Maternal HypotensionNCT07272018
Maternal and Fetal Clinical Significance of Hypotension Following Labor Epidural Analgesia
An observational study of Maternal Hypotension and Labor Epidural Analgesia, run by The Chaim Sheba Medical Center.
Trial summary
The goal of this study is to learn how often blood pressure drops after an epidural for labor and how these drops may affect the parent and the baby. The study focuses on adults who give birth at term and choose to receive an epidural for pain relief. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Hypotension, Labor Epidural Analgesia, Fetal Heart Rate Abnormalities
- What is being tested?
- Epidural Analgesia (Standard Clinical Care)
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Mar 2026
- How long will I take part?
- 7 Days
- 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: Laboring adults who receive epidural analgesia for pain relief at the labor and delivery unit of Sheba Medical Center, a large tertiary hospital in Israel. Participants represent people giving birth at term who choose epidural analgesia as part of their routine clinical care.
Who may be able to join
- 18 years of age or older
- 37 weeks pregnant or more (term pregnancy)
- in labor and choose to receive an epidural for pain relief
- giving birth at Sheba Medical Center
Who cannot join
- patients with a heart condition that requires special blood pressure management
- medical conditions that prevent safe monitoring of blood pressure
- missing or incomplete medical record data needed for the study
- patient who do not receive an epidural during labor
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Incidence and Clinical Significance of Maternal Hypotension After Labor Epidural Analgesia and Its Effects on Fetal Well-Being
The goal of this study is to learn how often blood pressure drops after an epidural for labor and how these drops may affect the parent and the baby. The study focuses on adults who give birth at term and choose to receive an epidural for pain relief.
The main questions the study aims to answer are:
Read more
How often does maternal blood pressure fall within 30 minutes after the epidural? When blood pressure falls, how often do participants need treatments such as fluids or medicines that raise blood pressure? Do changes in the baby's heart rate happen during this time, and do they need treatment? Are certain parent or labor factors linked to a higher chance of blood pressure drops? How often does an urgent cesarean delivery happen because of maternal low blood pressure or concerning fetal heart rate changes soon after the epidural?
Participants will not be asked to do anything different from usual care. Researchers will:
Review routine vital signs recorded before and after the epidural Review treatments given, such as IV fluids or blood-pressure-raising medicines Review the baby's heart-rate monitoring Record delivery information, including whether an urgent cesarean was needed This study does not change clinical care in any way. It uses information already collected during standard labor and delivery.
- Being tested
- Epidural Analgesia (Standard Clinical Care)
- Keywords
- Labor Epidural Analgesia, Post-Epidural Hypotension, Maternal Hypotension, Fetal Heart Rate Abnormalities, Non-Reassuring Fetal Heart Rate, Obstetric Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Analgesia (Standard Clinical Care)Other
Participants receive epidural analgesia for labor pain relief as part of routine clinical care at Sheba Medical Center. The epidural involves placement of an epidural catheter, a test dose, and a loading dose of local anesthetic according to hospital protocol. The study does not change how the epidural is performed. Researchers only observe maternal blood pressure and fetal heart rate after epidural placement.
| Study group | Role | What they receive |
|---|---|---|
| Laboring Participants Receiving Epidural Analgesia | This cohort includes adults in labor at Sheba Medical Center who choose to receive epidural analgesia for pain relief. All participants receive standard clinical care. Researchers will observe maternal blood pressure and fetal heart rate changes during the first 30 minutes after the epidural. Receives: Other: Epidural Analgesia (Standard Clinical Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and relative number of patients with any MAP (mean arterial pressure) < 65 mmHg
Hypotension after epidural placement
Measured: First 30 minutes after epidural placement
Secondary outcomes (11)
Absolute and relative number of patients with any MAP (mean arterial pressure) < 60, 55 mmHg
Hypotension after epidural placement
Measured: First 30 minutes after epidural placement
Absolute and relative number of patients with any SBP (systolic blood pressure) < 90, 85, 80 mmHg
Hypotension after epidural placement
Measured: First 30 minutes after epidural placement
Incidence of postepidural hypotension defined as ≥20% MAP (mean arterial pressure) drop
Hypotension after epidural placement
Measured: First 30 minutes after epidural placement
Absolute and relative number of patients with ≥20% SBP (systolic blood pressure) drop
Hypotension after epidural placement
Measured: First 30 minutes after epidural placement
Time-to-treatment of Hypotension (minutes)
The time interval between epidural placement and the treatment of hypotension by clinical staff
Measured: First 30 minutes after epidural placement
Area under a MAP of 65, 60, 55 mmHg [mmHg x min]
Measured: First 30 minutes after epidural placement
Absolute and relative number of patients with symptoms due to hypotension
Weakness, lightheadedness, fainting, dizziness, nausea, vomiting
Measured: First 30 minutes after epidural placement
Absolute and relative number of patients with NRFHR (Non-reassuring fetal heart rate)
Measured: First 30 minutes after epidural placement
Absolute and relative number of patients who received fluid bolus
Measured: First 30 minutes after epidural placement
Absolute and relative number of patients who received vasopressor
Phenylephrine, ephedrine
Measured: First 30 minutes after epidural placement
Absolute and relative numbers of patients who underwent urgent Cesarean section (Category 1 or 2 urgency) due to hypotension or NRFHR (non-reassuring fetal heart rate)
Measured: First 30 minutes after epidural placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maternal HypotensionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- The Chaim Sheba Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maxim Glebov, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272018
- Sponsor's protocol ID
- SMC-2210-25
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ralston DH, Shnider SM. The fetal and neonatal effects of regional anesthesia in obstetrics. Anesthesiology. 1978 Jan;48(1):34-64. doi: 10.1097/00000542-197801000-00007. No abstract available.
PubMed 339784Ghidini A, Vanasche K, Cacace A, Cacace M, Fumagalli S, Locatelli A. Side effects from epidural analgesia in laboring women and risk of cesarean delivery. AJOG Glob Rep. 2023 Dec 12;4(1):100297. doi: 10.1016/j.xagr.2023.100297. eCollection 2024 Feb.
PubMed 38283322Paech MJ, Godkin R, Webster S. Complications of obstetric epidural analgesia and anaesthesia: a prospective analysis of 10,995 cases. Int J Obstet Anesth. 1998 Jan;7(1):5-11. doi: 10.1016/s0959-289x(98)80021-6.
PubMed 15321239Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
PubMed 29781504
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Clinical Significance of Maternal Hypotension After Labor Epidural Analgesia and Its Effects on Fetal Well-Being
- ClinicalTrials.gov ID
- NCT07272018
- Acronym / sponsor ID
- SMC-2210-25
- Keywords
- Labor Epidural Analgesia, Post-Epidural Hypotension, Maternal Hypotension, Fetal Heart Rate Abnormalities, Non-Reassuring Fetal Heart Rate, Obstetric Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- The Chaim Sheba Medical CenterUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 9 Dec 2025 (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 goal of this study is to learn how often blood pressure drops after an epidural for labor and how these drops may affect the parent and the baby. The study focuses on adults who give birth at term and choose to receive an epidural for pain relief.
The main questions the study aims to answer are:
How often does maternal blood pressure fall within 30 minutes after the epidural? When blood pressure falls, how often do participants need treatments such as fluids or medicines that raise blood pressure? Do changes in the baby's heart rate happen during this time, and do they need treatment? Are certain parent or labor factors linked to a higher chance of blood pressure drops? How often does an urgent cesarean delivery happen because of maternal low blood pressure or concerning fetal heart rate changes soon after the epidural?
Participants will not be asked to do anything different from usual care. Researchers will:
Review routine vital signs recorded before and after the epidural Review treatments given, such as IV fluids or blood-pressure-raising medicines Review the baby's heart-rate monitoring Record delivery information, including whether an urgent cesarean was needed This study does not change clinical care in any way. It uses information already collected during standard labor and delivery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboring Participants Receiving Epidural Analgesia | – | Other: Epidural Analgesia (Standard Clinical Care)This cohort includes adults in labor at Sheba Medical Center who choose to receive epidural analgesia for pain relief. All participants receive standard clinical care. Researchers will observe maternal blood pressure and fetal heart rate changes during the first 30 minutes after the epidural. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Laboring adults who receive epidural analgesia for pain relief at the labor and delivery unit of Sheba Medical Center, a large tertiary hospital in Israel. Participants represent people giving birth at term who choose epidural analgesia as part of their routine clinical care.
Key inclusion criteria (4 listed)
- 18 years of age or older
- 37 weeks pregnant or more (term pregnancy)
- in labor and choose to receive an epidural for pain relief
- giving birth at Sheba Medical Center
Key exclusion criteria (4 listed)
- patients with a heart condition that requires special blood pressure management
- medical conditions that prevent safe monitoring of blood pressure
- missing or incomplete medical record data needed for the study
- patient who do not receive an epidural during labor
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 Analgesia (Standard Clinical Care)Participants receive epidural analgesia for labor pain relief as part of routine clinical care at Sheba Medical Center. The epidural involves placement of an epidural catheter, a test dose, and a loading dose of local anesthetic according to hospital protocol. The study does not change how the epidural is performed. Researchers only observe maternal blood pressure and fetal heart rate after epidural placement. | Other | Laboring Participants Receiving Epidural Analgesia |
Primary outcome
Absolute and relative number of patients with any MAP (mean arterial pressure) < 65 mmHg
Time frame: First 30 minutes after epidural placement
Hypotension after epidural placement
11 secondary outcomes
Absolute and relative number of patients with any MAP (mean arterial pressure) < 60, 55 mmHg
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients with any SBP (systolic blood pressure) < 90, 85, 80 mmHg
Time frame: First 30 minutes after epidural placement
Incidence of postepidural hypotension defined as ≥20% MAP (mean arterial pressure) drop
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients with ≥20% SBP (systolic blood pressure) drop
Time frame: First 30 minutes after epidural placement
Time-to-treatment of Hypotension (minutes)
Time frame: First 30 minutes after epidural placement
Area under a MAP of 65, 60, 55 mmHg [mmHg x min]
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients with symptoms due to hypotension
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients with NRFHR (Non-reassuring fetal heart rate)
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients who received fluid bolus
Time frame: First 30 minutes after epidural placement
Absolute and relative number of patients who received vasopressor
Time frame: First 30 minutes after epidural placement
Absolute and relative numbers of patients who underwent urgent Cesarean section (Category 1 or 2 urgency) due to hypotension or NRFHR (non-reassuring fetal heart rate)
Time frame: First 30 minutes after epidural placement
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 9 Dec 2025.
- Results publication: PubMed 339784Ralston DH, Shnider SM. The fetal and neonatal effects of regional anesthesia in obstetrics. Anesthesiology. 1978 Jan;48(1):34-64. doi: 10.1097/00000542-197801000-00007. No abstract available.
- Results publication: PubMed 38283322Ghidini A, Vanasche K, Cacace A, Cacace M, Fumagalli S, Locatelli A. Side effects from epidural analgesia in laboring women and risk of cesarean delivery. AJOG Glob Rep. 2023 Dec 12;4(1):100297. doi: 10.1016/j.xagr.2023.100297. eCollection 2024 Feb.
- Results publication: PubMed 15321239Paech MJ, Godkin R, Webster S. Complications of obstetric epidural analgesia and anaesthesia: a prospective analysis of 10,995 cases. Int J Obstet Anesth. 1998 Jan;7(1):5-11. doi: 10.1016/s0959-289x(98)80021-6.
- Results publication: PubMed 29781504Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
- Individual participant dataSharing planned: No
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ED90 of Norepinephrine and Phenylephrine Infusion in Patients of Advanced Maternal Age
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Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Hypotension and Labor Epidural Analgesia, run by The Chaim Sheba Medical Center.
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 4 inclusion and 4 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Maxim Glebov, Dr (+972585893324, hlebau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute and relative number of patients with any MAP (mean arterial pressure) < 65 mmHg (time frame: First 30 minutes after epidural placement). 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 NCT07272018, which also lists 4 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 9 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.