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A clinical trial to assess the effectiveness of calcium gluconate in prevention of weakness of uterus during lower segmental cesarean section delivery.

Efficacy of calcium gluconate in prevention of uterine atony during lower segmental cesarean section delivery: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055182
Enrollment
146
Registered
2023-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: O721- Other immediate postpartum hemorrhage Health Condition 2: O721- Other immediate postpartum hemorrhage

Interventions

Intervention1: INFUSION OF CALCIUM GLUCONATE: After umbilical cord is clamped, institutional standard regimen of oxytocin bolus is to be followed. At the same time, an infusion of 100ml study solution

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Pregnant female patients (18 to 45 years of age) 2)ASA physical class II or III 3)Emergency or elective LSCS with risk factors of PPH 4)Patients who have atleast two of the following established risk factors for uterine atony: intrapartum Cesarean delivery, failed operative vaginal delivery with forceps or vacuum, magnesium infusion, Chorioamnionitis, multiple gestation, Polyhydramnios, preterm delivery 40.

Exclusion criteria

Exclusion criteria: 1)Patient refusal to participate in the study 2)Maternal history of cardiac disease, arrhythmias, CAD 3)History of renal dysfunction with serum creatinine >1.0 mg/dL 4)Patients with placenta accreta 5)Treatment with digoxin within the last 2 weeks for a maternal or fetal indication 6)Treatment with a calcium channel blocker within 24 hours 7)General anaesthesia

Design outcomes

Primary

MeasureTime frame
The primary outcome variable of the study is the incidence of uterine atony and hence PPH in cesarean section (PPH is defined by a blood loss more than 1000ml, need for a second line uterotonic or any additional mechanical/surgical measures by surgeon to stop bleeding like bimanual compression, uterine packing, balloon tamponade, B lynch sutures, Cho sutures, Hayman sutures, uterine artery ligation or embolization or hysterectomy).Timepoint: 0 to 24 hours

Secondary

MeasureTime frame
The study intends to compare the amount of intraoperative blood loss, requirement of intravenous fluids and blood products if PPH occur in a case. The study also aims to compare intraoperative hemodynamic parameters between the two groups. Total units of oxytocin boluses and other uterotonics used in 24 hours will also be recorded. Uterine tone will be assessed by numerical rating score(0-100) at 3, 6, and 10 minutes after fetal delivery and the absolute 10 minute score as well as relative from 10-3 and 10-6 minute scores will also be analysed.Timepoint: 0 to 24 hours

Countries

India

Contacts

Public ContactRAKESH KUMAR

AIIMS NEW DELHI

drrakesh.kumar.akb@gmail.com

Outcome results

None listed

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