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Comparison of oxytocin low-rate infusion versus oxytocin bolus for initiating uterine contraction during cesarean delivery: A randomized, controlled, non-inferiority trial

Comparison of oxytocin low-rate infusion versus oxytocin bolus for initiating uterine contraction during cesarean delivery: A randomized, controlled, non-inferiority trial

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221113003
Enrollment
160
Registered
2022-11-13
Start date
2022-10-31
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pregnancy undergoing for elective Cesarean delivery under spinal anesthesia oxytocin, oxytocin bolus, oxytocin infusion, uterine atony postpartum hemorrhage, Cesarean section, Cesarean delivery

Interventions

LRS 1,000 ml + oxytocin 20 IU drip 125 ml/h,Oxytocin bolus 5 IU
Active Comparator Drug,Active Comparator Drug
Low-rate oxytocin infusion 2.5 U/h,Oxytocin bolus 5 IU

Sponsors

Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnancy aged 18-40 years old, GA 37-42 weeks, ASA ll, singleton, scheduled undergoing elective Cesarean delivery under spinal anesthesia

Exclusion criteria

Exclusion criteria: Previous uterine surgery other than cesarean section, high risk of uterine atony (macrosomia, chorioamnionitis, polyhydramnios, uterine mass), high risk of postpartum hemorrhage (placenta previa or other placenta disorders, history of postpartum hemorrhage, coagulopathy, thrombocytopenia, pre-eclampsia)

Design outcomes

Primary

MeasureTime frame
Adequate uterine contraction at 3 minutes after fetal delivery percentage

Secondary

MeasureTime frame
Uterine tone at 3 minutes after fetal delivery percentage,Additional uterotonic agents after fetal delivery percentage,Estimate blood loss more than 500 ml after fetal delivery percentage,Mild adverse effects (nausea/vomiting, flushing, tachycardia) after fetal delivery until end of operation percentage,Severe adverse effects (hypotension, chest pain, EKG change) after fetal delivery until end of operation percentage

Countries

Thailand

Contacts

Public Contactwichuda pongsri

ANESKKU

wichuda.po@kkumail.com0801833091

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026