Epidural hydroxyethyl starch to prevent post-dural puncture headache in parturients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective cohort project investigates the effect of epidural hydroxyethyl starch (HES) filling on preventing PDPH after accidental dural puncture in parturients. Participants are women aged 18 or older who experienced ADP during neuraxial anesthesia for labor analgesia or cesarean delivery. The study compares outcomes between those receiving TEG/epidural HES filling and those who do not, across several Chinese hospitals. Background data describe the incidence of ADP and PDPH, current conservative and pharmacologic treatments, and the rationale for using epidural HES to reduce CSF leakage. The study design is observational, focusing on real-world practice across multiple centers to assess feasibility and potential benefit. Primary endpoints likely include incidence and severity of PDPH, with secondary outcomes on analgesic requirements and recovery metrics.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Haidian Maternal and Child Health Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Ningxia Maternal and Child Health Hospital
  Yinchuan, Ningxia, China Not yet recruiting
• Taiyuan central hospital
  Taiyuan, Shanxi, China Not yet recruiting

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Zhi-Yu Geng, MD
• Email: gengzhiyu2013@163.com
• Phone: 86 10 83572460

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.