Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients

October 29, 2026 updated by: Dong-Xin Wang, Peking University First Hospital

Effect of Epidural Hydroxyethyl Starch Administration for Prevention of Post-Dural Puncture Headache in Parturients: A Multi-center Prospective Cohort Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Accidental dural puncture (ADP) is a common complication of epidural puncture. Studies have reported that the incidence of ADP among parturients receiving neuraxial labor analgesia ranges from 1% to 1.5%. Post-dural puncture headache (PDPH) is a headache caused by low cerebrospinal fluid (CSF) pressure resulting from substantial CSF leakage after dural and arachnoid puncture. It typically occurs when the dura is accidentally punctured by a relatively large 16- or 18-gauge epidural needle during epidural labor analgesia or anesthesia, and occasionally after spinal anesthesia or combined spinal-epidural anesthesia performed with a 25-gauge fine needle. The literature reports that the incidence of PDPH among parturients undergoing neuraxial puncture is 0.4% to 1.5%, and that the incidence of PDPH after ADP is 50% to 80%, which is far higher than that in non-obstetric patients.

Current guideline-recommended treatments for PDPH include: (1) nonpharmacological conservative treatment, including oral fluids or intravenous hydration to maintain or increase CSF production, bed rest, and use of an abdominal binder. Although commonly used, their efficacy remains uncertain. (2) Pharmacological treatment: multimodal analgesia with acetaminophen and nonsteroidal anti-inflammatory drugs is recommended, and short-term opioid use may also be considered. Although these can relieve some symptoms, the potential transfer of drugs into breast milk and effects on the neonate should be considered at high doses. (3) Epidural blood patch (EBP) is the recommended standard treatment. It involves slow, fractionated injection of 15-20 mL of autologous blood into the epidural space, which increases epidural pressure, redistributes CSF, and forms a local blood clot that seals the dural tear, thereby reducing CSF leakage and gradually relieving the headache. However, not all patients with ADP develop PDPH; a strategy of routine prophylactic EBP would expose some patients to unnecessary potential risks.

Epidural filling with crystalloids or colloids is another alternative treatment option, which involves injecting normal saline, dextran, or hydroxyethyl starch (HES) through an epidural catheter to increase CSF pressure. Bel et al. reported a case in which epidural dextran filling successfully treated spontaneous intracranial hypotension in a pregnant woman. Aldrete et al. reported 13 patients with PDPH refractory to EBP whose headaches completely resolved after epidural dextran filling. Reynvoet et al. reported a patient with PDPH accompanied by hearing loss in whom two EBPs failed to relieve symptoms; at 8 weeks, epidural dextran filling was performed, and the symptoms completely resolved. Case reports from China and other countries have also described the preventive and therapeutic effects of epidural HES filling for the prevention and treatment of PDPH, with no adverse events reported during long-term follow-up.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing Municipality, China, 100080
        • Beijing Haidian Maternal and Child Health Hospital
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750001
        • Ningxia Maternal and Child Health Hospital
        • Contact:
    • Shanxi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population comprised parturients aged ≥18 years who experienced accidental dural puncture (ADP) during epidural labor analgesia or neuraxial anesthesia for cesarean delivery at the participating centers during the enrollment period.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Epidural hydroxyethyl starch group

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.
Drug: 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.

Other Names:
  • Epidural filling with hydroxyethyl starch
Non epidural hydroxyethyl starch group

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.
Drug: 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.

Other Names:
  • No epidural filling with hydroxyethyl starch

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of post-dural puncture headache (PDPH) within 7 days.
Time Frame: Up to 7 days after accidental dural puncture.

According to the International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria for post-dural puncture headache (PDPH), PDPH is defined as: a history of dural puncture; headache occurring within 5 days after dural puncture; headache consistent with low cerebrospinal fluid pressure headache; and not better accounted for by another ICHD-3 diagnosis.
Up to 7 days after accidental dural puncture.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of post-dural puncture headache (PDPH)
Time Frame: Up to 2 weeks after accidental dural puncture.

Duration of PDPH is defined as the time from the onset of PDPH to complete resolution of headache, recorded in days. Patients without resolution by the end of follow-up will be censored at the last follow-up visit.
Up to 2 weeks after accidental dural puncture.
Severity of post-dural puncture headache (PDPH)
Time Frame: Up to 2 weeks after accidental dural puncture.

PDPH severity was graded on a 0-10 numeric rating scale (NRS) as mild (1-3), moderate (4-6), or severe (7-10).
Up to 2 weeks after accidental dural puncture.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Haidian Maternal and Child Health Hospital
Taiyuan central hospital
Ningxia Maternal and Child Health Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026R0413-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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