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NCT Number: NCT03252496

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

This study will compare between combination of colloids/crystalloids and crystalloids in women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia

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Key information

Conditions

Pre-eclampsia Cesarean Section Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Spinal anesthesia

Procedure

Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle

Intrathecal Bupivacaine

Drug

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Intrathecal Fentanyl

Drug

Fentanyl 15 μg will be administered in the subarachnoid space

Cesarean Delivery

Procedure

Lower segment cesarean section using the Pfannenstiel incision

Ultrasound Assessment of the Inferior Vena Cava

Radiation

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

250 mL Colloid over 5 minutes

Drug

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

250 mL Crystalloid over 5 minutes

Drug

Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection

500 mL Crystalloid over 55 minutes

Drug

Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration

250 mL Colloid over 60 minutes

Drug

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

250 mL Crystalloid over 60 minutes

Drug

After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes

Intravenous Ephedrine

Drug

Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.

Intravenous Syntocinon

Drug

Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution

Primary outcomes

  1. Total urine output at 2 hours post-spinal

    Time frame: 2 hours after intrathecal injection

Secondary outcomes

  1. Urine output at 1 hour post-spinal

    Time frame: 1 hour after intrathecal injection

  2. Incidence of oliguria

    Time frame: 2 hours after intrathecal injection

    Total urine output at 2 hours post-spinal <60 mL

  3. Total ephedrine dose

    Time frame: Intraoperative

  4. Pre-delivery ephedrine dose

    Time frame: From intrathecal injection until delivery

  5. Number of patients requiring ephedrine

    Time frame: Intraoperative

  6. Number of patients requiring ephedrine pre-delivery

    Time frame: From intrathecal injection until delivery

  7. Incidence of nausea and/or vomiting

    Time frame: Intraoperative

  8. Incidence of bradycardia

    Time frame: Intraoperative

    Heart rate <50 beats/minute

  9. 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

  10. 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

  11. Neonatal Apgar score

    Time frame: At 1 and 5 minutes after delivery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2017
Registry last updated
Sep 5, 2021

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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