Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery
1 other identifier
interventional
140
1 country
1
Brief Summary
This study will compare between combination of colloids/crystalloids and crystalloids in women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
August 17, 2017
CompletedStudy Start
First participant enrolled
August 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2021
CompletedSeptember 5, 2021
September 1, 2021
3.9 years
August 14, 2017
September 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Total urine output at 2 hours post-spinal
2 hours after intrathecal injection
Secondary Outcomes (11)
Urine output at 1 hour post-spinal
1 hour after intrathecal injection
Incidence of oliguria
2 hours after intrathecal injection
Total ephedrine dose
Intraoperative
Pre-delivery ephedrine dose
From intrathecal injection until delivery
Number of patients requiring ephedrine
Intraoperative
- +6 more secondary outcomes
Study Arms (2)
Combination
EXPERIMENTAL250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
Crystalloid
ACTIVE COMPARATOR250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
Interventions
Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Fentanyl 15 μg will be administered in the subarachnoid space
Lower segment cesarean section using the Pfannenstiel incision
The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
After 60 minutes of intrathecal injection, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 60 minutes
After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution
Eligibility Criteria
You may qualify if:
- Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick
- Singleton pregnancy
- Elective cesarean delivery under spinal anesthesia
You may not qualify if:
- Height \<150 cm
- Weight \<60 kg
- Body mass index ≥45 kg/m2
- Women presenting in labor
- Contraindications to spinal anesthesia (increased intracranial pressure or local skin infection)
- Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
- Preoperative administration of intravenous hydralazine or magnesium sulphate
- Hemoglobin \<10 gm/dL
- International Normalized Ratio \>1.3
- Platelet count \<100,000 /mm3
- Preoperative serum creatinine \>1.1 mg/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed M Tawfik, MD
Mansoura University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer, Department of anesthesia and surgical intensive care, Primary investigator
Study Record Dates
First Submitted
August 14, 2017
First Posted
August 17, 2017
Study Start
August 19, 2017
Primary Completion
July 15, 2021
Study Completion
July 15, 2021
Last Updated
September 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share