NCT07914790 Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
| NCT ID | NCT07914790 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Parturients |
| Study Type | OBSERVATIONAL |
| Enrollment | 410 participants |
| Start Date | 2026-11-04 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 410 participants in total. It began in 2026-11-04 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The incidence of accidental dural puncture (ADP) among parturients receiving neuraxial labor analgesia has been reported to range from 1% to 1.5%. Post-dural puncture headache (PDPH) is a headache caused by low cerebrospinal fluid pressure resulting from substantial cerebrospinal fluid leakage after dural and arachnoid puncture. Epidural filling with hydroxyethyl starch (HES) via an epidural catheter has been used to prevent PDPH in patients with ADP. This multicenter prospective cohort study aimed to evaluate the effect of epidural HES filling in preventing PDPH in parturients who experienced ADP during epidural labor analgesia or neuraxial anesthesia for cesarean delivery.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years. 2. Have experienced accidental dural puncture (ADP) during epidural labor analgesia or neuraxial anesthesia for cesarean delivery. Exclusion Criteria: 1. Age \<18 years. 2. ASA physical status ≥IV. 3. Cesarean delivery under general anesthesia. 4. Preoperative inability to communicate due to intellectual or language impairment. 5. Pre-existing cerebrovascular disease, migraine, or chronic headache. 6. Long-term use of oral analgesics. 7. Preoperative coagulation dysfunction. 8. Platelet count \<80×10⁹/L. 9. Refusal to participate.
Contact & Investigator
Dong-Xin Wang, MD, PhD
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT07914790 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Parturients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07914790 currently recruiting?
Yes, NCT07914790 is actively recruiting participants. Contact the research team at gengzhiyu2013@163.com for enrollment information.
Where is the NCT07914790 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Yinchuan, China, Taiyuan, China.
Who is sponsoring the NCT07914790 clinical trial?
NCT07914790 is sponsored by Peking University First Hospital. The principal investigator is Dong-Xin Wang, MD, PhD at Peking University First Hospital. The trial plans to enroll 410 participants.