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Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Sponsor: Peking University First Hospital
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.
Official title: Effect of Epidural Hydroxyethyl Starch Administration for Prevention of Post-Dural Puncture Headache in Parturients: A Multi-center Prospective Cohort Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
410
Start Date
2026-11
Completion Date
2030-06
Last Updated
2026-11-04
Healthy Volunteers
No
Conditions
Interventions
Epidural hydroxyethyl starch
For parturients with accidental dural puncture during labor epidural analgesia, after successful reinsertion of the epidural catheter at a different interspace, 15 mL of hydroxyethyl starch (HES) will be administered into the epidural space at two time points: the first at 30 minutes after the initial epidural dose administered through the reinserted catheter, and the second before catheter removal 24 hours after delivery. For parturients with accidental dural puncture during cesarean delivery, 15 mL of HES will be administered into the epidural space at two time points: after delivery of the fetus and before catheter removal at the end of the 48-hour analgesia period.
No epidural hydroxyethyl starch
For parturients with accidental dural puncture during labor epidural analgesia, after successful reinsertion of the epidural catheter at a different interspace, no HES will be administered into the epidural space in the control group. The corresponding time points in the intervention group are 30 minutes after the initial epidural dose administered through the reinserted catheter and before catheter removal 24 hours after delivery. For parturients with accidental dural puncture during cesarean delivery, no HES will be administered into the epidural space in the control group. The corresponding time points in the intervention group are after delivery of the fetus and before catheter removal at the end of the 48-hour analgesia period.
Locations (4)
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Haidian Maternal and Child Health Hospital
Beijing, Beijing Municipality, China
Ningxia Maternal and Child Health Hospital
Yinchuan, Ningxia, China
Taiyuan central hospital
Taiyuan, Shanxi, China