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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Gili Buchnik Fater, MD
- 電話番号：+972546738628
- メール：gili.buchnik@gmail.com
研究場所
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Haifa、イスラエル、6815408
- 募集
- Rambam Medical Center
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コンタクト：
- Gili Buchnik Fater, MD
- 電話番号：+972546738628
- メール：gili.buchnik@gmail.com
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主任研究者：
- Gili Buchnik Fater, MD
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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プラセボコンパレーター：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.
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110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants With a Hemoglobin Decrease of ≥2 g/dL
時間枠：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.
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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.
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Mean Change in Hemoglobin Level
時間枠：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.
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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.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinically Diagnosed Postpartum Hemorrhage
時間枠：From delivery until hospital discharge, assessed up to 4 days postpartum
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Proportion of participants with clinically diagnosed postpartum hemorrhage following vaginal delivery
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From delivery until hospital discharge, assessed up to 4 days postpartum
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Need for Additional Treatment for Postpartum Hemorrhage
時間枠：From delivery through 24 hours postpartum
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Proportion of participants requiring additional medical or procedural treatment for management of PPH
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From delivery through 24 hours postpartum
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Receipt of Blood Products
時間枠：Proportion of participants receiving blood products during the first 3 days postpartum.
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Proportion of participants receiving blood products during postpartum hospitalization
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Proportion of participants receiving blood products during the first 3 days postpartum.
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Intravenous Iron Administration
時間枠：From delivery through postpartum Day 3.
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Proportion of participants treated with intravenous iron during postpartum hospitalization
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From delivery through postpartum Day 3.
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Length of Hospital Stay
時間枠：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.
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Duration of postpartum hospitalization after vaginal delivery.
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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.
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Composite Adverse Maternal Outcome
時間枠：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)
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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.
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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)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 0495-25-RMB
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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