A Phase 3 interventional study of Restrictive fluid therapy and Liberal fluid therapy in Post-Dural Puncture Headache, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Cairo University · Phase 3, Interventional, and Prevention
Among 31 studies in Post-Dural Puncture Headache with a site in Egypt — 5 open to participants now, 6 under way, 1 of them phase 3. Post-Dural Puncture Headache · Egypt.
Among the 31 studies in Post-Dural Puncture Headache with a site in Egypt, this one is the 13th largest by enrollment of the 29 interventional ones that give a count, is one of 5 that started in 2018, is one of 3 in phase 3, and was the 2nd registered.
122 studies on the registry are indexed under Post-Dural Puncture Headache; 27 are open to participants now.
Browse Post-Dural Puncture Headache studies →5 of the 31 studies in Post-Dural Puncture Headache with a site in Egypt are open now. Recruiting first, the newest first:
Assiut University · Sites in Egypt
Ages 18–40 · Women only
Minia University · Sites in Egypt
Ages 18–35 · Women only
Tanta University · Sites in Egypt
Ages 21–50
Al-Azhar University · Sites in Egypt
Ages 18–45 · Women only
Assiut University · Sites in Egypt
Ages 18–65
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 15 Post-Dural Puncture Headache studies recruiting now, 7 (47%) set no upper age limit and 8 (53%) stop at 75 or younger; 1 takes children under 18; none take healthy volunteers.
This study: 18 Years to 40 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 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 2 · Phase 2 3 · Phase 3 4 · Phase 4 7
First in 2018; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is above the median of 80 across 79 interventional studies indexed under Post-Dural Puncture Headache.
Median enrollment 75 across the 29 interventional studies, 120 across the 2 observational. Of the 22 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 31 has an industry lead sponsor. The 10 most frequent:
Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Cairo University has 2 studies filed under Post-Dural Puncture Headache — fewer than ten, so there is no comparison to draw.
3 of the studies in Post-Dural Puncture Headache with a site in Egypt that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07916116Phase 3Assiut UniversityOral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH | 2027-03-01 |
| NCT07360756Al-Azhar UniversityUltrasonographic ONSD as a Predictor of PDPH in Spinal Anesthesia for Cesarean Delivery | 2026-11-30 |
| NCT06824025Minia UniversityComparison of Nebulized Neostigmine/Atropine Versus Lignocaine in Treating Acute Post-dural Puncture Headache Following Subarachnoid Block in Parturient Undergoing Elective Cesarean Section. A Randomized, Clinical Trial. | 2027-01-01 |
Among the 31 studies in Post-Dural Puncture Headache with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Postdural puncture headache (PDPH) is a common complication after cesarean delivery (CD). The role of peri-operative fluid therapy in prophylaxis against PDPH is unclear. The aim of this work is to compare restrictive versus liberal fluid therapy in prophylaxis against PDPH after CD
In this study, the investigators will compare restrictive fluid therapy and liberal fluid therapy in prophylaxis against postdural puncture headache.
The restrictive group will not receive preoperative fluid loading, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour for hours. The Liberal group will receive preoperative fluid loading of 5 mL/Kg, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour, followed by postoperative crystalloids at rate of 6 mL/Kg/hour.
Both groups will be compared regarding demographic data, total peri-operative fluids, incidence of postdural puncture headache, nausea, vomiting, and intraoperative hemodynamics (heart rate and systolic blood pressure) in addition to neonatal outcomes.
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.
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.
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.
Restrictive fluid therapy: this group will not receive fluid pre-load, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2mL/Kg/hour.
Drug: Restrictive fluid therapy
Liberal fluid therapy: this group will receive fluid pre-load (5 mL/Kg), and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 6 mL/Kg/hour.
Drug: Liberal fluid therapy
This group will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour.
Also known as: Restrictive fluids
This group will receive crystalloid preload of 5 mL/Kg, then will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 6 mL/Kg/hour.
Also known as: Liberal fluids
Incidence of post-dural puncture headache
the number of patients who develop post-dural puncture headache defined as pain scale above 4
Time frame: 48 hours
incidence of post-spinal hypotension
number of patients who develop hypotension defined as decrease of systolic blood pressure by more than 20% from the baseline reading after subarachnoid block
Time frame: 60 minutes
Wong-Baker faces pain scale
Pain rating scale which is expressed by the patient starting from zero scale which corresponds to no pain, till scale 10 which corresponds to worst pain
Time frame: 48 hours
heart rate
the number of heart beats per minute
Time frame: 24 hours
postoperative nausea and vomiting
the number of patients who develop postoperative nausea and vomiting
Time frame: 24 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Oct 2018, 7 months.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Post-Dural Puncture Headache →