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Colloid Preload Versus Colloid Coload During Cesarean Deliveries

NCT ID: NCT02393196

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Spinal anesthesia (SA) is currently the most preferred method of anesthesia in elective cesarean deliveries. However, SA causes maternal hypotension by decreasing systemic vascular resistance over sympathetic blockade. Maternal hypotension can lead to serious adverse events both in mother and in fetus: fetal hypoxia and acidosis occur due to decreased uterine blood flow, whereas the mother may experience vertigo, nausea, vomiting, alteration in consciousness, cardiovascular collapse and arrest. Today, various strategies have been suggested for the prevention of maternal hypotension. Of these strategies, the most critical ones are fluid load before spinal anesthesia (preloading) or rapid fluid load just after spinal anesthesia (coloading) and the use of vasopressor agent. The fluids used for this purpose include crystalloids and colloids. Comparative studies performed with colloid preloading, colloid coloading and crystalloid coloading indicated that the incidence of hypotension decreased similarly with no significant difference determined between the methods of fluid loading. Researchers defended necessity of using vasopressor agent together with fluid loading methods. In daily routine; however, the investigators observe that the incidence of hypotension is lower in the patients that undergo colloid preloading as compared to the patients that undergo colloid coloading or crystalloid coloading. The investigators therefore aimed to compare the methods colloid preloading and colloid coloading in terms of the incidence of maternal hypotension and impacts on neonatal outcomes. In the present study, the investigators aimed to use 6% HES 130/0.4 (Voluven ®), which is the newer generation colloid solution. The other 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.

Conditions

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Anesthesia; Adverse Effect, Spinal and Epidural Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group Preloading (Group P)

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Before spinal anesthesia

Group Coloading (Group C)

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Just after spinal anesthesia

Interventions

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

Before spinal anesthesia

Intervention Type DRUG

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

Just after spinal anesthesia

Intervention Type DRUG

Other Intervention Names

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(Voluven®; Fresenius Kabi, Bad Homburg, Germany) (Voluven®; Fresenius Kabi, Bad Homburg, Germany)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sifa University

OTHER

Sponsor Role lead

Responsible Party

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Aysun Afife Kar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysun Afife Kar, MD

Role: PRINCIPAL_INVESTIGATOR

Şifa Üniversitesi, Basmane Hastanesi, İzmir, Turkey

Locations

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Şifa Üniversitesi, Basmane Hastanesi

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Aysun Afife Kar, MD

Role: CONTACT

[email protected]
+905326521313

Other Identifiers

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SifaU

Identifier Type: -

Identifier Source: org_study_id