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Pre-EclampsiaNCT03252496

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

A study testing Spinal Anesthesia, Intrathecal Bupivacaine and Intrathecal Fentanyl in people with Pre-Eclampsia and Cesarean Section, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 40 years, women only
Conditions the study is for
Pre-Eclampsia, Cesarean Section
What is being tested?
Spinal Anesthesia, Intrathecal Bupivacaine and Intrathecal Fentanyl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteEgypt
Study dates
19 Aug 2017to 15 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Department of Anesthesia, Mansoura University Hospitals

    Al Mansurah, Dakahlia Governorate, 35511

Other trials in Egypt

About this study

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

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

Read the 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.

Being tested
Spinal Anesthesia, Intrathecal Bupivacaine, Intrathecal Fentanyl, Cesarean Delivery, Ultrasound Assessment of the Inferior Vena Cava
Medical subject headings
Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal AnesthesiaProcedure or surgery

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

  • Intrathecal BupivacaineDrug

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

  • Intrathecal FentanylDrug

    Fentanyl 15 μg will be administered in the subarachnoid space

  • Cesarean DeliveryProcedure or surgery

    Lower segment cesarean section using the Pfannenstiel incision

  • Ultrasound Assessment of the Inferior Vena CavaRadiation

    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 minutesDrug

    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 minutesDrug

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

  • 500 mL Crystalloid over 55 minutesDrug

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

  • 250 mL Colloid over 60 minutesDrug

    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 minutesDrug

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

  • Intravenous EphedrineDrug

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

  • Intravenous SyntocinonDrug

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

Study groups in NCT03252496
Study groupRoleWhat they receive
CombinationExperimental250 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.
Receives: Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Procedure: Cesarean Delivery; Radiation: Ultrasound Assessment of the Inferior Vena Cava; Drug: 250 mL Colloid over 5 minutes; Drug: 500 mL Crystalloid over 55 minutes; Drug: 250 mL Colloid over 60 minutes; Drug: Intravenous Ephedrine; Drug: Intravenous Syntocinon
CrystalloidActive 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.
Receives: Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Procedure: Cesarean Delivery; Radiation: Ultrasound Assessment of the Inferior Vena Cava; Drug: 250 mL Crystalloid over 5 minutes; Drug: 500 mL Crystalloid over 55 minutes; Drug: 250 mL Crystalloid over 60 minutes; Drug: Intravenous Ephedrine; Drug: Intravenous Syntocinon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total urine output at 2 hours post-spinal

    Measured: 2 hours after intrathecal injection

Secondary outcomes (11)

  1. Urine output at 1 hour post-spinal

    Measured: 1 hour after intrathecal injection

  2. Incidence of oliguria

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

    Measured: 2 hours after intrathecal injection

  3. Total ephedrine dose

    Measured: Intraoperative

  4. Pre-delivery ephedrine dose

    Measured: From intrathecal injection until delivery

  5. Number of patients requiring ephedrine

    Measured: Intraoperative

  6. Number of patients requiring ephedrine pre-delivery

    Measured: From intrathecal injection until delivery

  7. Incidence of nausea and/or vomiting

    Measured: Intraoperative

  8. Incidence of bradycardia

    Heart rate <50 beats/minute

    Measured: Intraoperative

  9. Maximum and minimum inferior vena cava diameters

    Measured: 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

    Measured: Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal

  11. Neonatal Apgar score

    Measured: At 1 and 5 minutes after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2017
  2. Study start19 Aug 2017
  3. Primary completion15 Jul 2021
  4. Study completion15 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03252496
Sponsor's protocol ID
R/17.06.79
Status last verified
Sep 2021
First submitted
14 Aug 2017
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Anesthesia, Intrathecal Bupivacaine and Intrathecal Fentanyl in people with Pre-Eclampsia and Cesarean Section, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total urine output at 2 hours post-spinal (time frame: 2 hours after intrathecal injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03252496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.

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