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The routine assessment of fluid status depends on clinical evaluation and invasive monitoring. The clinical assessment lacks objectivity and the invasive monitoring carries risks. Point of care ultrasound (POCUS) parameters can be useful as early markers of fluid status and were used in safe fluid assessment in term pregnancy and preeclampsia.
Fluid therapy in preeclamptic patients presents a challenge. volume expansion may precipitate pulmonary edema while fluid restriction may worsen renal function and may aggravate post-spinal hypotension during cesarean section.
Pre-eclampsia predisposes to maternal mortality. It presents a serious hypertensive disorder during pregnancy which may progress rapidly to serious complications, including the death of both mother and fetus The optimal fluid management strategy constitutes a cornerstone in the management. The Royal College of Obstetricians and Gynecologists (RCOG) guidelines for severe pre-eclampsia recommend restrictive fluid therapy, in keeping with the absence of evidence favoring volume expansion. Restrictive management is advocated by The Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) with additional fluid administration only recommended before intravenous hydralazine, regional anesthesia, immediate delivery, or in oliguric patients where a volume deficit is suspected.
Overall, limited evidence exists regarding the effectiveness of ultrasound assessment of the IVC collapsibility index to guide pre-operative fluid management in critically ill pre-eclamptic patients. A meta-analysis stated that few research trials are available in the obstetric population. Some studies suggest that it can accurately predict fluid responsiveness, but others argue that it may not be helpful.
Our trial is the first trial that compares the efficacy of IVCCI-guided perioperative fluid therapy against standard fluid therapy guided by clinical parameters in critically ill pre-eclamptic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVCCI-guided fluid therapy | Experimental | the participants in this group will receive crystalloids according to the IVCCI assessment as follows:
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| Conventional fluid therapy | No Intervention | the participants in this group will receive the standard regimen; no routine additional fluid within half an hour before surgery only the fixed maintenance of 80-100 ml/hr. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluid therapy, 300 ml of crystalloid Ringer's solution. | Other | 300 ml by dripping within 30 minutes, the fluid will be repeated by half the amount if needed to reach equal or less than 50% collapsibility. the fluid that will be used is sterile Ringer's solution which is an isotonic intravenous solution with pH 5.0 - 7.5 and an osmolality of 308mOsmol/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| post-spinal hypotension | post-spinal anesthesia and early intraoperative (0-20 min) hypotension (MAP < 65 mmHg and/or ≥ 20% decrease from baseline. Measured by the occurrence or not of hypotension. The aggregation method will be according to the distribution of data if normal mean and SD will be used. | 20 minutes after the spinal anesthesia injection |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of complication | occurrence of any complications such as pulmonary edema, need for intraoperative vasopressors. | from spinal anesthesia till the delivery of the fetus, or within 30 minutes postspinal which comes first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wessam selima, MD | Contact | 01001958858 | w.z.selima@med.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Recruiting | Cairo | Egypt | 11528 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37685357 | Background | Chang YJ, Liu CC, Huang YT, Wu JY, Hung KC, Liu PH, Lin CH, Lin YT, Chen IW, Lan KM. Assessing the Efficacy of Inferior Vena Cava Collapsibility Index for Predicting Hypotension after Central Neuraxial Block: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2023 Aug 31;13(17):2819. doi: 10.3390/diagnostics13172819. | |
| 34212308 |
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de-identified individual participant data (IPD) will be available to other researchers
After publishing the protocol in a relevant journal. will be available through that journal and according to the regulation
the published protocol will be either free or through a subscription according to the journal.
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D007022 | Hypotension |
| D004487 | Edema |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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a prospective, randomized, parallel-group, superior, controlled single-blinded clinical study
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| Gagne MP, Richebe P, Loubert C, Drolet P, Gobert Q, Denault A, Zaphiratos V. Ultrasound evaluation of inferior vena cava compression in tilted and supine term parturients. Can J Anaesth. 2021 Oct;68(10):1507-1513. doi: 10.1007/s12630-021-02051-w. Epub 2021 Jul 1. |
| 26782160 | Background | Hernandez CA, Reed KL, Juneman EB, Cohen WR. Changes in Sonographically Measured Inferior Vena Caval Diameter in Response to Fluid Loading in Term Pregnancy. J Ultrasound Med. 2016 Feb;35(2):389-94. doi: 10.7863/ultra.15.04036. Epub 2016 Jan 18. |
| 29398426 | Background | Pretorius T, van Rensburg G, Dyer RA, Biccard BM. The influence of fluid management on outcomes in preeclampsia: a systematic review and meta-analysis. Int J Obstet Anesth. 2018 May;34:85-95. doi: 10.1016/j.ijoa.2017.12.004. Epub 2017 Dec 20. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |