Post Partum Haemorrhage, Cesarean Section Surgery
Conditions
Keywords
Randomized Controlled Trial
Brief summary
To determine the effectiveness of prophylactic intravenous calcium chloride administered after cord clamping in reducing postpartum blood loss during intrapartum cesarean section.
Detailed description
After approval from the hospital's ethical review committee, written informed consent will be obtained from all participants. Baseline characteristics such as age, parity, gestational age, height, and weight for body mass index will be documented. A total of 182 women will be randomly allocated into two equal groups (91 each) using the lottery method. 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). Group B will receive standard care with oxytocin alone.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. The labeling and confirmation will be carried out by a consultant obstetrician with more than five years of experience, in collaboration with the researcher, at the end of the procedure.All data will be recorded using a predefined proforma.
Interventions
DRUGCalcium Chloride
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).
OTHERPlacebo
Group B will receive standard care with oxytocin alone.
Sponsors
Pak Emirates Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | 24 hours | 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. |
Countries
Pakistan
Contacts
CONTACTSumera Maqbool, MBBS
Outcome results
None listed