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A multicenter, non inferiority, controlled study on the effects of prophylactic infusion of equivalent doses of phenylephrine and norepinephrine on maternal and infant outcomes after cesarean section under spinal anesthesia

A multicenter, non inferiority, controlled study on the effects of prophylactic infusion of equivalent doses of phenylephrine and norepinephrine on maternal and infant outcomes after cesarean section under spinal anesthesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087985
Enrollment
Unknown
Registered
2024-08-08
Start date
2024-08-08
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

spinal anaesthesia-induced hypotension during cesarean section

Interventions

Group Phenylephrine (Group PE):Intravenous pump Phenylephrine

Sponsors

Wenling Maternal and Child Health Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: ASA I - II, single fetus (gestational age =37 weeks) elective cesarean section.

Exclusion criteria

Exclusion criteria: ASA=?, SBP 140mmHg, height 170 cm, age 40 years old, obese (body mass index =35kg/m²), allergic to norepinephrine or phenylephrine, gestational hypertension, diabetes mellitus, cardiovascular disease, coagulation disorders, thrombocytopenia, contraindications of intraspinal anesthesia, placenta previa, rupture of fetal membrane, fetal congenital malformation, etc.

Design outcomes

Primary

MeasureTime frame
Umbilical artery blood pH;Maternal hemodynamics (hypertension and heart rate) within 15 minutes after spinal anesthesia;

Secondary

MeasureTime frame
Other results of fetal umbilical artery blood gas analysis and umbilical vein blood gas analysis;Apgar score 1 and 5 minutes after delivery;Total consumption of vasoactive drugs before delivery, etc.;Incidence of maternal severe hypotension, reactive hypertension, bradycardia, nausea, vomiting, etc.;The incidence of maternal hypotension from spinal anesthesia to fetal delivery;

Countries

China

Contacts

Public ContactZhimin Sheng

Wenling Maternal and Child Health Care Hospital

108422045@qq.com+86 136 0668 6500

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026