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

Phase 1

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

Registration Number: CTRI/2023/07/055182

Lead Sponsor: AIIMS New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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 <37 weeks, prior history of postpartum hemorrhage, labor induction or augmentation with oxytocin, advanced maternal age, obesity with body mass index >40.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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