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NCT Number: NCT03732404

Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section

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.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University

Aswān, 81528, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women undergoing elective caesarean section
  • Term gestational age (37+0 to 41+6 weeks)
  • Singleton gestation

Exclusion criteria

  • 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

Treatment and study plan

preoperative carbohydrate loading

Drug

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

Other names: Experimental

Placebo

Drug

The control group will receive plain water with the same volume and timing of treatment.

Other names: Placebo Comparator

Primary outcomes

  1. Length of hospital stay

    Time frame: 3 weeks

    Number of days in the hospital for each participant between the groups.

Secondary outcomes

  1. number of participants experienced nausea

    Time frame: 24 hours postoperative

    Number of participants experienced nausea

  2. 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

    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.

  3. neonatal blood glucose concentration at four and ten hours of age

    Time frame: 24 hours post operative

    measure neonatal blood glucose level at four and ten hours of age

  4. Neonates with plasma glucose level of less than 45 mg/dL between the groups

    Time frame: ist 24 hours postoperative

    First umbilical cord blood sample will be taken for plasma glucose level of less than 45 mg/dL to note hypoglycemia between the groups.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

Effects of Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section. A Double-Blind Placebo-controlled Study

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 6, 2018
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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