NCT02393196

Brief Summary

The investigators aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. The second aim while planning the present study is to identify the method of the lowest adverse event for mother and infant and the simplest approach for the clinician.

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
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4

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

March 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

March 1, 2015

Last Update Submit

November 16, 2015

Conditions

Anesthesia; Adverse Effect, Spinal and EpiduralHypotension

Keywords

colloid preloadingcolloid coloading

Outcome Measures

Primary Outcomes (4)

  • Maternal hypotension.

    Maternal hypotension will be defined as at least a single administration of ephedrine within the period from induction of SA to the delivery (umbilical cord clamping). After spinal anesthesia, SAP will be measured and recorded at every minute until birth and every three minutes thereafter.

    Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.

  • Incidence of severe hypotension.

    Incidence of severe hypotension (SAP \< 70% of the baseline value or SAP \< 80 mmHg) will be recorded.

    Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.

  • Cumulative duration of hypotension.

    Cumulative duration of hypotension will be recorded from induction of spinal anesthesia until delivery (umbilical cord clamping).

    Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.

  • Heart rate.

    Minimum and maximum heart rate, bradycardia, atropine usage will be recorded.

    Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.

Secondary Outcomes (3)

  • Neonatal effects.

    Time just after delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.

  • Ephedrine treatment.

    Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.

  • Nausea and/or vomiting.

    Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.

Other Outcomes (3)

  • Preoperative fasting period.

    Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.

  • Preoperative hemoglobin concentration (g/dL).

    Time before spinal anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.

  • Durations of anesthesia and surgery.

    Time between induction of spinal anesthesia until end of the anesthesia. Participants will be followed for the duration of hospital stay, an expected average of two days.

Study Arms (2)

Group Preloading (Group P)

ACTIVE COMPARATOR

Group Preloading (Group P): 500 mL hydroxyethyl starch (6% HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible before spinal anesthesia.

Drug: hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)

Group Coloading (Group C)

ACTIVE COMPARATOR

Group Coloading (Group C): After the patients have been monitored, spinal anesthesia will be performed. Recognizing the cerebrospinal fluid, 500 mL hydroxyethyl starch (%6 HES 130/0.4) (Voluven®; Fresenius Kabi, Bad Homburg, Germany) will be infused via a pressure infusion system at a maximum speed as possible.

Drug: hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)

Interventions

hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)DRUG

Just after spinal anesthesia

Also known as: (Voluven®; Fresenius Kabi, Bad Homburg, Germany)
Group Coloading (Group C)

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Singleton pregnancy
  • Gestational age ≥ 37 weeks
  • Height ≥ 150 cm and ≤ 180 cm
  • Weight \> 50 kg and \< 100 kg

You may not qualify if:

  • Gestational age \> 37 weeks
  • Multiple pregnancies
  • Fetal distress
  • Preeclampsia
  • Cardiovascular disease and diabetes
  • Hematological problems
  • Local infection at intervention site
  • Abnormal coagulation tests
  • Anticoagulant use
  • Starch allergy
  • Height \< 150 cm and \> 180 cm
  • Weight \< 50 kg and \> 100 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şifa Üniversitesi, Basmane Hastanesi

Izmir, 35100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Hydroxyethyl Starch DerivativesHES 130-0.4

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Aysun Afife Kar, MD

    Şifa Üniversitesi, Basmane Hastanesi, İzmir, Turkey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aysun Afife Kar, MD

CONTACT

+905326521313aaysunkar@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 1, 2015

First Posted

March 19, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

TU(1)