Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia

NCT02622126 | Completed Phase 2 DMC

• 1 other identifier: IRB0000871175
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal hypotension is the most frequent complication of a spinal Anesthesia. The prevention of spinal hypotension appears more likely to decrease the frequency and severity of associated adverse maternal symptoms than the treatment of established hypotension. Intravenous fluid administration prior to spinal anesthesia for caesarean section is accepted standard practice. The choice of fluid depends on individual and institutional habit, material cost (crystalloid is considerably cheaper) and the perceived relative benefits and risks. Uncommon but potentially serious adverse effect of colloids is impaired coagulation. Although pregnancy is associated with hypercoagulability, little is known about the effects of colloid preloading on coagulation in pregnant patients.

Conditions

Coagulation Defect; Bleeding

Keywords

Preloading; Colloid; Cesarean section; D-dimer; Hypotension

Outcome Measures

Primary Outcomes (2)

• Coagulation defect (detection of D-Dimer) of the mother

  Blood samples for detection of D-Dimer were taken from the mother preoperatively (before colloid administration) and another one at the end of the operation

  Pre and post cesarean delivery, an expected average of 90 minutes

• Coagulation defect (detection of D-Dimer) of the baby

  Blood sample for detection of D-Dimer was taken from the umbilical cord of the fetus before clamping

  Pre and post cesarean delivery, an expected average of 90 minutes

Secondary Outcomes (5)

• Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline)

  Post spinal for cesarean delivery, an expected average of 4 hours

• Ephedrine treatment (Ephedrine total dosage (mg))

  Post spinal for cesarean delivery, an expected average of 4 hours

• Atropine treatment (atropine total dosage (mg))

  Post spinal for cesarean delivery, an expected average of 4 hours

• Hemoglobin concentration

  Pre and post cesarean delivery, an expected average of 4 hours

• Platelet count

  Pre and post cesarean delivery, an expected average of 4 hours

Study Arms (2)

Normotensive pregnant women group

ACTIVE COMPARATOR

Preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6% 130/0.4) (Voluven). Sub arachnoid 10-12 mg hyperbaric bupivacaine Sub arachnoid 200 meg morphine Isotonic 0.9 sodium chloride (NaCl) solution ( 10 ml/kg) will be used as co loading during the duration of the operation Ephedrine 6 me intravenous will be used to treat severe hypotension (fall of \> 20% of mean arterial pressure from baseline) Atropine 0.5 mg intravenous will be used to treat bradycardia (fall of \>30% of heart rate from baseline or \<50 beats /minute and when associated with hypotension)

Drug: hydroxyethyl starch (6% 130/0.4); Drug: Hyperbaric bupivacaine; Drug: Morphine; Drug: Isotonic 0.9 sodium chloride (NaCl) solution; Drug: Ephedrine; Drug: Atropine

Mild preeclampsia pregnant women group

ACTIVE COMPARATOR

Preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6% 130/0.4) (Voluven). Sub arachnoid 10-12 mg hyperbaric bupivacaine Sub arachnoid 200 meg morphine Isotonic 0.9 sodium chloride (NaCl) solution (NaCl) solution ( 10 ml/kg) will be used as co loading during the duration of the operation Ephedrine 6 me intravenous will be used to treat severe hypotension (fall of \> 20% of mean arterial pressure from baseline) Atropine 0.5 mg intravenous will be used to treat bradycardia (fall of \>30% of heart rate from baseline or \<50 beats /minute and when associated with hypotension)

Drug: hydroxyethyl starch (6% 130/0.4); Drug: Hyperbaric bupivacaine; Drug: Morphine; Drug: Isotonic 0.9 sodium chloride (NaCl) solution; Drug: Ephedrine; Drug: Atropine

Interventions

hydroxyethyl starch (6% 130/0.4) DRUG

preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).

Also known as: Voluven

Mild preeclampsia pregnant women group; Normotensive pregnant women group

Hyperbaric bupivacaine DRUG

Sub arachnoid 10-12 mg hyperbaric bupivacaine

Also known as: Marcaine

Mild preeclampsia pregnant women group; Normotensive pregnant women group

Morphine DRUG

Sub arachnoid 200 meg morphine

Mild preeclampsia pregnant women group; Normotensive pregnant women group

Isotonic 0.9 sodium chloride (NaCl) solution DRUG

10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation

Also known as: Normal saline

Mild preeclampsia pregnant women group; Normotensive pregnant women group

Ephedrine DRUG

If severe hypotension (fall of \> 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.

Mild preeclampsia pregnant women group; Normotensive pregnant women group

Atropine DRUG

Bradycardia (fall of \>30% of heart rate from baseline or \<50 beats /minute and when associated with hypotension) will treated with 0.5 mg of atropine intravenous.

Mild preeclampsia pregnant women group; Normotensive pregnant women group

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologist (ASA) status I or II
• Aged \>18 years
• Singleton pregnancy
• Gestational age ≥ 37 weeks
• Height ≥ 150 cm and ≤ 180 cm
• Weight \> 50 kg and \< 100 kg
• Eligible for spinal anesthesia
• Elective cesarean delivery

You may not qualify if:

• Multiple pregnancies
• Cardiovascular disease cerebrovascular disease
• Diabetes Mellitus
• Hematological problems
• Abnormal coagulation tests
• Anticoagulant use
• Hemorrhagic syndromes of pregnancy (placenta previa or accidental hemorrhage)
• Regular NSAIDS treatment
• HELLP syndrome
• Severe preeclampsia
• Eclampsia
• Termination of pregnancy for any cause
• Peripheral neuropathy or chronic pain syndrome
• Local infection or injury at the needle entry point
• Known hypersensitivity reaction to local anesthetic, starch allergy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Conditions

Hemostatic Disorders; Hemorrhage; Hypotension

Interventions

Hydroxyethyl Starch Derivatives; HES 130-0.4; Bupivacaine; Morphine; Solutions; Saline Solution; Ephedrine; Atropine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Propanolamines; Amino Alcohols; Alcohols; Propanols; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic

Study Officials

• sayed abd elshafy, MD

  associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 4, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

EG (1)