Colloid Preload Versus Colloid Coload During Cesarean Deliveries

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02393196
• Date of registration: 01/03/2015
• Prospective Registration: Yes
• Primary sponsor: Sifa University
• Public title: Colloid Preload Versus Colloid Coload During Cesarean Deliveries
• Scientific title: Colloid Preload Versus Colloid Coload in Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Section Deliveries: A Prospective, Randomized, Double-Blind Comparative Study
• Date of first enrolment: March 2015
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02393196
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Aysun Afife Kar, MD

• Name: Aysun Afife Kar, MD
• Affiliation: Sifa Üniversitesi, Basmane Hastanesi, Izmir, Turkey

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 18 years or older

- Singleton pregnancy

- Gestational age = 37 weeks

- Height = 150 cm and = 180 cm

- Weight > 50 kg and < 100 kg

Exclusion Criteria:

- Gestational age > 37 weeks

- Multiple pregnancies

- Fetal distress

- Preeclampsia

- Cardiovascular disease and diabetes

- Hematological problems

- Local infection at intervention site

- Abnormal coagulation tests

- Anticoagulant use

- Starch allergy

- Height < 150 cm and > 180 cm

- Weight < 50 kg and > 100 kg



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Hypotension

Anesthesia; Adverse Effect, Spinal and Epidural

Intervention(s)

Drug: hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)

Drug: hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)

Primary Outcome(s)

Cumulative duration of hypotension. [Time Frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.]

Incidence of severe hypotension. [Time Frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.]

Heart rate. [Time Frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.]

Maternal hypotension. [Time Frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.]

Secondary Outcome(s)

Nausea and/or vomiting. [Time Frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.]

Neonatal effects. [Time Frame: Time just after delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.]

Ephedrine treatment. [Time Frame: Time between induction of spinal anesthesia until delivery (umbilical cord clamping). Participants will be followed for the duration of hospital stay, an expected average of two days.]

Secondary ID(s)

SifaU

Source(s) of Monetary Support

Please refer to primary and secondary sponsors