonatal nursery
- Women who received steroids within the past 7 days prior to delivery
- Women who did not complete a gestational diabetes screening test
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 |
|---|---|---|
| preoperative carbohydrate loadingAlso: ExperimentalPatients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia | Drug | preoperative carbohydrate loading |
| PlaceboAlso: Placebo ComparatorThe control group will receive plain water with the same volume and timing of treatment. | Drug | Placebo |
Primary outcome
Length of hospital stay
Time frame: 3 weeks
Number of days in the hospital for each participant between the groups.
4 secondary outcomes
number of participants experienced nausea
Time frame: 24 hours postoperative
Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale
Time frame: ist 24 hours postoperative
neonatal blood glucose concentration at four and ten hours of age
Time frame: 24 hours post operative
Neonates with plasma glucose level of less than 45 mg/dL between the groups
Time frame: ist 24 hours postoperative
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 2021.
- Individual participant dataSharing planned: Undecided
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.
hany f sallam, md principal investigator
Aswan University 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 preoperative carbohydrate loading in people with Cesarean Section Complications, run by Aswan University 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 3 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 2021. 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. Some participants in this study may receive a placebo. 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?
Length of hospital stay (time frame: 3 weeks). 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 2021.