Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05027048
Other study ID # 62206
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 4, 2022
Est. completion date April 3, 2023

Study information

Verified date August 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. Up to 80% of PPH is caused by uterine atony, the failure of the uterine smooth muscle to contract and compress the uterine vasculature after delivery. Laboratory and epidemiological studies show that low extracellular and serum calcium levels, respectively, decrease uterine contractility. A pilot study performed by the investigators supports the hypothesis that intravenous calcium chloride is well tolerated and may have utility in preventing uterine atony. The proposed research will establish the relationship between uterine tone and calcium through a clinical trial with an incorporated pharmacokinetic and pharmacodynamic (PK/PD) study. In a randomized, placebo-controlled, double-blind trial, investigators will establish the effect of 1 gram of intravenous calcium chloride upon quantitative blood loss and uterine tone during cesarean delivery in parturients with high risk of uterine atony. Investigators will concurrently collect serial venous blood samples to measure calcium for PK/PD modeling in this pregnant study cohort. High-quality clinical research and development of novel therapeutics to manage uterine atony are critical to reduce the high maternal morbidity and mortality from PPH.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date April 3, 2023
Est. primary completion date March 29, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Patient had a trial of labor for vaginal delivery prior to cesarean - Patient received an oxytocin infusion for labor augmentation or induction prior to cesarean Exclusion Criteria: - renal dysfunction with serum Cr >1.0 mg/dL - known underlying cardiac condition - treatment with digoxin within the last 2 weeks for a maternal or fetal indication - treatment with a calcium channel blocker medication within 24 hours - hypertension necessitating intravenous antihypertensive medication within 24 hours - emergent case in which study participation could in any way impede patient care by the judgement of the obstetrician, anesthesiologist, or bedside nurse

Study Design


Intervention

Drug:
Calcium chloride
See arm description above
Saline placebo
see arm description above

Locations

Country Name City State
United States Jessica Ansari Pacifica California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative Blood Loss Standardized volumetric and gravimetric assessment of blood loss during cesarean. Note: will analyze all participants, but planned subgroup analysis will also occur excluding patients with non-atonic reasons for blood loss including hysterotomy extension, placental abruption, cervical or vaginal laceration, etc measurement occurs at conclusion of operating room case
Secondary Uterine tone numerical rating score Uterine tone assessment 2, 7, and 12 minutes after fetal delivery. The absolute 12 minute score as well as delta from 12-2 and 12-7 minute scores will be analyzed
Secondary Second line uterotonic requirement Yes/no: did the patient require treatment with methylergonovine, carboprost, and/or misoprostol for uterine atony within 4 hours of delivery
Secondary Fluid requirement Total crystalloid required during cesarean delivery in mL Operating room duration, usually 2 hours
Secondary Total oxytocin bolus requirement Total dose oxytocin bolus during cesarean Cesarean duration, usually about 2 hours
Secondary Transfusion requirement Yes/no and total units packed red blood cells 96 hours of delivery
Secondary Pharmacokinetics of calcium chloride analyzed in NONMEM using serial venous blood gas ionized calcium levels from willing participants Within 4 hours of study drug administration
Secondary Pharmacodynamic effect of calcium upon uterine tone NRS also analyzed in NONMEM Within 20 minutes of study drug administration
Secondary Percent change in heart rate from baseline Baseline heart rate recorded as average of first 6 heart rates recorded in operating room. Percent change calculated as measured heart rate minus baseline, divided by baseline. every 5 minutes for 30 minutes after study drug infusion initiation, compared to baseline
Secondary Percent change in mean arterial blood pressure from baseline Baseline mean arterial blood pressure recorded as average of first 6 mean arterial blood pressures recorded in operating room. Percent change calculated as measured mean arterial blood pressure minus baseline, divided by baseline. every 5 minutes for 30 minutes after study drug infusion initiation, compared to baseline
Secondary Total phenylephrine requirement Total phenylephrine in milligrams administered while in the operating room Duration of operating room time
Secondary Change in hematocrit from baseline Measured pre-delivery hematocrit minus measured post-operative day 1 hematocrit. Correction factor of 3 hematocrit points per unit packed red blood cells transfused 1 day
See also
  Status Clinical Trial Phase
Terminated NCT04377984 - Impact of a Strategy Combining Morphine Savings and Anesthesia Technique on the Quality of Post-operative Rehabilitation
Recruiting NCT03248817 - Phenylephrine Infusion in Cesarean Delivery Phase 4
Completed NCT05037383 - Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions N/A
Not yet recruiting NCT05933993 - Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
Recruiting NCT05021315 - Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection Phase 3
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Recruiting NCT06010368 - Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section Phase 3
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Not yet recruiting NCT06017076 - Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery. N/A
Completed NCT05005871 - Comparison of Quadratus Lumborum Intramuscular and Transmuscular in Postoperative Pain N/A
Recruiting NCT04518176 - Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins N/A
Not yet recruiting NCT04505644 - Lidocaine Patch Versus Intravenous Lidocaine in Pain Relief After Cesarean Section N/A
Not yet recruiting NCT03985618 - The MODE Trial: Planned Caesarean Section Versus Induction of Labour for Women With Class III Obesity N/A
Completed NCT04046510 - Comparaison of 3 Protocols of Ocytocin Administration in C Section N/A
Completed NCT03302039 - Three Protocols for Phenylephrine Administration in Cesarean Delivery Phase 4
Completed NCT03318536 - Effect of Granisetron on Usage of Sympathomimetics During Caesarean Section
Recruiting NCT03682510 - B-Lynch Transverse Compression Suture Versus a Sandwich Technique (N&H Technique) for Complete Placenta Previa N/A
Recruiting NCT03651076 - Traxi Panniculus Retractor for Cesarean Delivery N/A
Not yet recruiting NCT06060327 - Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section N/A
Completed NCT03701048 - Rectus Musle Reapproximation During Cesarean Section N/A