Postpartum HemorrhageNCT07714902
Administration Of Calcium Gluconate for The Reduction of Blood Loss During Vaginal Delivery
A study testing calcium gluconate in people with Postpartum Hemorrhage, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Postpartum hemorrhage is one of the leading causes of maternal morbidity following childbirth. Even when excessive bleeding is not clinically recognized, some women experience a significant decrease in hemoglobin levels after delivery, which may result in anemia, fatigue, delayed recovery, and the need for additional… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- calcium gluconate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 710 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Jun 2026to 1 Dec 2027
- Phase
- Interventional
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestational age of 37 weeks or more, and planning a vaginal delivery.
Who cannot join
- Age younger than 18 years old.
- Patients treated with calcium channel blockers
- Patients with Preeclampsia with severe features receiving magnesium sulfate infusion.
- Chronic renal failure and hyperphosphatemia
- Patients with known Para-Thyroid disease
- Sarcoidosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa, 6815408
Gili Buchnik Fater, MD, +972546738628, gili.buchnik@gmail.com
Gili Buchnik Fater, MD
About this study
Official title: Administration of Calcium Gluconate for the Reduction of Blood Loss During Vaginal Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial
Postpartum hemorrhage is one of the leading causes of maternal morbidity following childbirth. Even when excessive bleeding is not clinically recognized, some women experience a significant decrease in hemoglobin levels after delivery, which may result in anemia, fatigue, delayed recovery, and the need for additional medical treatment.
Calcium plays an important role in uterine muscle contraction and blood clotting. Previous studies have suggested that calcium administration may help reduce blood loss after childbirth. However, there is limited evidence regarding its effectiveness during vaginal delivery.
Read more
The purpose of this study is to evaluate whether administration of intravenous calcium gluconate immediately after umbilical cord clamping can reduce postpartum blood loss following vaginal delivery.
Participants will be randomly assigned to receive either calcium gluconate or a placebo solution immediately after umbilical cord clamping during vaginal delivery. Neither the participants nor their healthcare providers will know which treatment was administered. Blood tests routinely obtained during hospitalization after delivery will be used to assess changes in hemoglobin levels and other outcomes related to postpartum bleeding.
The results of this study may help determine whether calcium gluconate is a safe and effective intervention for reducing postpartum blood loss after vaginal delivery.
Read the detailed description
Postpartum hemorrhage (PPH) remains a major cause of maternal morbidity worldwide. In addition to clinically recognized PPH, a substantial proportion of women experience significant postpartum hemoglobin decline without overt signs of excessive bleeding. Such blood loss may contribute to postpartum anemia, fatigue, delayed recovery, and increased healthcare utilization.
Calcium plays a critical role in both uterine muscle contraction and the coagulation cascade. Transient reductions in serum calcium concentrations have been observed during labor and immediately after delivery. It has been hypothesized that calcium supplementation during the third stage of labor may enhance uterine contractility and reduce postpartum blood loss.
The objective of this randomized, double-blind, placebo-controlled trial is to evaluate whether intravenous calcium gluconate administered immediately after umbilical cord clamping reduces postpartum blood loss following vaginal delivery.
Eligible participants will be randomized in a 1:1 ratio to receive either 10 mL of 10% calcium gluconate diluted in 100 mL of normal saline or 110 mL of normal saline placebo administered intravenously immediately after umbilical cord clamping. Participants, healthcare providers, and outcome assessors will remain blinded to treatment allocation.
The co-primary outcomes are: (1) the proportion of participants experiencing a hemoglobin decrease of at least 2 g/dL from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization, and (2) the mean change in hemoglobin level from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization.
Secondary outcomes include clinically diagnosed postpartum hemorrhage, need for additional uterotonic medications, blood transfusion, intravenous iron administration, length of hospital stay, and composite maternal morbidity outcomes.
The findings of this study may provide evidence regarding the effectiveness and safety of calcium gluconate as a simple and inexpensive intervention for reducing postpartum blood loss after vaginal delivery.
- Conditions
- Postpartum Hemorrhage
- Being tested
- calcium gluconate, Normal saline placebo
- Keywords
- Postpartum Hemorrhage, Postpartum Blood Loss, Calcium Gluconate, Vaginal Delivery, Uterine Atony, Third Stage of Labor
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium gluconateDrug
10 mL of 10% calcium gluconate solution (0.94 g calcium gluconate) diluted in 100 mL of normal saline and administered intravenously immediately following umbilical cord clamping during the third stage of labor.
Normal saline placeboDrug
110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor
| Study group | Role | What they receive |
|---|---|---|
| Calcium Gluconate | Experimental | Participants will receive 10 mL of 10% calcium gluconate solution (0.94 g calcium gluconate) diluted in 100 mL normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor. Receives: Drug: calcium gluconate |
| Placebo (Normal Saline) | Placebo comparator | Participants will receive 110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor. Receives: Drug: Normal saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With a Hemoglobin Decrease of ≥2 g/dL
Proportion of participants with a decrease of at least 2 g/dL in hemoglobin concentration from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization. Hemoglobin levels will be routinely measured 24-48 hours after vaginal delivery; if additional hemoglobin measurements are obtained later during hospitalization, the lowest recorded value will be used for analysis.
Measured: From pre-delivery baseline to 24-48 hours postpartum. If additional Hb measurements are obtained later during hospitalization and demonstrate a further decline, the lowest hemoglobin value recorded during the hospitalization will be used for analysis.
Mean Change in Hemoglobin Level
Proportion of participants with a decrease of at least 2 g/dL in hemoglobin concentration from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization. Hemoglobin levels will be routinely measured 24-48 hours after vaginal delivery; if additional hemoglobin measurements are obtained later during hospitalization, the lowest recorded value will be used for analysis.
Measured: From pre-delivery baseline to 24-48 hours postpartum. If additional Hb measurements are obtained later during hospitalization and demonstrate a further decline, the lowest hemoglobin value recorded during the hospitalization will be used for analysis.
Secondary outcomes (6)
Clinically Diagnosed Postpartum Hemorrhage
Proportion of participants with clinically diagnosed postpartum hemorrhage following vaginal delivery
Measured: From delivery until hospital discharge, assessed up to 4 days postpartum
Need for Additional Treatment for Postpartum Hemorrhage
Proportion of participants requiring additional medical or procedural treatment for management of PPH
Measured: From delivery through 24 hours postpartum
Receipt of Blood Products
Proportion of participants receiving blood products during postpartum hospitalization
Measured: Proportion of participants receiving blood products during the first 3 days postpartum.
Intravenous Iron Administration
Proportion of participants treated with intravenous iron during postpartum hospitalization
Measured: From delivery through postpartum Day 3.
Length of Hospital Stay
Duration of postpartum hospitalization after vaginal delivery.
Measured: From delivery to hospital discharge. Most participants are discharged within 36-48 hours postpartum; however, follow-up continues until hospital discharge for participants with prolonged hospitalization due to maternal complications.
Composite Adverse Maternal Outcome
Proportion of participants experiencing at least one of the following adverse maternal outcomes: intensive care unit admission, surgical treatment for uncontrolled postpartum hemorrhage, massive blood transfusion, disseminated intravascular coagulation, or maternal death.
Measured: From delivery to hospital discharge. Most participants are discharged within 36-48 hours; participants with prolonged hospitalization will be followed until discharge (up to 30 days postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start24 Jun 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714902
- Sponsor's protocol ID
- 0495-25-RMB
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet determined whether de-identified individual participant data will be shared. Any future data sharing will be considered in accordance with institutional policies, ethical approvals, and participant privacy protections.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Calcium Gluconate for the Reduction of Blood Loss During Vaginal Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07714902
- Acronym / sponsor ID
- 0495-25-RMB
- Conditions
- Postpartum Hemorrhage
- Keywords
- Postpartum Hemorrhage, Postpartum Blood Loss, Calcium Gluconate, Vaginal Delivery, Uterine Atony, Third Stage of Labor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 24 Jun 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Jul 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.
Postpartum hemorrhage is one of the leading causes of maternal morbidity following childbirth. Even when excessive bleeding is not clinically recognized, some women experience a significant decrease in hemoglobin levels after delivery, which may result in anemia, fatigue, delayed recovery, and the need for additional medical treatment.
Calcium plays an important role in uterine muscle contraction and blood clotting. Previous studies have suggested that calcium administration may help reduce blood loss after childbirth. However, there is limited evidence regarding its effectiveness during vaginal delivery.
The purpose of this study is to evaluate whether administration of intravenous calcium gluconate immediately after umbilical cord clamping can reduce postpartum blood loss following vaginal delivery.
Participants will be randomly assigned to receive either calcium gluconate or a placebo solution immediately after umbilical cord clamping during vaginal delivery. Neither the participants nor their healthcare providers will know which treatment was administered. Blood tests routinely obtained during hospitalization after delivery will be used to assess changes in hemoglobin levels and other outcomes related to postpartum bleeding.
The results of this study may help determine whether calcium gluconate is a safe and effective intervention for reducing postpartum blood loss after vaginal delivery.
Detailed description
Postpartum hemorrhage (PPH) remains a major cause of maternal morbidity worldwide. In addition to clinically recognized PPH, a substantial proportion of women experience significant postpartum hemoglobin decline without overt signs of excessive bleeding. Such blood loss may contribute to postpartum anemia, fatigue, delayed recovery, and increased healthcare utilization.
Calcium plays a critical role in both uterine muscle contraction and the coagulation cascade. Transient reductions in serum calcium concentrations have been observed during labor and immediately after delivery. It has been hypothesized that calcium supplementation during the third stage of labor may enhance uterine contractility and reduce postpartum blood loss.
The objective of this randomized, double-blind, placebo-controlled trial is to evaluate whether intravenous calcium gluconate administered immediately after umbilical cord clamping reduces postpartum blood loss following vaginal delivery.
Eligible participants will be randomized in a 1:1 ratio to receive either 10 mL of 10% calcium gluconate diluted in 100 mL of normal saline or 110 mL of normal saline placebo administered intravenously immediately after umbilical cord clamping. Participants, healthcare providers, and outcome assessors will remain blinded to treatment allocation.
The co-primary outcomes are: (1) the proportion of participants experiencing a hemoglobin decrease of at least 2 g/dL from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization, and (2) the mean change in hemoglobin level from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization.
Secondary outcomes include clinically diagnosed postpartum hemorrhage, need for additional uterotonic medications, blood transfusion, intravenous iron administration, length of hospital stay, and composite maternal morbidity outcomes.
The findings of this study may provide evidence regarding the effectiveness and safety of calcium gluconate as a simple and inexpensive intervention for reducing postpartum blood loss after vaginal delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Gluconate | Experimental | Drug: calcium gluconateParticipants will receive 10 mL of 10% calcium gluconate solution (0.94 g calcium gluconate) diluted in 100 mL normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor. |
| Placebo (Normal Saline) | Placebo comparator | Drug: Normal saline placeboParticipants will receive 110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gestational age of 37 weeks or more, and planning a vaginal delivery.
Key exclusion criteria (6 listed)
- Age younger than 18 years old.
- Patients treated with calcium channel blockers
- Patients with Preeclampsia with severe features receiving magnesium sulfate infusion.
- Chronic renal failure and hyperphosphatemia
- Patients with known Para-Thyroid disease
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 gluconate10 mL of 10% calcium gluconate solution (0.94 g calcium gluconate) diluted in 100 mL of normal saline and administered intravenously immediately following umbilical cord clamping during the third stage of labor. | Drug | Calcium Gluconate |
| Normal saline placebo110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor | Drug | Placebo (Normal Saline) |
Primary outcome
Proportion of Participants With a Hemoglobin Decrease of ≥2 g/dL
Time frame: From pre-delivery baseline to 24-48 hours postpartum. If additional Hb measurements are obtained later during hospitalization and demonstrate a further decline, the lowest hemoglobin value recorded during the hospitalization will be used for analysis.
Proportion of participants with a decrease of at least 2 g/dL in hemoglobin concentration from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization. Hemoglobin levels will be routinely measured 24-48 hours after vaginal delivery; if additional hemoglobin measurements are obtained later during hospitalization, the lowest recorded value will be used for analysis.
Mean Change in Hemoglobin Level
Time frame: From pre-delivery baseline to 24-48 hours postpartum. If additional Hb measurements are obtained later during hospitalization and demonstrate a further decline, the lowest hemoglobin value recorded during the hospitalization will be used for analysis.
Proportion of participants with a decrease of at least 2 g/dL in hemoglobin concentration from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization. Hemoglobin levels will be routinely measured 24-48 hours after vaginal delivery; if additional hemoglobin measurements are obtained later during hospitalization, the lowest recorded value will be used for analysis.
6 secondary outcomes
Clinically Diagnosed Postpartum Hemorrhage
Time frame: From delivery until hospital discharge, assessed up to 4 days postpartum
Need for Additional Treatment for Postpartum Hemorrhage
Time frame: From delivery through 24 hours postpartum
Receipt of Blood Products
Time frame: Proportion of participants receiving blood products during the first 3 days postpartum.
Intravenous Iron Administration
Time frame: From delivery through postpartum Day 3.
Length of Hospital Stay
Time frame: From delivery to hospital discharge. Most participants are discharged within 36-48 hours postpartum; however, follow-up continues until hospital discharge for participants with prolonged hospitalization due to maternal complications.
Composite Adverse Maternal Outcome
Time frame: From delivery to hospital discharge. Most participants are discharged within 36-48 hours; participants with prolonged hospitalization will be followed until discharge (up to 30 days postpartum)
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 20 Jul 2026.
- Individual participant dataSharing planned: Undecided. The investigators have not yet determined whether de-identified individual participant data will be shared. Any future data sharing will be considered in accordance with institutional policies, ethical approvals, and participant privacy protections.
Related trials for Postpartum Hemorrhage
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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 study testing calcium gluconate in people with Postpartum Hemorrhage, run by Rambam Health Care Campus at 1 site in Israel.
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 1 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: looking for participants now, as of the sponsor's last update on 20 Jul 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 Israel. 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.
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 Gili Buchnik Fater, MD (+972546738628, gili.buchnik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With a Hemoglobin Decrease of ≥2 g/dL (time frame: From pre-delivery baseline to 24-48 hours postpartum. If additional Hb measurements are obtained later during hospitalization and demonstrate a further decline, the lowest hemoglobin value recorded during the hospitalization will be used for analysis.). The study lists 2 primary outcomes in all. 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 20 Jul 2026.