NCT02622126

The Effects of Colloid Pre-Loading on D-Dimer of the Mother and Her Baby During Cesarean Section Under Spinal Anesthesia for Mild Preeclampsia

Completed Phase 2 Last updated 4 November 2016

What this trial tests

Phase 2 trial testing hydroxyethyl starch (6% 130/0.4) in Coagulation Defect; Bleeding in 60 participants. Completed in 1 July 2016.

Timeline

1 January 2016

Primary endpoint
1 July 2016

1 July 2016

Quick facts

Lead sponsor	Assiut University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	1 January 2016
Primary completion	1 July 2016
Estimated completion	1 July 2016
Sites	1 location across Egypt

Drugs / interventions tested

• hydroxyethyl starch (6% 130/0.4) — full drug profile →
• Hyperbaric bupivacaine — full drug profile →
• Morphine
• Isotonic 0.9 sodium chloride (NaCl) solution — full drug profile →
• Ephedrine (EPHEDRINE) — full drug profile →
• Atropine (ATROPINE) — full drug profile →

Conditions studied

• Coagulation Defect; Bleeding — all drugs for Coagulation Defect; Bleeding →

Sponsor

Assiut University

Who can join

Adults 19 to 50, female only, with Coagulation Defect; Bleeding. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.