Post Partum HaemorrhagePhase 2NCT07550413
Role of Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Section
A Phase 2 study testing Calcium Chloride in people with Post Partum Haemorrhage and Cesarean Section Surgery, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial summary
To determine the effectiveness of prophylactic intravenous calcium chloride administered after cord clamping in reducing postpartum blood loss during intrapartum cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Haemorrhage, Cesarean Section Surgery
- What is being tested?
- Calcium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 sitePakistan
- Study dates
- May 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, 44000
About this study
To determine the effectiveness of prophylactic intravenous calcium chloride administered after cord clamping in reducing postpartum blood loss during intrapartum cesarean section.
Read the 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.
- Conditions
- Post Partum Haemorrhage, Cesarean Section Surgery
- Being tested
- Calcium Chloride, Placebo
- Keywords
- Randomized Controlled Trial
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium ChlorideDrug
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).
PlaceboOther
Group B will receive standard care with oxytocin alone.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Calcium Chloride |
| Group B | Placebo comparator | Group B will receive standard care with oxytocin alone. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Nisar, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550413
- Sponsor's protocol ID
- 20042026
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Section
- ClinicalTrials.gov ID
- NCT07550413
- Acronym / sponsor ID
- 20042026
- Conditions
- Post Partum Haemorrhage, Cesarean Section Surgery
- Keywords
- Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Calcium ChlorideGroup 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 comparator | Other: PlaceboGroup B will receive standard care with oxytocin alone. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium ChlorideGroup 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 | Group A |
| PlaceboGroup B will receive standard care with oxytocin alone. | Other | Group B |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium Chloride in people with Post Partum Haemorrhage and Cesarean Section Surgery, run by Pak Emirates Military Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sumera Maqbool, MBBS (+92 344 5346622 ext. +92, Sumeramaqbool777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Loss (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.