Comparison of 'Sip Til Send' Regimens Prior to Elective Caesarean Delivery Using Bedside Gastric Ultrasound

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe Rotunda Hospital

About this trial

'Sip Til send' is a liberal drinking policy that replaces fasting before a caesarean delivery, meaning that women waiting in hospital can freely drink sips of water until they are called from the ward for their delivery. Studies has shown that 'Sip Til send' is safe and it improves the experience around surgery. Separate from this, drinking carbohydrate-rich drinks at specified time intervals before surgery is also recommended by international guidelines as part of a package of care aimed at enhancing recovery from surgery, and studies demonstrate that carbohydrate drinks significantly lower hunger sensation before caesarean delivery. The aim of this study is to combine these two interventions and compare the effects of sipping water against sipping carbohydrate drinks whilst waiting for a caesarean delivery and look at the stomach contents before delivery to ensure it is a safe practice and look at how women rate the quality of their recovery to see which practice is preferred. We will recruit women due to have an elective caesarean delivery whilst awake with a spinal anaesthetic at the Rotunda Hospital and only include those who are fully fasted on their arrival and would be candidates for the current 'Sip Til Send' policy. They will then be assigned to one of two groups, the "water" group who will be encouraged to sip water whilst waiting for surgery, and the "carbohydrate" group who will be encouraged to sip a standardised carbohydrate-rich drink instead. Using a bedside ultrasound machine, we will image the stomach and estimate the volume of liquid contents on two occasions; first, following recruitment to the study when fully fasted and before starting 'Sip Til Send', and second is immediately prior to surgery. Fluid intake will be closely monitored, and all participants will be asked to complete a short questionnaire the day after their delivery that asks them to rate aspects of their recovery. Participants and their newborns will not undergo any additional invasive testing for the study. Participants and their newborns will not undergo any additional invasive testing for the study, but consent will be sought to test women's urine for ketones (collected from the catheter bag during surgery). Medical notes will also be looked at after discharge to identify adverse outcomes such as nausea or vomiting during surgery and low blood sugar in the newborn. The study should run for approximately 3 to 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Planned caesarean delivery under regional anaesthesia

Adhered to national fasting guidance of 6 hours for food and 2 hours for clear fluids

Eligible for Sip Til Send

Disqualifiers

Planned general anaesthesia

Emergency or urgent caesarean delivery

Not fasted at time of recruitment

Unable to visualise stomach or Perlas 2 stomach identified at time of recruitment

Trial design

Design model

Parallel

Treatments tested in this trial

  • The carbohydrate group represent the interventional group and will utilise the standard carbohydrate-rich drink

    Drug

    the "carbohydrate" group will be encouraged to sip a standardised carbohydrate-rich drink at a maximum rate of 1 cup (170ml) per hour, whilst waiting in hospital for an elective CD planned under neuraxial anaesthesia. Prior to their CD, any remaining drink will be weighed to calculate to volume consumed (assuming a liquid density of 1mg/ml)

  • The "water group"

    Drug

    women will be provided with a weighed jug of water which the participants may sip to comfort at a maximum rate of 1 cup (170ml) per hour

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: 'Sip Til Send' with waterOther 1 intervention
Group B: 'Sip Til Send' with carbohydrate-rich drinksActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

24-hour Obstetric Quality of Recovery-10 (ObsQoR-10) scores

Compare the 24-hour quality of recovery scores : At around 24 hours after delivery (+/- 4 hours), women will be approached for a single follow-up visit where they will be asked to complete an obstetric-specific quality of recovery score (ObsQoR-10). This is scale from 0 to 100, with a higher number indicating a better quality of recovery.

Time frame
From enrollment to around 24 hours after delivery (+/- 4 hours).
2

Gastric antrum CSA

Compare the gastric antrum CSA immediately prior to caesarean delivery: 'fasting' gastric ultrasound will be performed in a standardised manner prior to randomization, Prior to their CD, participants will undergo a second gastric ultrasound scan immediately prior to surgery.

Time frame
From enrollment until just before their cesarean delivery.

Secondary outcomes

1

Estimated residual gastric volume before CD

Compare the estimated residual gastric volumes prior to caesarean delivery : Gastric antrum CSA will be calculated using horizontal and vertical calliper measurements inputted into a formula to calculate the area of an ellipse. These will also be used to estimate gastric volumes via the method below that has been validated in term pregnant women previously: GV (mL) = 0.18 x right-lateral CSA (mm2) + 0.11 x semirecumbent CSA (mm2) - 62.4

Time frame
From enrollment until just before their cesarean delivery.
2

Incidence of a full stomach assessed by quantitative ultrasound measurements

Compare the incidence of estimated residual gastric volumes \>1.5ml/kg

Time frame
From enrollment until just before their cesarean delivery.
3

Qualitative ultrasound guided incidence of a full stomach

Compare the incidence of Perlas 2 scores : A qualitative Perlas score is given based on whether clear liquid is seen in the antrum in each position. A Perlas 0 antrum has no fluid in either position, a Perlas 1 has clear fluid in the right-lateral position but not when semi-recumbent and a Perlas 2 score has identifiable clear fluid in both positions

Time frame
From enrollment until just before their cesarean delivery.
4

Compare the maternal urinary ketones during caesarean delivery

During surgery, a urinary catheter is inserted as part of standard clinical care. A urine sample will be collected from this prior to delivery and sent to the lab to test for ketones.

Time frame
From enrollment until just before their cesarean delivery.

Other outcomes

Sponsors and contacts

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