search
Back to results

Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery

Primary Purpose

Pre-Eclampsia, Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Spinal Anesthesia
Intrathecal Bupivacaine
Intrathecal Fentanyl
Cesarean Delivery
Ultrasound Assessment of the Inferior Vena Cava
250 mL Colloid over 5 minutes
250 mL Crystalloid over 5 minutes
500 mL Crystalloid over 55 minutes
250 mL Colloid over 60 minutes
250 mL Crystalloid over 60 minutes
Intravenous Ephedrine
Intravenous Syntocinon
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-Eclampsia

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Anesthesia, Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination

Crystalloid

Arm Description

250 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.

250 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.

Outcomes

Primary Outcome Measures

Total urine output at 2 hours post-spinal

Secondary Outcome Measures

Urine output at 1 hour post-spinal
Incidence of oliguria
Total urine output at 2 hours post-spinal <60 mL
Total ephedrine dose
Pre-delivery ephedrine dose
Number of patients requiring ephedrine
Number of patients requiring ephedrine pre-delivery
Incidence of nausea and/or vomiting
Incidence of bradycardia
Heart rate <50 beats/minute
Maximum and minimum inferior vena cava diameters
Inferior vena cava collapsibility index
Neonatal Apgar score

Full Information

First Posted
August 14, 2017
Last Updated
September 3, 2021
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT03252496
Brief Title
Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery
Official Title
Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 19, 2017 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare between combination of colloids/crystalloids and crystalloids in women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia
Detailed Description
This randomized, controlled, double blind study will be conducted on women with preeclampsia with singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Immediately, after spinal anesthesia administration, patients will receive either 250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes (Combination group) or 250 mL crystalloid over 5 minutes followed by 500 mL over 55 minutes then 250 mL over 60 minutes (Crystalloid group). The studied maternal outcomes will be the urine output, ephedrine requirement, incidence of hypotension, inferior vena cava diameters, nausea/vomiting and bradycardia. Neonatal Apgar scores will be recorded at 1 and 5 minutes post-delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia, Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination
Arm Type
Experimental
Arm Description
250 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.
Arm Title
Crystalloid
Arm Type
Active Comparator
Arm Description
250 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.
Intervention Type
Procedure
Intervention Name(s)
Spinal Anesthesia
Intervention Description
Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
Intervention Type
Drug
Intervention Name(s)
Intrathecal Bupivacaine
Intervention Description
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Intervention Type
Drug
Intervention Name(s)
Intrathecal Fentanyl
Intervention Description
Fentanyl 15 μg will be administered in the subarachnoid space
Intervention Type
Procedure
Intervention Name(s)
Cesarean Delivery
Intervention Description
Lower segment cesarean section using the Pfannenstiel incision
Intervention Type
Radiation
Intervention Name(s)
Ultrasound Assessment of the Inferior Vena Cava
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
250 mL Colloid over 5 minutes
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
250 mL Crystalloid over 5 minutes
Intervention Description
Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
Intervention Type
Drug
Intervention Name(s)
500 mL Crystalloid over 55 minutes
Intervention Description
Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
Intervention Type
Drug
Intervention Name(s)
250 mL Colloid over 60 minutes
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
250 mL Crystalloid over 60 minutes
Intervention Description
After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes
Intervention Type
Drug
Intervention Name(s)
Intravenous Ephedrine
Intervention Description
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
Intervention Type
Drug
Intervention Name(s)
Intravenous Syntocinon
Intervention Description
Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution
Primary Outcome Measure Information:
Title
Total urine output at 2 hours post-spinal
Time Frame
2 hours after intrathecal injection
Secondary Outcome Measure Information:
Title
Urine output at 1 hour post-spinal
Time Frame
1 hour after intrathecal injection
Title
Incidence of oliguria
Description
Total urine output at 2 hours post-spinal <60 mL
Time Frame
2 hours after intrathecal injection
Title
Total ephedrine dose
Time Frame
Intraoperative
Title
Pre-delivery ephedrine dose
Time Frame
From intrathecal injection until delivery
Title
Number of patients requiring ephedrine
Time Frame
Intraoperative
Title
Number of patients requiring ephedrine pre-delivery
Time Frame
From intrathecal injection until delivery
Title
Incidence of nausea and/or vomiting
Time Frame
Intraoperative
Title
Incidence of bradycardia
Description
Heart rate <50 beats/minute
Time Frame
Intraoperative
Title
Maximum and minimum inferior vena cava diameters
Time Frame
Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal
Title
Inferior vena cava collapsibility index
Time Frame
Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal
Title
Neonatal Apgar score
Time Frame
At 1 and 5 minutes after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Tawfik, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery

We'll reach out to this number within 24 hrs