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

Официальное название

Administration of Calcium Gluconate for the Reduction of Blood Loss During Vaginal Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат Normal saline placebo
  110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor

Первичные конечные точки

• Proportion of Participants With a Hemoglobin Decrease of ≥2 g/dL [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (6)

• Clinically Diagnosed Postpartum Hemorrhage [Срок оценки: From delivery until hospital discharge, assessed up to 4 days postpartum]
• Need for Additional Treatment for Postpartum Hemorrhage [Срок оценки: From delivery through 24 hours postpartum]
• Receipt of Blood Products [Срок оценки: Proportion of participants receiving blood products during the first 3 days postpartum.]
• Intravenous Iron Administration [Срок оценки: From delivery through postpartum Day 3.]
• Length of Hospital Stay [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Израиль · 1 центр

• Rambam Medical Center — Haifa

Идентификаторы

NCT: NCT07714902 · 0495-25-RMB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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