Clinical trial NCT02622126: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coagulation Defect; Bleeding
Keywords: Preloading
Colloid
Cesarean section
D-dimer
Hypotension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Coagulation defect (detection of D-Dimer) of the mother
timeFrame: Pre and post cesarean delivery, an expected average of 90 minutes
measure: Coagulation defect (detection of D-Dimer) of the baby
timeFrame: Pre and post cesarean delivery, an expected average of 90 minutes
Secondary outcomes:
measure: Maternal hypotension (fall of > 20% of MAP (mm Hg ) from baseline)
timeFrame: Post spinal for cesarean delivery, an expected average of 4 hours
measure: Ephedrine treatment (Ephedrine total dosage (mg))
timeFrame: Post spinal for cesarean delivery, an expected average of 4 hours
measure: Atropine treatment (atropine total dosage (mg))
timeFrame: Post spinal for cesarean delivery, an expected average of 4 hours
measure: Hemoglobin concentration
timeFrame: Pre and post cesarean delivery, an expected average of 4 hours
measure: Platelet count
timeFrame: Pre and post cesarean delivery, an expected average of 4 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor
name: sayed abd elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References: