ParturientsNCT07914790
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
An observational study of Parturients and Accidental Puncture of Dura During Anaesthesia, run by Peking University First Hospital at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parturients, Accidental Puncture of Dura During Anaesthesia, Epidural Filling
- What is being tested?
- Epidural hydroxyethyl starch and No epidural hydroxyethyl starch
- How many people
- 410 participants
- Where
- 4 sitesChina
- Study dates
- Nov 2026to Jun 2030
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years.
- Have experienced accidental dural puncture (ADP) during epidural labor analgesia or neuraxial anesthesia for cesarean delivery.
Who cannot join
- Age <18 years.
- ASA physical status ≥IV.
- Cesarean delivery under general anesthesia.
- Preoperative inability to communicate due to intellectual or language impairment.
- Pre-existing cerebrovascular disease, migraine, or chronic headache.
- Long-term use of oral analgesics.
Show all 9Show fewer
- Preoperative coagulation dysfunction.
- Platelet count <80×10⁹/L.
- Refusal to participate.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhi-Yu Geng, MD, 010-83572460, gengzhiyu2013@163.com
Beijing Haidian Maternal and Child Health Hospital
Beijing, Beijing Municipality, 100080
Bo Lei, MD, Leibo1977@163.com
Taiyuan central hospital
Taiyuan, Shanxi, 030009
Jian-Ying Ding, MD, dingjianying-2004@163.com
Ningxia Maternal and Child Health Hospital
Yinchuan, Ningxia, 750001
Hong-Ping Li, MD, 1395078537@163.com4
About this study
Official title: 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.
Read the 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.
- Conditions
- Parturients, Accidental Puncture of Dura During Anaesthesia, Epidural Filling, Hydroxyethyl Starch, Post-dural Puncture Headache
- Being tested
- Epidural hydroxyethyl starch, No epidural hydroxyethyl starch
- Keywords
- Parturients, Accidental Dural Puncture, Epidural Filling with Hydroxyethyl Starch, Post-dural Puncture Headache
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural hydroxyethyl starchDrug
Also called Epidural filling with 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 starchDrug
Also called No epidural filling with 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Epidural 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. Receives: Drug: No epidural hydroxyethyl starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-dural puncture headache (PDPH) within 7 days.
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.
Measured: Up to 7 days after accidental dural puncture.
Secondary outcomes (2)
Duration of post-dural puncture headache (PDPH)
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.
Measured: Up to 2 weeks after accidental dural puncture.
Severity of post-dural puncture headache (PDPH)
PDPH severity was graded on a 0-10 numeric rating scale (NRS) as mild (1-3), moderate (4-6), or severe (7-10).
Measured: Up to 2 weeks after accidental dural puncture.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for ParturientsStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 410 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningxia Maternal and Child Health Hospital, Beijing Haidian Maternal and Child Health Hospital, Taiyuan central hospital
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914790
- Sponsor's protocol ID
- 2026R0413-0002
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berger CW, Crosby ET, Grodecki W. North American survey of the management of dural puncture occurring during labour epidural analgesia. Can J Anaesth. 1998 Feb;45(2):110-4. doi: 10.1007/BF03013247.
PubMed 9512843Cohen S, Greenberger C, Aptekman B, Rabkin V, Weiniger CF. Incidence and management of accidental dural puncture and postdural puncture headache in parturients: Retrospective database study. Eur J Anaesthesiol. 2025 Jun 1;42(6):492-499. doi: 10.1097/EJA.0000000000002130. Epub 2025 Feb 12.
PubMed 39935247Paech M, Banks S, Gurrin L. An audit of accidental dural puncture during epidural insertion of a Tuohy needle in obstetric patients. Int J Obstet Anesth. 2001 Jul;10(3):162-7. doi: 10.1054/ijoa.2000.0825.
PubMed 15321604Guglielminotti J, Landau R, Li G. Major Neurologic Complications Associated With Postdural Puncture Headache in Obstetrics: A Retrospective Cohort Study. Anesth Analg. 2019 Nov;129(5):1328-1336. doi: 10.1213/ANE.0000000000004336.
PubMed 31335402Makito K, Matsui H, Fushimi K, Yasunaga H. Incidences and risk factors for post--dural puncture headache after neuraxial anaesthesia: A national inpatient database study in Japan. Anaesth Intensive Care. 2020 Sep;48(5):381-388. doi: 10.1177/0310057X20949555. Epub 2020 Oct 6.
PubMed 33021807Gaiser RR. Postdural Puncture Headache: An Evidence-Based Approach. Anesthesiol Clin. 2017 Mar;35(1):157-167. doi: 10.1016/j.anclin.2016.09.013.
PubMed 28131118Uppal V, Russell R, Sondekoppam R, Ansari J, Baber Z, Chen Y, DelPizzo K, Dirzu DS, Kalagara H, Kissoon NR, Kranz PG, Leffert L, Lim G, Lobo CA, Lucas DN, Moka E, Rodriguez SE, Sehmbi H, Vallejo MC, Volk T, Narouze S. Consensus Practice Guidelines on Postdural Puncture Headache From a Multisociety, International Working Group: A Summary Report. JAMA Netw Open. 2023 Aug 1;6(8):e2325387. doi: 10.1001/jamanetworkopen.2023.25387.
PubMed 37581893Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Binyamin Y, Heesen P, Orbach-Zinger S, Gozal Y, Halimi D, Frenkel A, Ioscovich A. Chronic pain in parturients with an accidental dural puncture: A case-controlled prospective observational study. Acta Anaesthesiol Scand. 2021 Aug;65(7):959-966. doi: 10.1111/aas.13816. Epub 2021 Mar 24.
PubMed 33725362Van de Velde M, Schepers R, Berends N, Vandermeersch E, De Buck F. Ten years of experience with accidental dural puncture and post-dural puncture headache in a tertiary obstetric anaesthesia department. Int J Obstet Anesth. 2008 Oct;17(4):329-35. doi: 10.1016/j.ijoa.2007.04.009. Epub 2008 Aug 8.
PubMed 18691871Iwase Y, Suzuki M, Bito H. A case report of intracranial hemorrhage after spinal anesthesia. JA Clin Rep. 2017;3(1):11. doi: 10.1186/s40981-017-0081-x. Epub 2017 Mar 9.
PubMed 29492450Orbach-Zinger S, Eidelman LA, Livne MY, Matkovski O, Mangoubi E, Borovich A, Wazwaz SA, Ioscovich A, Zekry ZHB, Ariche K, Weiniger CF. Long-term psychological and physical outcomes of women after postdural puncture headache: A retrospective, cohort study. Eur J Anaesthesiol. 2021 Feb 1;38(2):130-137. doi: 10.1097/EJA.0000000000001297.
PubMed 32858584Moore AR, Wieczorek PM, Carvalho JCA. Association Between Post-Dural Puncture Headache After Neuraxial Anesthesia in Childbirth and Intracranial Subdural Hematoma. JAMA Neurol. 2020 Jan 1;77(1):65-72. doi: 10.1001/jamaneurol.2019.2995.
PubMed 31524925Arevalo-Rodriguez I, Ciapponi A, Roque i Figuls M, Munoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009199. doi: 10.1002/14651858.CD009199.pub3.
PubMed 26950232Uppal V, Russell R, Sondekoppam RV, Ansari J, Baber Z, Chen Y, DelPizzo K, Dirzu DS, Kalagara H, Kissoon NR, Kranz PG, Leffert L, Lim G, Lobo C, Lucas DN, Moka E, Rodriguez SE, Sehmbi H, Vallejo MC, Volk T, Narouze S. Evidence-based clinical practice guidelines on postdural puncture headache: a consensus report from a multisociety international working group. Reg Anesth Pain Med. 2024 Jul 8;49(7):471-501. doi: 10.1136/rapm-2023-104817.
PubMed 37582578
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Hydroxyethyl Starch Administration for Prevention of Post-Dural Puncture Headache in Parturients: A Multi-center Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07914790
- Acronym / sponsor ID
- 2026R0413-0002
- Conditions
- Parturients, Accidental Puncture of Dura During Anaesthesia, Epidural Filling, Hydroxyethyl Starch, Post-dural Puncture Headache
- Keywords
- Parturients, Accidental Dural Puncture, Epidural Filling with Hydroxyethyl Starch, Post-dural Puncture Headache
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Ningxia Maternal and Child Health Hospital, Beijing Haidian Maternal and Child Health Hospital, Taiyuan central hospital
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural hydroxyethyl starch group | – | Drug: Epidural hydroxyethyl starchFor 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. |
| Non epidural hydroxyethyl starch group | – | Drug: No epidural hydroxyethyl starchFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age ≥18 years.
- Have experienced accidental dural puncture (ADP) during epidural labor analgesia or neuraxial anesthesia for cesarean delivery.
Key exclusion criteria (9 listed)
- Age <18 years.
- ASA physical status ≥IV.
- Cesarean delivery under general anesthesia.
- Preoperative inability to communicate due to intellectual or language impairment.
- Pre-existing cerebrovascular disease, migraine, or chronic headache.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural hydroxyethyl starchAlso: Epidural filling with hydroxyethyl starchFor 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 group |
| No epidural hydroxyethyl starchAlso: No epidural filling with hydroxyethyl starchFor 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 | Non epidural hydroxyethyl starch group |
Primary outcome
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.
2 secondary outcomes
Duration of post-dural puncture headache (PDPH)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 9512843Berger CW, Crosby ET, Grodecki W. North American survey of the management of dural puncture occurring during labour epidural analgesia. Can J Anaesth. 1998 Feb;45(2):110-4. doi: 10.1007/BF03013247.
- Background: PubMed 39935247Cohen S, Greenberger C, Aptekman B, Rabkin V, Weiniger CF. Incidence and management of accidental dural puncture and postdural puncture headache in parturients: Retrospective database study. Eur J Anaesthesiol. 2025 Jun 1;42(6):492-499. doi: 10.1097/EJA.0000000000002130. Epub 2025 Feb 12.
- Background: PubMed 15321604Paech M, Banks S, Gurrin L. An audit of accidental dural puncture during epidural insertion of a Tuohy needle in obstetric patients. Int J Obstet Anesth. 2001 Jul;10(3):162-7. doi: 10.1054/ijoa.2000.0825.
- Background: PubMed 31335402Guglielminotti J, Landau R, Li G. Major Neurologic Complications Associated With Postdural Puncture Headache in Obstetrics: A Retrospective Cohort Study. Anesth Analg. 2019 Nov;129(5):1328-1336. doi: 10.1213/ANE.0000000000004336.
- Background: PubMed 33021807Makito K, Matsui H, Fushimi K, Yasunaga H. Incidences and risk factors for post--dural puncture headache after neuraxial anaesthesia: A national inpatient database study in Japan. Anaesth Intensive Care. 2020 Sep;48(5):381-388. doi: 10.1177/0310057X20949555. Epub 2020 Oct 6.
- Background: PubMed 28131118Gaiser RR. Postdural Puncture Headache: An Evidence-Based Approach. Anesthesiol Clin. 2017 Mar;35(1):157-167. doi: 10.1016/j.anclin.2016.09.013.
- Background: PubMed 37581893Uppal V, Russell R, Sondekoppam R, Ansari J, Baber Z, Chen Y, DelPizzo K, Dirzu DS, Kalagara H, Kissoon NR, Kranz PG, Leffert L, Lim G, Lobo CA, Lucas DN, Moka E, Rodriguez SE, Sehmbi H, Vallejo MC, Volk T, Narouze S. Consensus Practice Guidelines on Postdural Puncture Headache From a Multisociety, International Working Group: A Summary Report. JAMA Netw Open. 2023 Aug 1;6(8):e2325387. doi: 10.1001/jamanetworkopen.2023.25387.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 33725362Binyamin Y, Heesen P, Orbach-Zinger S, Gozal Y, Halimi D, Frenkel A, Ioscovich A. Chronic pain in parturients with an accidental dural puncture: A case-controlled prospective observational study. Acta Anaesthesiol Scand. 2021 Aug;65(7):959-966. doi: 10.1111/aas.13816. Epub 2021 Mar 24.
- Background: PubMed 18691871Van de Velde M, Schepers R, Berends N, Vandermeersch E, De Buck F. Ten years of experience with accidental dural puncture and post-dural puncture headache in a tertiary obstetric anaesthesia department. Int J Obstet Anesth. 2008 Oct;17(4):329-35. doi: 10.1016/j.ijoa.2007.04.009. Epub 2008 Aug 8.
- Background: PubMed 29492450Iwase Y, Suzuki M, Bito H. A case report of intracranial hemorrhage after spinal anesthesia. JA Clin Rep. 2017;3(1):11. doi: 10.1186/s40981-017-0081-x. Epub 2017 Mar 9.
- Background: PubMed 32858584Orbach-Zinger S, Eidelman LA, Livne MY, Matkovski O, Mangoubi E, Borovich A, Wazwaz SA, Ioscovich A, Zekry ZHB, Ariche K, Weiniger CF. Long-term psychological and physical outcomes of women after postdural puncture headache: A retrospective, cohort study. Eur J Anaesthesiol. 2021 Feb 1;38(2):130-137. doi: 10.1097/EJA.0000000000001297.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parturients and Accidental Puncture of Dura During Anaesthesia, run by Peking University First Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Yu Geng, MD (86 10 83572460, gengzhiyu2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-dural puncture headache (PDPH) within 7 days. (time frame: Up to 7 days after accidental dural puncture.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07914790, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.