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

Coagulation Defect; Bleeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622126
• Other study ID #: IRB0000871175
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2015
• Last updated: November 4, 2016
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Defect; Bleeding
• Hemostatic Disorders

Intervention

Drug:
• hydroxyethyl starch (6% 130/0.4)
preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).
• Hyperbaric bupivacaine
Sub arachnoid 10-12 mg hyperbaric bupivacaine
• Morphine
Sub arachnoid 200 meg morphine
• Isotonic 0.9 sodium chloride (NaCl) solution
10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation
• Ephedrine
If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.
• Atropine
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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	Ephedrine treatment (Ephedrine total dosage (mg))	Ephedrine total dosage (mg)	Post spinal for cesarean delivery, an expected average of 4 hours	Yes
Secondary	Atropine treatment (atropine total dosage (mg))	atropine total dosage (mg)	Post spinal for cesarean delivery, an expected average of 4 hours	Yes
Secondary	Hemoglobin concentration	Blood samples for detection of hemoglobin concentration gm/dL	Pre and post cesarean delivery, an expected average of 4 hours	Yes
Secondary	Platelet count	Blood samples for detection of platelet count (109/L )	Pre and post cesarean delivery, an expected average of 4 hours	Yes