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

Primary Purpose

Coagulation Defect; Bleeding

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
hydroxyethyl starch (6% 130/0.4)
Hyperbaric bupivacaine
Morphine
Isotonic 0.9 sodium chloride (NaCl) solution
Ephedrine
Atropine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coagulation Defect; Bleeding focused on measuring Preloading, Colloid, Cesarean section, D-dimer, Hypotension

Eligibility Criteria

19 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Height < 150 cm and > 180 cm
  • Weight < 50 kg and > 100 kg
  • Patient refusing spinal anesthesia
  • Fetal anomalies
  • Fetal distress or cases with umbilical cord prolapsed

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Normotensive pregnant women group

Mild preeclampsia pregnant women group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline)
fall of > 20% of MAP (mm Hg ) from baseline
Ephedrine treatment (Ephedrine total dosage (mg))
Ephedrine total dosage (mg)
Atropine treatment (atropine total dosage (mg))
atropine total dosage (mg)
Hemoglobin concentration
Blood samples for detection of hemoglobin concentration gm/dL
Platelet count
Blood samples for detection of platelet count (109/L )

Full Information

First Posted
December 1, 2015
Last Updated
November 4, 2016
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02622126
Brief Title
Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia
Official Title
The Effects of Colloid Pre-Loading on D-Dimer of the Mother and Her Baby During Cesarean Section Under Spinal Anesthesia for Mild Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The patients were divided into two equal group of thirty patients in each group; Control group (normotensive pregnant women) and Mild preeclampsia group. In both groups patients preloaded with 500 mL hydroxyethyl starch (HES) 6% (130/0.4) (Voluven). Spinal anesthesia will be performed with intrathecal 10-12 mg hyperbaric bupivacaine in addition to 200 meg morphine. The patient was placed supine with left lateral tilt to alleviate aortocaval compression. 10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used co loading during the duration of the operation. Blood pressure was measured and recorded every three minutes. If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used. The blood pressure will rechecked 1 minute after each doses of ephedrine. If hypotension persisted after 30 mg of ephedrine, an additional 2 ml/kg of isotonic 0.9 NaCl solutions will be infused rapidly. Maternal hypotension is defined as at least a single administration of ephedrine within the period from induction of spinal anesthesia until transfer to postoperative recovery unit. Reactive hypertension is characterized as a blood pressure 20% greater than baseline mean levels after the use of the vasopressor. Bradycardia is defined as a fall of >30% of heart rate from baseline or <50 beats /minute. Bradycardia, and when associated with hypotension it will be treated with 0.5 mg of atropine intravenous. Upon completion of the cesarean section, the subject will be transported to the postanesthesia care unit (PACU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulation Defect; Bleeding
Keywords
Preloading, Colloid, Cesarean section, D-dimer, Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normotensive pregnant women group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Mild preeclampsia pregnant women group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
hydroxyethyl starch (6% 130/0.4)
Other Intervention Name(s)
Voluven
Intervention Description
preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).
Intervention Type
Drug
Intervention Name(s)
Hyperbaric bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Sub arachnoid 10-12 mg hyperbaric bupivacaine
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Sub arachnoid 200 meg morphine
Intervention Type
Drug
Intervention Name(s)
Isotonic 0.9 sodium chloride (NaCl) solution
Other Intervention Name(s)
Normal saline
Intervention Description
10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation
Intervention Type
Drug
Intervention Name(s)
Ephedrine
Intervention Description
If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Coagulation defect (detection of D-Dimer) of the mother
Description
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
Time Frame
Pre and post cesarean delivery, an expected average of 90 minutes
Title
Coagulation defect (detection of D-Dimer) of the baby
Description
Blood sample for detection of D-Dimer was taken from the umbilical cord of the fetus before clamping
Time Frame
Pre and post cesarean delivery, an expected average of 90 minutes
Secondary Outcome Measure Information:
Title
Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline)
Description
fall of > 20% of MAP (mm Hg ) from baseline
Time Frame
Post spinal for cesarean delivery, an expected average of 4 hours
Title
Ephedrine treatment (Ephedrine total dosage (mg))
Description
Ephedrine total dosage (mg)
Time Frame
Post spinal for cesarean delivery, an expected average of 4 hours
Title
Atropine treatment (atropine total dosage (mg))
Description
atropine total dosage (mg)
Time Frame
Post spinal for cesarean delivery, an expected average of 4 hours
Title
Hemoglobin concentration
Description
Blood samples for detection of hemoglobin concentration gm/dL
Time Frame
Pre and post cesarean delivery, an expected average of 4 hours
Title
Platelet count
Description
Blood samples for detection of platelet count (109/L )
Time Frame
Pre and post cesarean delivery, an expected average of 4 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Height < 150 cm and > 180 cm Weight < 50 kg and > 100 kg Patient refusing spinal anesthesia Fetal anomalies Fetal distress or cases with umbilical cord prolapsed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sayed abd elshafy, MD
Organizational Affiliation
associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt

12. IPD Sharing Statement

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

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