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Mie elective Caesarean section Anesthesia trial (MCA trial)

A Randomized, Parallel Group Study of the Association of Maternal Blood Pressure Changes and Neonatal Laboratory Findings with Timing of Phenylephrine Hydrochloride Use in Elective Cesarean Section (MCA trial)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041230178
Enrollment
70
Registered
2024-03-28
Start date
2024-03-28
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

hypotension hypotension, elective caesarean section, non-reassuring fetal status

Interventions

In the study treatment group, administration of phenylephrine hydrochloride (0.5 mcg/kg/min) is initiated prior to spinal anesthesia. The administration of phenylephrine hydrochloride prior to spinal
D02.033.100.291.617, D02.092.063.291.617
Prophylactic vasopressor administration

Sponsors

Magawa Shoichi
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Age 18 years or older 2) Elective cesarean section after 37 weeks of pregnancy 3) Singleton pregnancy 4) Written consent has been obtained from the patient

Exclusion criteria

Exclusion criteria: Patients with hypertension systolic blood pressure over140 mmHg or diastolic blood pressure over90 mmHg) at the time of registration Patients with cardiac, vascular, renal, or coagulation disorders Patients with pregnancy-related complications, hypertension, gestational hypertension, chronic kidney disease, etc. Those with either amniotic fluid abnormalities or fetal growth retardation Those with fetal malformations that affect umbilical artery blood gas analysis and neonatal respiratory support after birth Those with drug allergy to phenylephrine hydrochloride Those who are judged by the principal investigator/associate investigator to be inappropriate as subjects for this clinical trial

Design outcomes

Primary

MeasureTime frame
Maternal blood pressure variability from spinal anesthesia to delivery of the infant (evaluation period)

Secondary

MeasureTime frame
Group differences in maternal and neonatal background maternal-related information, age, delivery week, complications, height, pre-pregnancy weight, weight at delivery, number of births, neonatal-related information, sex, APGAR Score, 1 min value 5 min value, height, weight Blood pressure related parameters Number of occurrence of hypotension measured by brachial manchette, maximum systolic blood pressure, minimum systolic blood pressure, maximum diastolic blood pressure, minimum systolic blood pressure, maternal blood pressure changes during the observation period maximum systolic blood pressure manus minimum systolic blood pressure, maximum diastolic blood pressure mainus minimum diastolic blood pressure Occurrence of hypotension measured by CLEARSIGHT, maximum systolic blood pressure, minimum systolic blood pressure, maximum diastolic blood pressure, minimum systolic blood pressure, course of maternal cardiac output, and changes in maternal blood pressure during the observation period maximum systolic blood pressure mainus minimum systolic blood pressure maximum diastolic blood pressure mainus minimum diastolic blood pressure Neonatal effects: umbilical cord blood gas analysis, pH, Base Ecess, pCO2, pO2, neonatal blood glucose,after birth, Neonatal blood glucose,from blood tests in the NICU after birth, frequency of neonatal respiratory support needs,for respiratory support required after postnatal resuscitation, NICU admission, and NICU admission. initial blood test findings after admission to the NICU, blood gas analysis, Placental weight Total dose of phenylephrine hydrochloride, mg; from the start of lumbar anesthesia to the delivery of the infant, and from the start of lumbar anesthesia to the end of surgery

Contacts

Public ContactShoichi Magawa

Mie university hospital

crsc-muh@med.mie-u.ac.jp+81-59-232-1111

Outcome results

None listed

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