NCT04159948

Brief Summary

Prior to caesarean section, patients should fast from solid food for 6 hours and from clear fluids for 2 hours. Carbohydrate drinks can also be consumed up to 2 hours before surgery. These drinks have been shown to improve patient well-being after surgery and may potentially improve the neonatal blood glucose level after delivery and reduce the risk of a low blood glucose level. This study aims to assess the influence of pre-operative carbohydrate drinks on blood glucose levels of the baby at delivery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

November 8, 2019

Last Update Submit

July 30, 2021

Conditions

FastingCesarean Delivery Affecting FetusGlucose, Low Blood

Keywords

Carbodydrate drink

Outcome Measures

Primary Outcomes (1)

  • Neonatal cord blood glucose

    A blood sample of the neonatal cord will be checked immediately after delivery.

    0 hours

Secondary Outcomes (14)

  • Neonate tolerating 1st oral feeding.

    0-2 hours

  • Number of neonatal rescue oral glucose sachets given.

    6 hours

  • Neonate requiring ICU admission and treatment for hypoglycemia

    6 hours

  • Maternal blood glucose

    0 hours

  • Maternal urinary ketones

    0 hours

  • +9 more secondary outcomes

Study Arms (3)

Water

PLACEBO COMPARATOR

Patients will be allowed to drink water up to 2 hours before their caesarean section.

Dietary Supplement: Carbohydrate drink

Carbohydrate drink

ACTIVE COMPARATOR

Patients will be allowed to drink a designated carbohydrate drink up to 2 hours before their caesarean section.

Dietary Supplement: Carbohydrate drink

Apple juice

ACTIVE COMPARATOR

Patients will be allowed to drink apple juice up to 2 hours before their caesarean section.

Dietary Supplement: Carbohydrate drink

Interventions

Carbohydrate drinkDIETARY_SUPPLEMENT

This is a commercially available "pre-op" carbohydrate drink used in enhanced recovery programmes.

Apple juiceCarbohydrate drinkWater

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective caesarean section for singleton pregnancy under neuraxial anaesthesia.
  • Subjects able to give informed consent and willing to comply with the study protocol.
  • Subjects must be greater than 18 years old.

You may not qualify if:

  • Diabetes Mellitus - including gestational diabetes.
  • Known foetal abnormality.
  • General anaesthesia.
  • Gestation \< 37 weeks.
  • Steroids received within 4 days of delivery.
  • Low birth weight 2.5 kg (IUGR)
  • BMI \> 40 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coombe Women and Infants University Hospital

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Terry Tan

    Head of Department of Anaesthesia CWIUH

    STUDY DIRECTOR

Central Study Contacts

Ruairi Irwin

CONTACT

+353877497263r.irwin1987@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Patient will not be blinded to which arm they have been allocated to. Outcome assessors will be unaware of group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 arms with equal allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anaesthesia SpR

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 12, 2019

Study Start

January 20, 2020

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations

IE(1)