Administration Of Calcium Gluconate for The Reduction of Blood Loss During Vaginal Delivery

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: calcium gluconate; Drug: Normal saline placebo

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 Type: Interventional
• Enrollment (Estimated): 710
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gili Buchnik Fater, MD; Phone Number: +972546738628; Email: gili.buchnik@gmail.com

Study Locations

• Israel
  • Haifa, Israel, 6815408
    • Recruiting
    • Rambam Medical Center
    • Contact: Gili Buchnik Fater, MD; Phone Number: +972546738628; Email: gili.buchnik@gmail.com
    • Principal Investigator: Gili Buchnik Fater, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Gestational age of 37 weeks or more, and planning a vaginal delivery.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calcium Gluconate; 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.	Drug: calcium gluconate; 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.
Placebo Comparator: Placebo (Normal Saline); Participants will receive 110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor.	Drug: Normal saline placebo; 110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Diagnosed Postpartum Hemorrhage	Proportion of participants with clinically diagnosed postpartum hemorrhage following vaginal delivery	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	From delivery through 24 hours postpartum
Receipt of Blood Products	Proportion of participants receiving blood products during postpartum hospitalization	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	From delivery through postpartum Day 3.
Length of Hospital Stay	Duration of postpartum hospitalization after vaginal delivery.	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.	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)

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Estimated): June 24, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Postpartum Hemorrhage; Vaginal Delivery; Uterine Atony; Third Stage of Labor; Postpartum Blood Loss; Calcium Gluconate
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Dystocia; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage; Uterine Inertia; Organic Chemicals; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Gluconates; Calcium Gluconate
• Other Study ID Numbers: 0495-25-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No