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To find the adequate dose of carbetocin during cesarean surgery in patients of preeclampsia, with and without magnesium sulfate therapy

Minimum effective dose of carbetocin during cesarean delivery in patients of preeclampsia with and without magnesium sulfate therapy: A sequential allocation dose-response study - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066205
Enrollment
80
Registered
2024-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Preeclamptic pregnant patients with magnesium sulfate therapy undergoing cesarean delivery using spinal block: Titrated dose of carbetocin according to sequential allocation design
intravenous at time of fetal delivery, dose of 20 -140 microgram depending on blinded allocation Control Intervention1: Preeclamptic pregnant patients without magnesium sulfate therapy undergoing cesa
intravenous at time of fetal delivery, dose of 20 to 140 microgram depending on blinded allocation

Sponsors

University College of Medical Sciences and GTBH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Non-laboring parturients, with preeclampsia (with or without magnesium sulfate therapy scheduled for cesarean delivery under spinal block

Exclusion criteria

Exclusion criteria: Patient refusal, presence of active labor (defined as cervical dilatation of 4 cm or more), preoperative use of oxytocin, or other conditions predisposing to PPH i.e., history of previous PPH, chorioamnionitis, macrosomia, more than two previous uterine surgery, previous history of bleeding disorders, and presence of abnormal placentation/uterine fibroid; as well as use of general anesthesia

Design outcomes

Primary

MeasureTime frame
The ED90 dose (dose effective in 90% population) for satisfactory uterine tone as judged by the obstetricianTimepoint: 2 minutes after carbetocin injection, and then till end of surgery.

Secondary

MeasureTime frame
Carbetocin associated side effects like hypotension, tachycardiaTimepoint: From administration of carbetocin to 10 minutes later.

Countries

India

Contacts

Public ContactDr Rabinsan S

University College of Medical Sciences and GTB Hospital

drashatyagi@gmail.com22692415

Outcome results

None listed

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