Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Two Fluid Strategies for Prevention of Post-dural Puncture Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03475784
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Post-Dural Puncture Headache Drug: Restrictive fluid therapy Drug: Liberal fluid therapy Phase 3

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Two Fluid Strategies for Prevention of Post-dural Puncture Headache After Cesarean Delivery
Actual Study Start Date : March 30, 2018
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : November 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Restricted fluid therapy group
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
This group will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour.
Other Name: Restrictive fluids

Active Comparator: Liberal fluid therapy group
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 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.
Other Name: Liberal fluids




Primary Outcome Measures :
  1. Incidence of post-dural puncture headache [ Time Frame: 48 hours ]
    the number of patients who develop post-dural puncture headache defined as pain scale above 4


Secondary Outcome Measures :
  1. incidence of post-spinal hypotension [ Time Frame: 60 minutes ]
    number of patients who develop hypotension defined as decrease of systolic blood pressure by more than 20% from the baseline reading after subarachnoid block

  2. Wong-Baker faces pain scale [ Time Frame: 48 hours ]
    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

  3. heart rate [ Time Frame: 24 hours ]
    the number of heart beats per minute

  4. postoperative nausea and vomiting [ Time Frame: 24 hours ]
    the number of patients who develop postoperative nausea and vomiting



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475784


Locations
Layout table for location information
Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Study Chair: Tarek Abdelbarr, Professor Head of obstetric anesthesia section in anesthesia department
Layout table for additonal information
Responsible Party: Ahmed Hasanin, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03475784    
Other Study ID Numbers: N-98-2017
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Post-Dural Puncture Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases