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

14. Juli 2026 aktualisiert von: Rambam Health Care Campus

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

710

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Israel
      • Haifa, Israel, 6815408
        • Rekrutierung
        • Rambam Medical Center
        • Kontakt:
        • Hauptermittler:
          • Gili Buchnik Fater, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Arzneimittel: 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-Komparator: 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.
Arzneimittel: Normal saline placebo
110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of Participants With a Hemoglobin Decrease of ≥2 g/dL
Zeitfenster: 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.
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
Zeitfenster: 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.
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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinically Diagnosed Postpartum Hemorrhage
Zeitfenster: From delivery until hospital discharge, assessed up to 4 days postpartum
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
Zeitfenster: From delivery through 24 hours postpartum
Proportion of participants requiring additional medical or procedural treatment for management of PPH
From delivery through 24 hours postpartum
Receipt of Blood Products
Zeitfenster: Proportion of participants receiving blood products during the first 3 days postpartum.
Proportion of participants receiving blood products during postpartum hospitalization
Proportion of participants receiving blood products during the first 3 days postpartum.
Intravenous Iron Administration
Zeitfenster: From delivery through postpartum Day 3.
Proportion of participants treated with intravenous iron during postpartum hospitalization
From delivery through postpartum Day 3.
Length of Hospital Stay
Zeitfenster: 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.
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
Zeitfenster: 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)
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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Rambam Health Care Campus

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

24. Juni 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

3. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juli 2026

Zuerst gepostet (Tatsächlich)

20. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 0495-25-RMB

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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