Current partner codePEPTIDESDE
NCT07550413·Phase 2·INTERVENTIONAL

Role of Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Section

Status

Not yet recruiting

Phase

Phase 2

Enrollment

182

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

To determine the effectiveness of prophylactic intravenous calcium chloride administered after cord clamping in reducing postpartum blood loss during intrapartum cesarean section.

Full 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

Treatment arms and agents.

DRUG

Calcium 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).

OTHER

Placebo

Group B will receive standard care with oxytocin alone.

Timeline

From registration to results.

  1. First posted

    Apr 24, 2026

  2. Study start

    May 2026

  3. Primary completion

    Nov 2026

  4. Study completion

    Dec 2026

  5. Results posted

    Not reported

  6. Registry updated

    Apr 24, 2026

Outcomes

What the study measures.

Primary outcomes

Blood Loss

Time frame · 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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
FEMALE
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.

Study locations

1 registered sites.

Pakistan. Showing up to 24 locations stored in the fast local snapshot.

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Oxytocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.