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

NCT07714902 | Recruiting

• 1 other identifier: 0495-25-RMB
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Postpartum Hemorrhage

Keywords

Postpartum Hemorrhage; Postpartum Blood Loss; Calcium Gluconate; Vaginal Delivery; Uterine Atony; Third Stage of Labor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Clinically Diagnosed Postpartum Hemorrhage

  From delivery until hospital discharge, assessed up to 4 days postpartum

• Need for Additional Treatment for Postpartum Hemorrhage

  From delivery through 24 hours postpartum

• Receipt of Blood Products

  Proportion of participants receiving blood products during the first 3 days postpartum.

• Intravenous Iron Administration

  From delivery through postpartum Day 3.

• Length of Hospital Stay

  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.

Study Arms (2)

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.

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.

Drug: Normal saline placebo

Interventions

calcium gluconate DRUG

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.

Calcium Gluconate

Normal saline placebo DRUG

110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor

Placebo (Normal Saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, 6815408, Israel

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia

Interventions

Calcium Gluconate

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dystocia

Intervention Hierarchy (Ancestors)

Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Gili Buchnik Fater, MD

CONTACT

+972546738628; gili.buchnik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: July 20, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

IL (1)