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A Randomized, Assigned, Controlled Trial of Phenylephrine Alone versus Phenylephrine and Pre-Spinal Anesthesia Infusion Load Combination Blood Pressure Maintenance During Spinal Anesthesia in Pregnant Women Undergoing Scheduled Cesarean Section

A Randomized, Assigned, Controlled Trial of Phenylephrine Alone versus Phenylephrine and Pre-Spinal Anesthesia Infusion Load Combination Blood Pressure Maintenance During Spinal Anesthesia in Pregnant Women Undergoing Scheduled Cesarean Section

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041240008
Enrollment
70
Registered
2024-04-08
Start date
2024-06-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients requiring cesarean section

Interventions

To compare the UApH of patients undergoing scheduled cesarean section under spinal cord with respect to intraoperative infusion in the group without infusion loading (group N) and the group that loads

Sponsors

Naruse Satoshi
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. who are scheduled to have an elective cesarean section performed under spinal cord and who will have the cesarean section after 37 weeks and 0 days of pregnancy 2. Patients with a singleton pregnancy. 3. who are between 18 and 45 years of age at the time of consent 4. who have given consent for this study by signing a consent form in person.

Exclusion criteria

Exclusion criteria: 1. those with any fetal abnormality, including fetal growth retardation 2. those with abnormal placental position 3. Patients with gestational hypertension 4. with cardiac disease (stenotic valve disease, aortic stenosis, angina pectoris), cerebrovascular disease (moyamoya disease, cerebral aneurysm, cerebral arteriovenous malformation), or Abnormal blood coagulation (PT-INR>1.2 or APTT>50), platelet count less than 100,000/microl 5. Patients with hypothyroidism 6. hypermagnesemia (serum magnesium concentration >2.7 mg/dl) 7. obese patients (BMI >30 before pregnancy) 8. who have undergone uterine surgery (including Cesarean section) more than twice. 9. other patients whom the principal investigator or subinvestigator determines are not appropriate to be included in this study.

Design outcomes

Primary

MeasureTime frame
Umbilical artery blood pH (UApH)

Secondary

MeasureTime frame
1.Clinical examination: umbilical artery and vein blood gas analysis, hemoglobin level (preoperative, day after surgery) 2.Intraoperative data: fluid volume until delivery, phenylephrine dose, ephedrine dose, Apgar score (1 min, 5 min), nausea and vomiting, blood loss (excluding amniotic fluid), urine volume, values obtained from Sterling SV, whether and to what extent the infant needs resuscitation (oxygen, CPAP, tracheal intubation, or more) 3.Postoperative data: presence or absence of NICU admission, indication for NICU admission, ObsQoR-10 on the morning following surgery, urine output by the morning following surgery, values obtained from Sterling SV, presence or absence of maternal postoperative complications and their details

Contacts

Public ContactSatoshi Naruse

Hamamatsu University Hospital

07483971@hama-med.ac.jp+81-53-435-2738

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026