An interventional study of fluid therapy, 300 ml of crystalloid Ringer's solution. in Pre-Eclampsia, Hypotension and Fluid Overload, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Among 79 studies in Pre-Eclampsia with a site in Egypt — 11 open to participants now, 12 under way, none of them phase 3. Pre-Eclampsia · Egypt.
Among the 79 studies in Pre-Eclampsia with a site in Egypt, this one is the 23rd largest by planned enrollment of the 40 interventional ones that give a count, is one of 10 that started in 2024, is one of 21 with no phase, reaches primary completion later than 1 of the 11 other live ones, and was the 65th registered.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
Browse Pre-Eclampsia studies →11 of the 79 studies in Pre-Eclampsia with a site in Egypt are open now. Recruiting first, the newest first:
Cairo University · Sites in Egypt
Ages 20–40 · Women only
Tanta University · Sites in Egypt
Ages 18–40 · Women only · Healthy volunteers
South Valley University · Sites in Egypt
Ages 18–50 · Women only · Healthy volunteers
Ain Shams Maternity Hospital · Sites in Egypt
Ages 18+ · Women only
Ain Shams University · Sites in Egypt
Women only
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: female · no healthy volunteers.
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79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 6 · Phase 4 9
First in 2013; this study’s year is marked. 10 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is below the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Median enrollment 100 across the 40 interventional studies, 90 across the 39 observational. Of the 39 that completed or were terminated, 0 (0%) have results posted.
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1 of 79 have an industry lead sponsor. The 10 most frequent:
Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 8 studies filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
2 of the studies in Pre-Eclampsia with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07423741South Valley UniversityUltrasonographical Assessment of Airway Indices in Pregnancy | 2026-11 |
| NCT07443345Cairo UniversityIncidence of Postoperative Diaphragmatic Dysfunction in Pregnant Women With Preeclampsia | 2026-12-30 |
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Among the 79 studies in Pre-Eclampsia with a site in Egypt, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
the participants in this group will receive crystalloids according to the IVCCI assessment as follows: 1. If ≥ 50 % a bolus will be given 300 ml by dripping within 30 minutes, the fluid will be repeated by half the amount if needed to reach equal or less than 40% collapsibility. 2. If \< 50 % or B line finding in lung ultrasound no bolus will be given.
Other: fluid therapy, 300 ml of crystalloid Ringer's solution.
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.
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.
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.
Time frame: 20 minutes after the spinal anesthesia injection
occurrence of complication
occurrence of any complications such as pulmonary edema, need for intraoperative vasopressors.
Time frame: from spinal anesthesia till the delivery of the fetus, or within 30 minutes postspinal which comes first
Plan to share: Yes — de-identified individual participant data (IPD) will be available to other researchers
Supporting information: Study protocol
Time frame: After publishing the protocol in a relevant journal. will be available through that journal and according to the regulation
Access criteria: the published protocol will be either free or through a subscription according to the journal.
Started Aug 2024 (actual). Primary completion is estimated for Nov 2024, 3 months after the start.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 3 months is below that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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