NCT07550413

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for phase_2

Timeline
7mo left

Started May 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

April 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 19, 2026

Last Update Submit

April 19, 2026

Conditions

Keywords

Randomized Controlled Trial

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

EXPERIMENTAL

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).

Drug: Calcium Chloride

Group B

PLACEBO COMPARATOR

Group B will receive standard care with oxytocin alone.

Other: Placebo

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).

Group A
PlaceboOTHER

Group B will receive standard care with oxytocin alone.

Group B

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Calcium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsChloridesHydrochloric AcidChlorine Compounds

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

Locations