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Effect of Intravenous Oxytocin on Post Dural Puncture Headache After Caesarean Sections
Plain-language guide to NCT07853924: phase 4 randomized trial of Oxytocin, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07853924
- Phase
- phase 4
- Status
- not yet recruiting
- Start
- 2026-09
- Completion (planned or actual)
- 2027-09
- Participants
- 100 (estimated)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Post Dural Puncture Headache
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Oxytocin.
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.
It had two arms (groups): Group O : Oxytocin Group (active comparator) and 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.
The registry classes the interventions as drug.
Who Took Part
100 planned participants were the target.
It was open to women only aged from 18 years up to 45 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could 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.
The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: patient refusal to participate; known hypersensitivity or allergic reaction to oxytocin; diabetes mellitus complicated by polyneuropathy.
How the Study Was Run
The set-up was randomized, parallel-group and single-blind.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
The Oxytocin group and the comparison group ran side by side rather than switching.
Only one side, usually the participants, was kept unaware of whether Oxytocin was given.
Those kept unaware of assignments: outcomes assessor.
It started in 2026-09 with completion listed for 2027-09.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: the change in headache pain intensity (time frame: 72 hours).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Oxytocin in 100 people.
Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.