Postdural Puncture HeadachePROPHYDRANCT02859233
Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache
A study testing Lack of hyperhydration in people with Postdural Puncture Headache, run by Nantes University Hospital at 4 sites in France.
Trial summary
Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postdural Puncture Headache
- What is being tested?
- Lack of hyperhydration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Nov 2016to 23 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient in need of dural puncture for diagnostic.
- Age between 18 and 60 years old.
- Patient willing to participate in the research.
Who cannot join
- Pregnancy.
- Contraindication for increased oral fluid intake.
- Previous dural puncture within 5 day prior enrollment.
- Parenteral fluid intake superior at 266 ml for 2 hours after dural puncture (1000 ml per day).
- Enteral artificial feeding.
- Patient not in capacity to understand correctly French.
- Patient whose cannot be followed correctly by phone.
- Patient refusing to participate in the study.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hospital centre CHD VENDEE
La Roche-sur-Yon, 85925
Hospital centre LE MANS
Le Mans, 72037
University Hospital NANTES
Nantes, 44093
Hospital centre CORNOUAILLE
Quimper, 29107
About this study
Official title: Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial
Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.
For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice, in the standard patient care.
Read more
The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH.
The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.
Read the detailed description
Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.
For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice by non-inferiority study, in the standard patient care.
The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH. It will be evaluated on the occurrence of PDPH in both of the two groups The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.
- Conditions
- Postdural Puncture Headache
- Being tested
- Lack of hyperhydration
- Keywords
- Spinal Puncture, Dural puncture, Nursing
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lack of hyperhydrationOther
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Routine advices about the interest of increase fluid after lumbar puncture to prevent PDPH will be transmitted: 2 liters will be provided to be drunk in 2 hours. |
| Interventional group | Experimental | Lack of hyperhydration : no particular advices will be transmitted about the interest of oral hyperhydration. 500 milliliters will be provided in case of thirst, according to patient's convenience. Receives: Other: Lack of hyperhydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PDPH.
PDPH will be observed on the 5th day (D5) after the lumbar puncture (D0). If PDPH is still present on the 5th day, the patient continues to be followed until the 8th day after the lumbar puncture
Measured: At D5
The incidence of PDPH (in case of PDPH still present at D5).
PDPH will be observed also on the 8th day (D8) after the lumbar puncture (D0). , if PDPH was still present on the 5th day, to confirm the diagnosis of PDPH.
Measured: At D8
Secondary outcomes (1)
The date of apparition of PDPH between day 0 and day 5
Measured: between day 0 and day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start8 Nov 2016
- Primary completion23 Jul 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle CARTRON, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859233
- Sponsor's protocol ID
- RC16_0031
- Acronym
- PROPHYDRA
- Status last verified
- Aug 2019
- First submitted
- 21 Jul 2016
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276Arevalo-Rodriguez I, Ciapponi A, Roque i Figuls M, Munoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3.
PubMed 26950232Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches [RETIRED]: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.
PubMed 16116106Dieterich M, Brandt T. Incidence of post-lumbar puncture headache is independent of daily fluid intake. Eur Arch Psychiatry Neurol Sci. 1988;237(4):194-6. doi: 10.1007/BF00449906.
PubMed 3203698Cartron E, Volteau C, Leroy M, Voisine A, Dauvergne JE, Ballet C, Talarmin JP, Queau MA, Catinault M, Gazeau E, Haubertin C, Charreau R, Boutoille D. Oral fluid supplementation for the prevention of post-dural puncture headache: A noninferiority randomized controlled trial. PLoS One. 2025 Mar 12;20(3):e0319481. doi: 10.1371/journal.pone.0319481. eCollection 2025.
PubMed 40073366
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02859233
- Acronym / sponsor ID
- PROPHYDRA / RC16_0031
- Conditions
- Postdural Puncture Headache
- Keywords
- Spinal Puncture, Dural puncture, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.
For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice, in the standard patient care.
The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH.
The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.
Detailed description
Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.
For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice by non-inferiority study, in the standard patient care.
The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH. It will be evaluated on the occurrence of PDPH in both of the two groups The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Routine advices about the interest of increase fluid after lumbar puncture to prevent PDPH will be transmitted: 2 liters will be provided to be drunk in 2 hours. |
| Interventional group | Experimental | Other: Lack of hyperhydrationLack of hyperhydration : no particular advices will be transmitted about the interest of oral hyperhydration. 500 milliliters will be provided in case of thirst, according to patient's convenience. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient in need of dural puncture for diagnostic.
- Age between 18 and 60 years old.
- Patient willing to participate in the research.
Key exclusion criteria (8 listed)
- Pregnancy.
- Contraindication for increased oral fluid intake.
- Previous dural puncture within 5 day prior enrollment.
- Parenteral fluid intake superior at 266 ml for 2 hours after dural puncture (1000 ml per day).
- Enteral artificial feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lack of hyperhydration | Other | Interventional group |
Primary outcome
The incidence of PDPH.
Time frame: At D5
PDPH will be observed on the 5th day (D5) after the lumbar puncture (D0). If PDPH is still present on the 5th day, the patient continues to be followed until the 8th day after the lumbar puncture
The incidence of PDPH (in case of PDPH still present at D5).
Time frame: At D8
PDPH will be observed also on the 8th day (D8) after the lumbar puncture (D0). , if PDPH was still present on the 5th day, to confirm the diagnosis of PDPH.
1 secondary outcome
The date of apparition of PDPH between day 0 and day 5
Time frame: between day 0 and day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Background: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Background: PubMed 26950232Arevalo-Rodriguez I, Ciapponi A, Roque i Figuls M, Munoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3.
- Background: PubMed 16116106Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches [RETIRED]: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.
- Background: PubMed 3203698Dieterich M, Brandt T. Incidence of post-lumbar puncture headache is independent of daily fluid intake. Eur Arch Psychiatry Neurol Sci. 1988;237(4):194-6. doi: 10.1007/BF00449906.
- Derived from this study: PubMed 40073366Cartron E, Volteau C, Leroy M, Voisine A, Dauvergne JE, Ballet C, Talarmin JP, Queau MA, Catinault M, Gazeau E, Haubertin C, Charreau R, Boutoille D. Oral fluid supplementation for the prevention of post-dural puncture headache: A noninferiority randomized controlled trial. PLoS One. 2025 Mar 12;20(3):e0319481. doi: 10.1371/journal.pone.0319481. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle CARTRON principal investigator
Nantes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lack of hyperhydration in people with Postdural Puncture Headache, run by Nantes University Hospital at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PDPH. (time frame: At D5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02859233, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.