Effect of prophylactic intravenous calcium gluconate administration on blood loss in women undergoing cesarean section with risk factor for postpartum hemorrhage - a randomized controlled trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- To compare the effect of intravenous calcium gluconate with placebo on reduction of intrapartum blood loss in pregnant women posted for cesarean section with risk factor of postpartum hemorrhage.
Study Overview
Brief Summary
This study is a randomized, double blinded, placebo controlled trial accessing the effectiveness of calcium gluconate in reducing blood loss in during cesarean section. The main purpose of this study is to whether giving intravenous calcium gluconate will reduce postpartum bleeding in high-risk pregnancy like, twins, previous cesarean section, obese patients, etc. As calcium gluconate is readily available, cheap and economic, using it for the management of postpartum bleeding will be very effective. Similar studies have been done in normal healthy pregnant women and found to show positive results. So, we have extended it the next level, trying to evaluate its effect in high-risk pregnancy. The primary objective of this study is to estimate blood loss and secondary outcomes are to compare preoperative and postoperative ionized calcium levels and hemoglobin level by doing a venous blood gas analysis, accessing the uterine tone and monitoring changes in blood pressures and heart rate. The proposed hypothesis is that intravenous calcium gluconate is effective in reducing blood loss in women posted for cesarean section with risk factor for postpartum hemorrhage.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Age 18 years and more ASA 2 and 3 Gestational age more than 34 weeks Planned for c-section under spinal anesthesia Pregnant females with high risk for blood loss during c-section like previous cesarean section, twin pregnancy, severe obesity, history of previous postpartum hemorrhage.
Exclusion Criteria
- •Pregnant females with heart disease, chronic renal disease, placenta accreta sprectum, pregnant females who are taking calcium channel blockers like nifedipine tablets.
Outcomes
Primary Outcomes
To compare the effect of intravenous calcium gluconate with placebo on reduction of intrapartum blood loss in pregnant women posted for cesarean section with risk factor of postpartum hemorrhage.
Time Frame: At the end of the surgery
Secondary Outcomes
- 1.verbal numerical rating scale of uterine tone(2.baseline & postoperative hemoglobin)