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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRambam Health Care Campus

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • 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.

  • Normal saline placebo

    Drug

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

Treatment groups

710 Participants
are divided into 2 treatment groups
Group A: Calcium GluconateExperimental treatment 1 intervention
Group B: Placebo (Normal Saline)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.
2

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.

Time frame
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

1

Clinically Diagnosed Postpartum Hemorrhage

Proportion of participants with clinically diagnosed postpartum hemorrhage following vaginal delivery

Time frame
From delivery until hospital discharge, assessed up to 4 days postpartum
2

Need for Additional Treatment for Postpartum Hemorrhage

Proportion of participants requiring additional medical or procedural treatment for management of PPH

Time frame
From delivery through 24 hours postpartum
3

Receipt of Blood Products

Proportion of participants receiving blood products during postpartum hospitalization

Time frame
Proportion of participants receiving blood products during the first 3 days postpartum.
4

Intravenous Iron Administration

Proportion of participants treated with intravenous iron during postpartum hospitalization

Time frame
From delivery through postpartum Day 3.

Other outcomes

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