ClinicalTrials.Veeva

Menu

Two Fluid Strategies for Prevention of Post-dural Puncture Headache

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 3

Conditions

Post-Dural Puncture Headache

Treatments

Drug: Liberal fluid therapy
Drug: Restrictive fluid therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03475784
N-98-2017

Details and patient eligibility

About

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

Full description

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.

Enrollment

100 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Full term
  • Pregnant female
  • Scheduled to elective cesarean delivery

Exclusion criteria

  • History of migraine headache
  • Hypertensive disorders of pregnancy
  • Cardiac morbidities,
  • Baseline systolic blood pressure < 100 mmHg
  • Contraindication of regional anesthesia.
  • Patients with more than one single attempt for spinal block

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Restricted fluid therapy group
Experimental group
Description:
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.
Treatment:
Drug: Restrictive fluid therapy
Liberal fluid therapy group
Active Comparator group
Description:
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.
Treatment:
Drug: Liberal fluid therapy

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems