Role of Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Section
1 other identifier
interventional
182
1 country
1
Brief Summary
To determine the effectiveness of prophylactic intravenous calcium chloride administered after cord clamping in reducing postpartum blood loss during intrapartum cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2026
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2026
CompletedFirst Posted
Study publicly available on registry
April 24, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 24, 2026
April 1, 2026
6 months
April 19, 2026
April 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Loss
Quantitative blood loss will be calculated using the gravimetric method. All surgical swabs, drapes, and pads will be weighed immediately after use, and their pre-determined dry weights will be subtracted to obtain the net blood loss, with the assumption that 1 g of weight gain is equivalent to 1 mL of blood. Blood collected in suction containers will also be measured. Adjustment for amniotic fluid will be made by recording the volume of clear amniotic fluid suctioned immediately after uterine incision and before placental delivery, which will then be subtracted from the total suction volume. Each weighed item and suction measurement will be labeled sequentially according to the patient's study ID at the time of surgery.
24 hours
Study Arms (2)
Group A
EXPERIMENTALGroup A will receive 1 g of intravenous calcium chloride diluted in 100 mL of normal saline, administered over 10 minutes beginning one minute after cord clamping, in addition to standard oxytocin therapy (10 IU intravenous bolus followed by 20 IU infusion).
Group B
PLACEBO COMPARATORGroup B will receive standard care with oxytocin alone.
Interventions
Group A will receive 1 g of intravenous calcium chloride diluted in 100 mL of normal saline, administered over 10 minutes beginning one minute after cord clamping, in addition to standard oxytocin therapy (10 IU intravenous bolus followed by 20 IU infusion).
Eligibility Criteria
You may qualify if:
- Women aged 18-45 years undergoing intrapartum cesarean section at ≥34 weeks of gestation.
- Exposure to oxytocin during labor before CS.
- Singleton pregnancy with no known fetal anomalies.
You may not qualify if:
- Known bleeding disorders or preoperative coagulation abnormalities
- Preeclampsia or hypertensive disorders contraindicate calcium use.
- History of cardiac disease or arrhythmias
- Placental abnormalities, i.e., placenta previa, accreta
- Emergency CS with fetal distress or cord prolapse.
- Known hypersensitivity to calcium chloride.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, 44000, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Registrar
Study Record Dates
First Submitted
April 19, 2026
First Posted
April 24, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04