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PregnancyNCT03729076

Crystalloid Versus Colloid Rapid Co-load for Cesarean Delivery Under Spinal Anesthesia

A study testing Crystalloid and Colloid in people with Pregnancy and Cesarean Delivery, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study aims to compare crystalloid co-loading and colloid co-loading in parturients receiving prophylactic phenylephrine infusion during cesarean delivery in terms of the incidence of hypotension. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Pregnancy, Cesarean Delivery, Hypotension
What is being tested?
Crystalloid and Colloid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSouth Korea
Study dates
16 Nov 2018to 12 Jan 2020
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 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Healthy, full-term parturients who scheduled to undergo elective cesarean delivery under spinal anesthesia.

Who cannot join

  • multiple pregnancy
  • gestational age < 36 weeks
  • preexisting or pregnancy-induced hypertension
  • Morbid cardiovascular impairments
  • Cerebrovascular disease
  • ⑥ Known fetal anomaly
Show all 10Show fewer
  • ⑦ Contraindications to spinal anesthesia
  • ⑧ Any sign of onset of labor
  • ⑨ Body weight < 45 kg or body weight > 90 kg
  • ⑩ Height < 145cm or height > 180cm

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Crystalloid Versus Colloid Rapid Co-load in Parturients Receiving Prophylactic Phenylephrine Infusion During Cesarean Delivery Under Spinal Anesthesia

The study aims to compare crystalloid co-loading and colloid co-loading in parturients receiving prophylactic phenylephrine infusion during cesarean delivery in terms of the incidence of hypotension.

Being tested
Crystalloid, Colloid
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CrystalloidOther

    Patients will receive the rapid co-loading with plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.

  • ColloidOther

    Patients will receive the rapid co-loading with 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.

Study groups in NCT03729076
Study groupRoleWhat they receive
CrystalloidExperimentalPatients will receive rapid co-load of plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia.
Receives: Other: Crystalloid
ColloidActive comparatorPatients will receive rapid co-load of 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia.
Receives: Other: Colloid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of maternal hypotension

    defined as: Systolic Blood Pressure (SBP) < 80% of baseline SBP

    Measured: during the time period from induction of spinal anesthesia until delivery

Secondary outcomes (20)

  1. incidence of severe hypotension

    defined as: Systolic Blood Pressure (SBP) < 70% of baseline SBP

    Measured: during the time period from induction of spinal anesthesia until delivery

  2. incidence of symptomatic hypotension

    defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness

    Measured: during the time period from induction of spinal anesthesia until delivery

  3. incidence of bradycardia

    Heart Rate (HR) <50 bpm

    Measured: during the time period from induction of spinal anesthesia until delivery

  4. incidence of Hypertension

    Systolic Blood Pressure (SBP)> 120% of baseline SBP

    Measured: during the time period from induction of spinal anesthesia until delivery

  5. Minimum recorded Systolic Blood Pressure (Minimum SBP)

    The lowest recorded SBP during the time period from induction of spinal anesthesia until delivery

    Measured: during the time period from induction of spinal anesthesia until delivery

  6. Minimum recorded Heart Rate (Minimum HR)

    The lowest recorded HR during the time period from induction of spinal anesthesia until delivery

    Measured: during the time period from induction of spinal anesthesia until delivery

  7. Cumulative duration of hypotension

    duration of hypotension, minutes

    Measured: during the time period from induction of spinal anesthesia until delivery

  8. Onset time of hypotension

    Time from the induction of spinal anesthesia until the first event of hypotension occur

    Measured: during the time period from induction of spinal anesthesia until delivery

  9. Total phenylephrine use

    Cumulative dose of phenylephrine administered via continuous infusion, mcg

    Measured: during the time period from induction of spinal anesthesia until delivery

  10. Rescue phenylephrine use

    number of patients who require the rescue use of phenylephrine

    Measured: during the time period from induction of spinal anesthesia until delivery

  11. Rescue ephedrine use

    number of patients who require the rescue use of ephedrine

    Measured: during the time period from induction of spinal anesthesia until delivery

  12. Atropine use

    number of patients who require the rescue use of atropine

    Measured: during the time period from induction of spinal anesthesia until delivery

  13. Incidence of nausea, vomiting

    The incidence of nausea, vomiting

    Measured: during the time period from induction of spinal anesthesia until delivery

  14. Incidence of dizziness, breathlessness

    The incidence of dizziness, breathlessness

    Measured: during the time period from induction of spinal anesthesia until delivery

  15. Cutaneous stellate ganglion sympathetic activity

    noninvasive recording of skin sympathetic nerve activity (SKNA) using conventional ECG electrodes

    Measured: during the time period from induction of spinal anesthesia until delivery

  16. Apgar Score, 1 min, 5 min (fetal outcome)

    Apgar Score of delivered baby. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are the Appearance, Pulse, Grimace, Activity, and Respiration. Each is scored on a scale of 0 to 2, with 2 being the best score. The test is done at 1 and 5 minutes after birth.

    Measured: 1 min, 5 min after delivery

  17. Umbilical arterial pH

    pH of Umbilical Arterial blood gas analysis (ABGA) (fetal outcome)

    Measured: immediately after delivery

  18. Umbilical arterial base excess

    base excess of Umbilical ABGA (fetal outcome), mmol/L

    Measured: immediately after delivery

  19. Umbilical arterial partial oxygen pressure (PO2)

    partial oxygen pressure of Umbilical ABGA (fetal outcome), mmHg

    Measured: immediately after delivery

  20. Umbilical arterial carbon dioxide partial pressure (PCO2)

    carbon dioxide partial pressure of Umbilical ABGA (fetal outcome), mmHg

    Measured: immediately after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start16 Nov 2018
  3. Primary completion8 Jan 2020
  4. Study completion12 Jan 2020

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03729076
Sponsor's protocol ID
H-1807-152-961
Status last verified
Jan 2020
First submitted
28 Oct 2018
Last updated
5 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

    PubMed 29090733

  • Ripolles Melchor J, Espinosa A, Martinez Hurtado E, Casans Frances R, Navarro Perez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11.

    PubMed 25501602

  • Tawfik MM, Tarbay AI, Elaidy AM, Awad KA, Ezz HM, Tolba MA. Combined Colloid Preload and Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2019 Feb;128(2):304-312. doi: 10.1213/ANE.0000000000003306.

    PubMed 29461392

  • Doytchinova A, Hassel JL, Yuan Y, Lin H, Yin D, Adams D, Straka S, Wright K, Smith K, Wagner D, Shen C, Salanova V, Meshberger C, Chen LS, Kincaid JC, Coffey AC, Wu G, Li Y, Kovacs RJ, Everett TH 4th, Victor R, Cha YM, Lin SF, Chen PS. Simultaneous noninvasive recording of skin sympathetic nerve activity and electrocardiogram. Heart Rhythm. 2017 Jan;14(1):25-33. doi: 10.1016/j.hrthm.2016.09.019. Epub 2016 Sep 23.

    PubMed 27670627

Questions about this trial

What is this clinical trial studying?

A study testing Crystalloid and Colloid in people with Pregnancy and Cesarean Delivery, run by Seoul National University Hospital at 1 site in South Korea.

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 10 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 5 Feb 2020. 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 South Korea. 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?

Incidence of maternal hypotension (time frame: during the time period from induction of spinal anesthesia until delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03729076, which also lists 4 linked publications.

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 5 Feb 2020; AzTrials last refreshed its copy on 1 Nov 2026.

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