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

Study Overview
=================
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).

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

Conditions
-----------------
Coagulation Defect; Bleeding

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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normotensive pregnant women group<br>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)<br>* preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).<br>* Other names: Voluven;Drug: Hyperbaric bupivacaine<br>* Sub arachnoid 10-12 mg hyperbaric bupivacaine<br>* Other names: Marcaine;Drug: Morphine<br>* Sub arachnoid 200 meg morphine<br>Drug: Isotonic 0.9 sodium chloride (NaCl) solution<br>* 10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation<br>* Other names: Normal saline;Drug: Ephedrine<br>* If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.<br>Drug: Atropine<br>* 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.<br>|
| Active Comparator: Mild preeclampsia pregnant women group<br>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)<br>* preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).<br>* Other names: Voluven;Drug: Hyperbaric bupivacaine<br>* Sub arachnoid 10-12 mg hyperbaric bupivacaine<br>* Other names: Marcaine;Drug: Morphine<br>* Sub arachnoid 200 meg morphine<br>Drug: Isotonic 0.9 sodium chloride (NaCl) solution<br>* 10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation<br>* Other names: Normal saline;Drug: Ephedrine<br>* If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.<br>Drug: Atropine<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline) | 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)) | Ephedrine total dosage (mg) | Post spinal for cesarean delivery, an expected average of 4 hours | 
| Atropine treatment (atropine total dosage (mg)) | atropine total dosage (mg) | Post spinal for cesarean delivery, an expected average of 4 hours | 
| Hemoglobin concentration | Blood samples for detection of hemoglobin concentration gm/dL | Pre and post cesarean delivery, an expected average of 4 hours | 
| Platelet count | Blood samples for detection of platelet count (109/L ) | Pre and post cesarean delivery, an expected average of 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preloading, Colloid, Cesarean section, D-dimer, Hypotension