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NCT Number: NCT02622126

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

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.

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Key information

Age range

19 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydroxyethyl starch (6% 130/0.4)

Drug

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

Other names: Voluven

Hyperbaric bupivacaine

Drug

Sub arachnoid 10-12 mg hyperbaric bupivacaine

Other names: Marcaine

Morphine

Drug

Sub arachnoid 200 meg morphine

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

Other names: Normal saline

Ephedrine

Drug

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

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.

Primary outcomes

  1. Coagulation defect (detection of D-Dimer) of the mother

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

    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

  2. Coagulation defect (detection of D-Dimer) of the baby

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

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

Secondary outcomes

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

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

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

  2. Ephedrine treatment (Ephedrine total dosage (mg))

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

    Ephedrine total dosage (mg)

  3. Atropine treatment (atropine total dosage (mg))

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

    atropine total dosage (mg)

  4. Hemoglobin concentration

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

    Blood samples for detection of hemoglobin concentration gm/dL

  5. Platelet count

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

    Blood samples for detection of platelet count (109/L )

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Nov 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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