About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Gestational age of 37 weeks or more, and planning a vaginal delivery.
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
calcium gluconate
Drug10 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.
Normal saline placebo
Drug110 mL of 0.9% normal saline administered intravenously immediately following umbilical cord clamping during the third stage of labor
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Clinically Diagnosed Postpartum Hemorrhage
Proportion of participants with clinically diagnosed postpartum hemorrhage following vaginal delivery
Need for Additional Treatment for Postpartum Hemorrhage
Proportion of participants requiring additional medical or procedural treatment for management of PPH
Receipt of Blood Products
Proportion of participants receiving blood products during postpartum hospitalization
Intravenous Iron Administration
Proportion of participants treated with intravenous iron during postpartum hospitalization
Sponsors and contacts
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