Post Dural Puncture HeadachePhase 4NCT07853924
Effect of Intravenous Oxytocin on Post Dural Puncture Headache After Caesarean Sections
A Phase 4 study testing oxytocin and Normal Saline in people with Post Dural Puncture Headache, run by Assiut University.
Trial summary
Spinal anesthesia is the preferred anesthetic technique for cesarean section because of its advantages over epidural and general anesthesia. It is simple to perform, economical, provides rapid onset of anesthesia, and produces satisfactory muscle relaxation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Dural Puncture Headache
- What is being tested?
- oxytocin and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged >18 and ≤45 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients undergoing cesarean section under spinal anesthesia.
- Patients who develop clinically established PDPH during postoperative follow-up.
- Patients who provide written informed consent to participate in the study.
Who cannot join
- Patient refusal to participate.
- Known hypersensitivity or allergic reaction to oxytocin.
- Significant cardiac disease or other clinically important cardiovascular instability.
- Significant hepatic or renal disease.
- Diabetes mellitus complicated by polyneuropathy.
- ASA physical status III-IV.
Show all 10Show fewer
- Known neurological or neuromuscular disorders.
- History of recurrent headache or migraine.
- Any contraindication to the planned conventional treatment.
- Headache attributable to another identifiable cause or clinical suspicion of a secondary headache requiring further investigation.
About this study
Spinal anesthesia is the preferred anesthetic technique for cesarean section because of its advantages over epidural and general anesthesia. It is simple to perform, economical, provides rapid onset of anesthesia, and produces satisfactory muscle relaxation. However, spinal anesthesia may be associated with adverse effects, including nausea, vomiting, back pain, and post-dural puncture headache (PDPH)(1).
PDPH is a well-recognized complication of dural puncture. It is typically characterized by a headache that is fronto-occipital in type after spinal anesthesia puncture which gets worse after 15 minutes of standing or sitting and relieved after 15 minutes of lying down(3). The incidence of PDPH remains considerably high in younger women population reaching 20.6% which was reported in 2025(10). Most cases develop within the first few days following dural puncture. Obstetric patients are particularly susceptible because female sex, young age, and pregnancy are recognized risk factors(3).
Read more
PDPH can significantly interfere with maternal comfort, mobility, breastfeeding, and infant care, and may prolong hospitalization and increase healthcare utilization.
Oxytocin is a neurohypophyseal hormone with recognized peripheral and central effects(5). In addition to its established obstetric actions, oxytocin has been investigated for potential analgesic and neurovascular effects. Previous work has suggested a possible role of oxytocin in headache modulation(7-8); however, evidence regarding intravenous oxytocin as a treatment for established PDPH remains limited(8).
The present study is designed to evaluate whether intravenous oxytocin, when added to standardized conventional treatment, can reduce the severity and duration of established PDPH after cesarean section performed under spinal anesthesia, compared with conventional treatment alone(11).
Although several conservative and interventional approaches are available for PDPH, there is limited evidence regarding intravenous oxytocin as an adjunctive treatment for established PDPH. A randomized controlled trial comparing standardized conventional treatment with conventional treatment plus intravenous oxytocin may provide more reliable evidence regarding the clinical efficacy and safety of this intervention.
Intravenous oxytocin administered as an adjunct to standardized conventional treatment will reduce the severity of established PDPH and may shorten its duration and decrease the requirement for rescue analgesia compared with conventional treatment alone.
- Conditions
- Post Dural Puncture Headache
- Being tested
- oxytocin, Normal Saline
- 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.
oxytocinDrug
Participants will receive intravenous oxytocin with a dose of 15 IU of oxytocin diluted in 500 ml normal saline and infused slowly over 1 hour every 12 hours for a duration of 24 hours.
Normal SalineDrug
Participants will receive The Saline control solution should be identical in volume and appearance to the study infusion whenever blinding is feasible
| Study group | Role | What they receive |
|---|---|---|
| Group O : Oxytocin Group | Active comparator | Participants will receive standardized conventional treatment for PDPH plus intravenous oxytocin with a dose of 15 IU of oxytocin diluted in 500 ml normal saline and infused slowly over 1 hour every 12 hours for a duration of 24 hours. Receives: Drug: oxytocin |
| Group C - Control Group | Placebo comparator | : Participants will receive the same standardized conventional treatment for PDPH plus an equivalent control infusion without oxytocin. The control solution should be identical in volume and appearance to the study infusion whenever blinding is feasible. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in headache pain intensity
the change in headache pain intensity (VAS/NRS) from baseline immediately before treatment to a predefined primary assessment time point after treatment.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdel Khaliq Ayman Abdel Khaliq, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853924
- Sponsor's protocol ID
- oxytocin PDPH AFTER CS
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Oxytocin on Post Dural Puncture Headache After Caesarean Sections
- ClinicalTrials.gov ID
- NCT07853924
- Acronym / sponsor ID
- oxytocin PDPH AFTER CS
- Conditions
- Post Dural Puncture Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- 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.
Spinal anesthesia is the preferred anesthetic technique for cesarean section because of its advantages over epidural and general anesthesia. It is simple to perform, economical, provides rapid onset of anesthesia, and produces satisfactory muscle relaxation. However, spinal anesthesia may be associated with adverse effects, including nausea, vomiting, back pain, and post-dural puncture headache (PDPH)(1).
PDPH is a well-recognized complication of dural puncture. It is typically characterized by a headache that is fronto-occipital in type after spinal anesthesia puncture which gets worse after 15 minutes of standing or sitting and relieved after 15 minutes of lying down(3). The incidence of PDPH remains considerably high in younger women population reaching 20.6% which was reported in 2025(10). Most cases develop within the first few days following dural puncture. Obstetric patients are particularly susceptible because female sex, young age, and pregnancy are recognized risk factors(3).
PDPH can significantly interfere with maternal comfort, mobility, breastfeeding, and infant care, and may prolong hospitalization and increase healthcare utilization.
Oxytocin is a neurohypophyseal hormone with recognized peripheral and central effects(5). In addition to its established obstetric actions, oxytocin has been investigated for potential analgesic and neurovascular effects. Previous work has suggested a possible role of oxytocin in headache modulation(7-8); however, evidence regarding intravenous oxytocin as a treatment for established PDPH remains limited(8).
The present study is designed to evaluate whether intravenous oxytocin, when added to standardized conventional treatment, can reduce the severity and duration of established PDPH after cesarean section performed under spinal anesthesia, compared with conventional treatment alone(11).
Although several conservative and interventional approaches are available for PDPH, there is limited evidence regarding intravenous oxytocin as an adjunctive treatment for established PDPH. A randomized controlled trial comparing standardized conventional treatment with conventional treatment plus intravenous oxytocin may provide more reliable evidence regarding the clinical efficacy and safety of this intervention.
Intravenous oxytocin administered as an adjunct to standardized conventional treatment will reduce the severity of established PDPH and may shorten its duration and decrease the requirement for rescue analgesia compared with conventional treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group O : Oxytocin Group | Active comparator | Drug: oxytocinParticipants will receive standardized conventional treatment for PDPH plus intravenous oxytocin with a dose of 15 IU of oxytocin diluted in 500 ml normal saline and infused slowly over 1 hour every 12 hours for a duration of 24 hours. |
| Group C - Control Group | Placebo comparator | Drug: Normal Saline: Participants will receive the same standardized conventional treatment for PDPH plus an equivalent control infusion without oxytocin. The control solution should be identical in volume and appearance to the study infusion whenever blinding is feasible. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female patients aged >18 and ≤45 years.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Patients undergoing cesarean section under spinal anesthesia.
- Patients who develop clinically established PDPH during postoperative follow-up.
- Patients who provide written informed consent to participate in the study.
Key exclusion criteria (10 listed)
- Patient refusal to participate.
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 |
|---|---|---|
| oxytocinParticipants will receive intravenous oxytocin with a dose of 15 IU of oxytocin diluted in 500 ml normal saline and infused slowly over 1 hour every 12 hours for a duration of 24 hours. | Drug | Group O : Oxytocin Group |
| Normal SalineParticipants will receive The Saline control solution should be identical in volume and appearance to the study infusion whenever blinding is feasible | Drug | Group C - Control Group |
Primary outcome
the change in headache pain intensity
Time frame: 72 hours
the change in headache pain intensity (VAS/NRS) from baseline immediately before treatment to a predefined primary assessment time point after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Related trials for Post Dural Puncture Headache
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oxytocin and Normal Saline in people with Post Dural Puncture Headache, run by Assiut University.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 change in headache pain intensity (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.