Cesarean Delivery Affecting NewbornPhase 4NEO-FETNCT06921473
Ephedrine Versus Norepinephrine and Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia
A Phase 4 study testing Norepinephrine and Ephedrine in people with Cesarean Delivery Affecting Newborn and Acidosis, run by mehmet özkılıç at 1 site in Turkey (Türkiye).
Trial summary
This study compares ephedrine and norepinephrine for the treatment of low blood pressure (hypotension) that may occur during cesarean delivery under spinal anesthesia. Maternal hypotension can reduce uteroplacental blood flow and may affect fetal well-being. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Delivery Affecting Newborn, Acidosis, Maternal Hypotension
- What is being tested?
- Norepinephrine and Ephedrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Hypertensive disorders of pregnancy
- Known systemic disease
- Multiple gestation
- Emergency cesarean delivery
- Contraindication to spinal anesthesia
- Known allergy to the study medications
Show all 10Show fewer
- Pre-diagnosed fetal growth restriction identified using standardized growth curves and pathological Doppler findings
- Suspected fetal distress
- Oligohydramnios
- Known congenital fetal anomalies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBÜ Gazi Yaşargil Eğitim ve Araştırma Hastanesi
Diyarbakır, 21070
About this study
Official title: Comparative Effects of Ephedrine and Norepinephrine on Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia: A Randomized Double-Blind Study
This study compares ephedrine and norepinephrine for the treatment of low blood pressure (hypotension) that may occur during cesarean delivery under spinal anesthesia. Maternal hypotension can reduce uteroplacental blood flow and may affect fetal well-being. Both medications are commonly used to restore blood pressure. The primary aim of this study is to compare their effects on neonatal acid-base status, assessed by umbilical arterial pH measured immediately after birth. Secondary outcomes include other umbilical arterial blood gas parameters, maternal blood pressure and heart rate, vasopressor requirements, maternal adverse events, and neonatal Apgar scores.
Read the detailed description
This is a prospective, randomized, double-blind, controlled clinical trial designed to compare the effects of ephedrine and norepinephrine on fetal acid-base status during elective cesarean delivery under spinal anesthesia. Maternal hypotension is a common complication of spinal anesthesia and may reduce uteroplacental perfusion. Ephedrine and norepinephrine are both used to restore maternal blood pressure, but their comparative effects on fetal acid-base balance and maternal hemodynamics remain incompletely defined.
The primary aim of the study is to compare umbilical arterial pH between patients treated with ephedrine and those treated with norepinephrine for postspinal hypotension. Secondary outcomes include other umbilical arterial blood gas parameters, including pCO₂, bicarbonate, base excess, and lactate; the incidence of neonatal acidosis defined as umbilical arterial pH <7.20; Apgar scores at 1 and 5 minutes; maternal systolic blood pressure and heart rate; vasopressor requirements; and maternal adverse events.
A total of 155 parturients were randomized in a 1:1 ratio before spinal anesthesia. Because the study drugs were administered only when postspinal hypotension occurred, the analysis population consisted of randomized participants who developed hypotension and received the allocated vasopressor. This resulted in 102 participants in the final analysis population, including 50 in the ephedrine group and 52 in the norepinephrine group.
All randomized participants underwent a standardized spinal anesthesia protocol. Postspinal hypotension was treated with repeated intravenous boluses of either ephedrine 5 mg or norepinephrine 5 µg according to the allocated treatment arm. The study was designed to compare fetal acid-base effects and maternal hemodynamic responses associated with these two vasopressor strategies.
- Being tested
- Norepinephrine, Ephedrine
- Keywords
- Ephedrine, Norepinephrine, Postspinal Hypotension, Umbilical Arterial pH, Fetal Acid-Base Status, Cesarean Delivery
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Also called Steradin®
Intravenous norepinephrine 5 µg bolus administered for the treatment of postspinal hypotension during elective cesarean delivery. Additional 5 µg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved.
EphedrineDrug
Also called Ephedrine hydrochloride
Intravenous ephedrine 5 mg bolus administered for the treatment of postspinal hypotension during elective cesarean delivery. Additional 5 mg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved.
| Study group | Role | What they receive |
|---|---|---|
| Ephedrine Group | Active comparator | Participants allocated to this group received intravenous ephedrine 5 mg boluses for the treatment of postspinal hypotension. Additional 5 mg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved. Receives: Drug: Ephedrine |
| Norepinephrine Group | Experimental | Participants allocated to this group received intravenous norepinephrine 5 µg boluses for the treatment of postspinal hypotension. Additional 5 µg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved. Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical arterial pH
Umbilical arterial pH measured immediately after delivery from an arterial blood sample obtained from a double-clamped segment of the umbilical cord and analyzed within 5 minutes using a blood gas analyzer.
Measured: Immediately after delivery
Secondary outcomes (3)
Maternal hypotension
Postspinal hypotension was defined as a decrease in systolic blood pressure to less than 80% of the baseline value. The number and duration of hypotensive episodes were recorded.
Measured: From spinal anesthesia until delivery
Incidence of neonatal acidosis (UA pH <7.20)
Incidence of neonatal acidosis, defined as an umbilical arterial pH <7.20, determined from an umbilical arterial blood sample obtained immediately after delivery and analyzed using a point-of-care blood gas analyzer.
Measured: Immediately after delivery
Maternal heart rate response
Maternal heart rate was recorded after spinal anesthesia and during periods requiring vasopressor administration. Temporal heart rate changes and the occurrence of tachycardia were recorded.
Measured: From spinal anesthesia until delivery / during surger
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Delivery Affecting NewbornStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, double-blind, two-arm parallel assignment study. Participants are allocated in a 1:1 ratio to either the ephedrine or norepinephrine group before spinal anesthesia. The allocated vasopressor is administered intravenously only if postspinal hypotension develops. Randomization is performed using a computer-generated block randomization sequence with varying block sizes. Study medications are prepared in visually identical syringes by an independent investigator, and participants, treating anesthesiologists, and outcome assessors remain blinded to group allocation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- mehmet özkılıç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mehmet özkılıç, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD, Principal investigator, Gazi Yaşargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921473
- Sponsor's protocol ID
- GYEAH-OB-NE-EF-001
- Acronym
- NEO-FET
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because data sharing was not included in the approved study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Ephedrine and Norepinephrine on Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia: A Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT06921473
- Acronym / sponsor ID
- NEO-FET / GYEAH-OB-NE-EF-001
- Keywords
- Ephedrine, Norepinephrine, Postspinal Hypotension, Umbilical Arterial pH, Fetal Acid-Base Status, Cesarean Delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- mehmet özkılıçUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 10 Apr 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.
This study compares ephedrine and norepinephrine for the treatment of low blood pressure (hypotension) that may occur during cesarean delivery under spinal anesthesia. Maternal hypotension can reduce uteroplacental blood flow and may affect fetal well-being. Both medications are commonly used to restore blood pressure. The primary aim of this study is to compare their effects on neonatal acid-base status, assessed by umbilical arterial pH measured immediately after birth. Secondary outcomes include other umbilical arterial blood gas parameters, maternal blood pressure and heart rate, vasopressor requirements, maternal adverse events, and neonatal Apgar scores.
Detailed description
This is a prospective, randomized, double-blind, controlled clinical trial designed to compare the effects of ephedrine and norepinephrine on fetal acid-base status during elective cesarean delivery under spinal anesthesia. Maternal hypotension is a common complication of spinal anesthesia and may reduce uteroplacental perfusion. Ephedrine and norepinephrine are both used to restore maternal blood pressure, but their comparative effects on fetal acid-base balance and maternal hemodynamics remain incompletely defined.
The primary aim of the study is to compare umbilical arterial pH between patients treated with ephedrine and those treated with norepinephrine for postspinal hypotension. Secondary outcomes include other umbilical arterial blood gas parameters, including pCO₂, bicarbonate, base excess, and lactate; the incidence of neonatal acidosis defined as umbilical arterial pH <7.20; Apgar scores at 1 and 5 minutes; maternal systolic blood pressure and heart rate; vasopressor requirements; and maternal adverse events.
A total of 155 parturients were randomized in a 1:1 ratio before spinal anesthesia. Because the study drugs were administered only when postspinal hypotension occurred, the analysis population consisted of randomized participants who developed hypotension and received the allocated vasopressor. This resulted in 102 participants in the final analysis population, including 50 in the ephedrine group and 52 in the norepinephrine group.
All randomized participants underwent a standardized spinal anesthesia protocol. Postspinal hypotension was treated with repeated intravenous boluses of either ephedrine 5 mg or norepinephrine 5 µg according to the allocated treatment arm. The study was designed to compare fetal acid-base effects and maternal hemodynamic responses associated with these two vasopressor strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, double-blind, two-arm parallel assignment study. Participants are allocated in a 1:1 ratio to either the ephedrine or norepinephrine group before spinal anesthesia. The allocated vasopressor is administered intravenously only if postspinal hypotension develops. Randomization is performed using a computer-generated block randomization sequence with varying block sizes. Study medications are prepared in visually identical syringes by an independent investigator, and participants, treating anesthesiologists, and outcome assessors remain blinded to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Ephedrine Group | Active comparator | Drug: EphedrineParticipants allocated to this group received intravenous ephedrine 5 mg boluses for the treatment of postspinal hypotension. Additional 5 mg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved. |
| Norepinephrine Group | Experimental | Drug: NorepinephrineParticipants allocated to this group received intravenous norepinephrine 5 µg boluses for the treatment of postspinal hypotension. Additional 5 µg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Hypertensive disorders of pregnancy
- Known systemic disease
- Multiple gestation
- Emergency cesarean delivery
- Contraindication to spinal anesthesia
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 |
|---|---|---|
| NorepinephrineAlso: Steradin®Intravenous norepinephrine 5 µg bolus administered for the treatment of postspinal hypotension during elective cesarean delivery. Additional 5 µg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved. | Drug | Norepinephrine Group |
| EphedrineAlso: Ephedrine hydrochlorideIntravenous ephedrine 5 mg bolus administered for the treatment of postspinal hypotension during elective cesarean delivery. Additional 5 mg boluses were administered at 1-minute intervals as needed until the predefined blood pressure target was achieved. | Drug | Ephedrine Group |
Primary outcome
Umbilical arterial pH
Time frame: Immediately after delivery
Umbilical arterial pH measured immediately after delivery from an arterial blood sample obtained from a double-clamped segment of the umbilical cord and analyzed within 5 minutes using a blood gas analyzer.
3 secondary outcomes
Maternal hypotension
Time frame: From spinal anesthesia until delivery
Incidence of neonatal acidosis (UA pH <7.20)
Time frame: Immediately after delivery
Maternal heart rate response
Time frame: From spinal anesthesia until delivery / during surger
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared because data sharing was not included in the approved study protocol.
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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. This study is not recruiting at the moment.
Mehmet ÖZKILIÇ, Anesthesiology and Intensive Care Specialist, MD principal investigator
Gazi Yaşargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine and Ephedrine in people with Cesarean Delivery Affecting Newborn and Acidosis, run by mehmet özkılıç at 1 site in Turkey (Türkiye).
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 0 inclusion and 10 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: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical arterial pH (time frame: Immediately after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.