Trial Outcomes & Findings for Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery (NCT NCT05027048)
NCT ID: NCT05027048
Last Updated: 2024-06-11
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
measurement occurs at conclusion of operating room case
Results posted on
2024-06-11
Participant Flow
Participant milestones
| Measure |
Calcium Chloride
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latina
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic white
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or declines to state
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Body Mass index (kg/m^2)
|
31.6 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
32.2 kg/m^2
STANDARD_DEVIATION 6.1 • n=7 Participants
|
31.9 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Gravida (n)
|
1 pregnancies
n=5 Participants
|
1 pregnancies
n=7 Participants
|
1 pregnancies
n=5 Participants
|
|
Para
|
0 Prior pregnancies
n=5 Participants
|
0 Prior pregnancies
n=7 Participants
|
0 Prior pregnancies
n=5 Participants
|
|
Gestational age (completed weeks)
|
39 completed weeks
n=5 Participants
|
39 completed weeks
n=7 Participants
|
39 completed weeks
n=5 Participants
|
|
Advanced maternal age (n, %)
|
28 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Hypertension from all causes (n, %)
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Preeclampsia (n, %)
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Diabetes, all causes (n, %)
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Asthma (n, %)
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Multiple gestation (n, %)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Chorioamnionitis (n, %)
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Trial of Labor after Cesarean (TOLAC) (n, %)
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Indication: first stage arrest
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Indication: second stage arrest
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Indication: fetal intolerance of labor
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Indication: failed operative vaginal delivery
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Indication: maternal request
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Indication: other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Maximum oxytocin dose in labor
|
11.7 milliunits per minute
STANDARD_DEVIATION 8.5 • n=5 Participants
|
12.4 milliunits per minute
STANDARD_DEVIATION 9.1 • n=7 Participants
|
12.1 milliunits per minute
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Hours of oxytocin exposure during labor
|
16.3 hours
STANDARD_DEVIATION 12.0 • n=5 Participants
|
18.5 hours
STANDARD_DEVIATION 12.1 • n=7 Participants
|
17.4 hours
STANDARD_DEVIATION 12.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: measurement occurs at conclusion of operating room caseStandardized 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
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Quantitative Blood Loss
|
840 milliliters
Interval 650.0 to 1434.0
|
1051 milliliters
Interval 796.0 to 1395.0
|
SECONDARY outcome
Timeframe: operative course (within 4-6 hours of fetal delivery)Postpartum hemorrhage was defined as quantitative blood loss \> 1000 milliliters during operative course
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Number of Participants With Postpartum Hemorrhage
|
24 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: within 4 hours of deliveryYes/no: did the patient require treatment with methylergonovine, carboprost, and/or misoprostol for uterine atony
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Number of Participants With Second Line Uterotonic Requirement
|
18 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 96 hours of deliveryYes/no, if patient required transfusion of packed red blood cells prior to hospital discharge
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Number of Patients With a Transfusion Requirement
|
5 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 dayMeasured pre-delivery hematocrit minus measured post-operative day 1 hematocrit. Correction factor of 3 hematocrit points per unit packed red blood cells transfused
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Change in Hematocrit From Baseline
|
7.8 Percentage of hematocrit
Interval 6.6 to 9.2
|
9.6 Percentage of hematocrit
Interval 8.1 to 11.7
|
SECONDARY outcome
Timeframe: Cesarean duration, within 4-6 hours of fetal deliveryPopulation: Note: institutional standard policy is a 2 unit oxytocin bolus at the time of fetal delivery, with additional boluses prn
Total dose oxytocin bolus during cesarean
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Total Oxytocin Bolus Requirement
|
3 units
Interval 2.0 to 4.0
|
3 units
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 7 minutes after fetal delivery, 5 minutes after initiating study drug infusionUterine tone assessment: Obstetricians at the study institution use the following validated scale to grade uterine tone for all cesarean deliveries. The obstetrician places their hand directly on the uterine fundus and scores the adequacy of contraction. The interrater characteristics of this scale have been published (Cole et al, 2021). The scale ranges from 0-10. A score of 0 is the worst possible score and represents a flaccid, atonic uterus. A score of 10 is the best possible score and represents a firmly-contracted uterus.
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Uterine Tone Numerical Rating Score, 7 Minutes After Fetal Delivery
|
7 units on a scale
Interval 6.0 to 8.0
|
6.5 units on a scale
Interval 6.0 to 7.0
|
SECONDARY outcome
Timeframe: 12 minutes after fetal delivery, 10 minutes after initiating study drug infusionUterine tone assessment: Obstetricians at the study institution use the following validated scale to grade uterine tone for all cesarean deliveries. The obstetrician places their hand directly on the uterine fundus and scores the adequacy of contraction. The interrater characteristics of this scale have been published (Cole et al, PMID 33652161). The scale ranges from 0-10. A score of 0 is the worst possible score and represents a flaccid, atonic uterus. A score of 10 is the best possible score and represents a firmly-contracted uterus.
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Uterine Tone Numerical Rating Score, 12 Minutes After Fetal Delivery
|
7 units on a scale
Interval 6.0 to 8.0
|
7 units on a scale
Interval 6.0 to 8.0
|
SECONDARY outcome
Timeframe: Operating room duration, usually 2 hoursTotal crystalloid required during cesarean delivery in mL
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Fluid Requirement
|
1594 milliliters
Standard Deviation 762
|
1502 milliliters
Standard Deviation 892
|
SECONDARY outcome
Timeframe: every 5 minutes for 30 minutes after study drug infusion initiation, compared to baselineBaseline 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. Reported here as the maximal decrease in mean arterial pressure. Repeated measures ANOVA reported in Statistical Analysis.
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Percent Change in Mean Arterial Pressure
|
16 percent change
Interval 11.0 to 21.0
|
12 percent change
Interval 4.0 to 20.0
|
SECONDARY outcome
Timeframe: every 5 minutes for 30 minutes after study drug infusion initiation, compared to baselineBaseline 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. Maximal % increase in heart rate reported here. Repeated measures ANOVA used to analyze overall trend in Statistical Analysis below.
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Percent Change in Heart Rate From Baseline
|
0 percent change
Interval -4.0 to 5.0
|
10 percent change
Interval 4.0 to 15.0
|
SECONDARY outcome
Timeframe: Duration of operating room time, up to 240 minutesPopulation: Total of documented phenylephrine bolus and infusion administration during operative course
Total phenylephrine in milligrams administered while in the operating room
Outcome measures
| Measure |
Calcium Chloride
n=60 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Total Phenylephrine Requirement
|
1.02 milligrams
Interval 0.0 to 2.26
|
1.09 milligrams
Interval 0.08 to 2.72
|
SECONDARY outcome
Timeframe: In the operating room prior to study drug administration (generally <30 minutes prior to fetal delivery and study drug administration)Population: A total of 35 trial participants consented to provide serial blood specimens for ionized calcium measurement and pharmacokinetic analysis, per protocol.
Measured using an Abbott istat machine and CG8+ cartridge to determine venous blood gas ionized calcium levels
Outcome measures
| Measure |
Calcium Chloride
n=19 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=16 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Pharmacokinetics of Calcium Chloride - Baseline Ionized Calcium
|
1.15 mmoL / liter
Standard Deviation 0.02
|
1.16 mmoL / liter
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: At Tmax (conclusion of the 10-minute intravenous calcium chloride infusionPopulation: Participants who participated in the nested pharmacokinetic study and were randomly assigned to the calcium chloride group.
Generated from a 2-compartment population pharmacokinetic model in NONMEM using serial venous blood gas ionized calcium concentrations.
Outcome measures
| Measure |
Calcium Chloride
n=18 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Pharmacokinetics of Calcium Chloride - Peak Change in Ionized Calcium From 1 Gram of Calcium Chloride
|
0.39 mmoL / liter
Interval 0.37 to 0.42
|
—
|
SECONDARY outcome
Timeframe: Within 20 minutes of study drug administrationPopulation: Data not collected (unable to obtain blood specimens at the time of tone scores)
Data were not collected. This measure required blood specimens to be obtained at the time of tone scores and this was not done.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Calculated at conclusion of operating room casePopulation: Pre=specified subgroup analysis, excluded cases of documented nonatonic bleeding (mostly due to hysterotomy extension, present in 21 participants allocated to calcium and 20 participants allocated to placebo).
Pre-specified subgroup analysis of primary outcome: Because the proposed mechanism of calcium action-improving uterine contractility-was not expected to improve bleeding from causes such as hysterotomy extension or arterial bleeding, the trial was powered for a prespecified subgroup analysis excluding patients with nonatonic blood loss documented in the surgeon's operative report. Documented nonatonic bleeding was defined as presence in the surgeon's operative report narrative of any of the following: hysterotomy extension, hysterotomy types other than low transverse (eg classical, T- or J-shaped), invasive or abnormally adherent placenta, placental abruption, uterine rupture, bleeding from leiomyomas, grade 3 or 4 vaginal lacerations, or cervical lacerations.
Outcome measures
| Measure |
Calcium Chloride
n=39 Participants
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=40 Participants
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Quantitative Blood Loss, Subgroup Quantitative Blood Loss (QBL, mL), Excluding Cases of Documented Non-atonic Bleeding
|
759 milliliters
Interval 592.0 to 912.0
|
922 milliliters
Interval 754.0 to 1193.0
|
Adverse Events
Calcium Chloride
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Saline Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calcium Chloride
n=60 participants at risk
1 gram of calcium chloride in total volume 60mL with sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
Saline Placebo
n=60 participants at risk
60mL sterile saline, delivered over 10 minute controlled infusion at a constant rate (360mL/hour) beginning 2 minutes after fetal delivery and 1 minute after delayed cord clamp.
|
|---|---|---|
|
Gastrointestinal disorders
New or subjective worsening in nausea
|
30.0%
18/60 • Number of events 18 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
30.0%
18/60 • Number of events 18 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
|
Gastrointestinal disorders
New or increased vomiting
|
20.0%
12/60 • Number of events 12 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
18.3%
11/60 • Number of events 11 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
|
Skin and subcutaneous tissue disorders
Intravenous line pain
|
1.7%
1/60 • Number of events 1 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
5.0%
3/60 • Number of events 3 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/60 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
10.0%
6/60 • Number of events 6 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
|
Cardiac disorders
Change in heart rate
|
1.7%
1/60 • Number of events 1 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
10.0%
6/60 • Number of events 6 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
|
Cardiac disorders
Severe range hypertension
|
0.00%
0/60 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
1.7%
1/60 • Number of events 1 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
|
Nervous system disorders
Abnormal tastes or sensations
|
0.00%
0/60 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
3.3%
2/60 • Number of events 2 • Day of cesarean delivery (and study drug administration). Adverse events were assessed formally at the conclusion of the operating room course prior to transport to the recovery unit. The clinical anesthesiologist discussed all possible side effects with the patient prior to filling out a form. (Anesthesiologist and patient blinded to allocation).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place