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Hypotensionannie-manosNCT04406051

Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.

A study testing norepinephrine infusion and colloid preloading (NOR-COL) and norepinephrine infusion and crystalloid co-loading (NOR-CRYST) in people with Hypotension and Obstetric Anesthesia Problems, run by Aretaieion University Hospital at 2 sites in Greece.

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

This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section Read more about this study

Who is it for?
Ages 18 to 48 years, women only
What is being tested?
norepinephrine infusion and colloid preloading (NOR-COL) and norepinephrine infusion and crystalloid co-loading (NOR-CRYST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesGreece
Study dates
26 May 2020to 30 Apr 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 48 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • adult parturients, American Society of Anesthesiologists (ASA) I-II,
  • singleton gestation>37 weeks
  • elective cesarean section

Who cannot join

  • Body Mass Index (BMI) >40 kg/m2
  • Body weight <50 kg
  • Body weight>100 kg
  • height<150 cm
  • height>180 cm
  • multiple gestation
Show all 17Show fewer
  • fetal abnormality
  • fetal distress
  • active labor
  • cardiac disease
  • pregnancy-induced hypertension
  • thrombocytopenia
  • coagulation abnormalities
  • use of antihypertensive medication during pregnancy
  • communication or language barriers
  • lack of informed consent
  • contraindication for regional anesthesia

Trial locations and contacts

2 sites in 1 country.

Greece2 sites

  • Aretaieion University Hospital

    Athens, 115 28

  • Alexandra General Hospital of Athens

    Athens, 11528

Other trials in Greece

About this study

Official title: Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion. Does Time and Type of Administered Fluids Matter?

This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section

Read the detailed description

Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.

The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section.

Being tested
norepinephrine infusion and colloid preloading (NOR-COL), norepinephrine infusion and crystalloid co-loading (NOR-CRYST)
Medical subject headings
Hypotension

What participants receive

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

  • norepinephrine infusion and colloid preloading (NOR-COL)Procedure or surgery

    in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia

  • norepinephrine infusion and crystalloid co-loading (NOR-CRYST)Procedure or surgery

    in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia

Study groups in NCT04406051
Study groupRoleWhat they receive
norepinephrine infusion and colloid preloading (NOR-COL)Active comparatorin parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)
Receives: Procedure: norepinephrine infusion and colloid preloading (NOR-COL)
norepinephrine infusion and crystalloid co-loading (NOR-CRYS)Active comparatorin parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg)
Receives: Procedure: norepinephrine infusion and crystalloid co-loading (NOR-CRYST)

What is being measured

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

  1. incidence of hypotension

    any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded

    Measured: intraoperative

Secondary outcomes (12)

  1. need for vasoconstrictor

    any need for vasoconstrictor during the operation will be recorded

    Measured: intraoperative

  2. type of vasoconstrictor administered

    phenylephrine versus ephedrine

    Measured: intraoperative

  3. total dose of vasoconstrictor administered

    total dose in mg for ephedrine or μg for phenylephrine administered

    Measured: intraoperative

  4. incidence of hypertension

    any incidence of systolic blood pressure>120% of baseline will be recorded

    Measured: intraoperative

  5. incidence of bradycardia

    any incidence of maternal bradycardia (heart rate<60/min) will be recorded

    Measured: intraoperative

  6. need for atropine

    any need for atropine during the operation because of bradycardia will be recorded

    Measured: intraoperative

  7. modification or cessation of the infusion

    any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded

    Measured: intraoperative

  8. incidence of nausea/vomiting

    any occurence of nausea and/or vomiting during the operation will be recorded

    Measured: intraoperative

  9. Neonatal Apgar score at 1 min

    Neonatal Apgar score will be recorded at 1 min after delivery. 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. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.

    Measured: 1 min post delivery

  10. Neonatal Apgar score at 5 min

    Neonatal Apgar score will be recorded at 5 min after delivery. 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. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.

    Measured: 5 min post delivery

  11. neonatal blood gases

    fetal cord blood analysis will be performed immediately post-delivery

    Measured: 1 min post delivery

  12. glucose in neonatal blood

    glucose will be measured in the cord blood gas sample taken immediately post-delivery

    Measured: 1 min post delivery

Timeline

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

  1. First posted28 May 2020
  2. Study start26 May 2020
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04406051
Sponsor's protocol ID
nor-cryst vs. nor-coll
Acronym
annie-manos
Status last verified
Jun 2021
First submitted
24 May 2020
Last updated
15 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.

    PubMed 23076903

  • Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.

    PubMed 20455872

  • Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6.

    PubMed 20173633

  • 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

  • Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.

    PubMed 19859776

  • Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. No abstract available.

    PubMed 21948275

  • Li L, Zhang Y, Tan Y, Xu S. Colloid or crystalloid solution on maternal and neonatal hemodynamics for cesarean section: a meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2013 May;39(5):932-41. doi: 10.1111/jog.12001. Epub 2013 Feb 4.

    PubMed 23379937

Questions about this trial

What is this clinical trial studying?

A study testing norepinephrine infusion and colloid preloading (NOR-COL) and norepinephrine infusion and crystalloid co-loading (NOR-CRYST) in people with Hypotension and Obstetric Anesthesia Problems, run by Aretaieion University Hospital at 2 sites in Greece.

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 17 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. 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 hypotension (time frame: intraoperative). 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 NCT04406051, which also lists 7 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 15 Jun 2021.

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