Trial Outcomes & Findings for Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide (NCT NCT05033041)
NCT ID: NCT05033041
Last Updated: 2025-09-11
Results Overview
Change in gastric volume (mL) determined by gastric ultrasound before and 30 minutes after administration of study drug. Gastric volumes were calculated from the cross sectional area (CSA) area using both the Perlas (Volume=27.0+14.6\*(RLD CSA (cm2)-1.28 \* age)) and the Roukhomovsky method (volume=(0.18\*RLD CSA (mm2))+(0.11\*SUP CSA (mm2)-62.4) methods.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
30 minutes after administration of study drug
Results posted on
2025-09-11
Participant Flow
72 Subjects were randomized to treatment.
Participant milestones
| Measure |
Group 1 Study Drug Metoclopramide
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
34
|
|
Overall Study
COMPLETED
|
38
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide
Baseline characteristics by cohort
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 Years
n=99 Participants
|
35 Years
n=107 Participants
|
35 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
34 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Weight (kg)
|
80.5 Kilograms
n=99 Participants
|
79.5 Kilograms
n=107 Participants
|
80 Kilograms
n=206 Participants
|
|
Body Mass In kg/m^2
|
29.8 kg/m^2
n=99 Participants
|
29.6 kg/m^2
n=107 Participants
|
29.7 kg/m^2
n=206 Participants
|
|
Gestational age (weeks)
|
39.1 Weeks
n=99 Participants
|
39.1 Weeks
n=107 Participants
|
39.1 Weeks
n=206 Participants
|
|
Gravid (number of pregnancies)
Gravid 1
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Gravid (number of pregnancies)
Gravid 2
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Gravid (number of pregnancies)
Gravid 3
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Gravid (number of pregnancies)
Greater or equal to gravid 4
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Parity
0
|
12 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Parity
1
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Parity
2
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Parity
Greater or equal to 3
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Prior cesarean deliveries
|
25 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Gastroesophageal reflux disease (GERD)
With pregnancy
|
31 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Gastroesophageal reflux disease (GERD)
Currently
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Hours since last solid ingestion (NPO)
|
12.5 Hours
n=99 Participants
|
12.9 Hours
n=107 Participants
|
12.7 Hours
n=206 Participants
|
|
Time from last liquid ingestion (hours)
|
3.3 Hours
n=99 Participants
|
3.4 Hours
n=107 Participants
|
3.3 Hours
n=206 Participants
|
|
Pretreatment estimated gastric volume (mL)
Perlas calculation
|
41 Milliliters
n=99 Participants
|
43 Milliliters
n=107 Participants
|
42 Milliliters
n=206 Participants
|
|
Pretreatment estimated gastric volume (mL)
Roukhomovsky calculation
|
53 Milliliters
n=99 Participants
|
53 Milliliters
n=107 Participants
|
53 Milliliters
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after administration of study drugPopulation: One subject in the placebo group did not have a paired ultrasound (missing pre-treatment).
Change in gastric volume (mL) determined by gastric ultrasound before and 30 minutes after administration of study drug. Gastric volumes were calculated from the cross sectional area (CSA) area using both the Perlas (Volume=27.0+14.6\*(RLD CSA (cm2)-1.28 \* age)) and the Roukhomovsky method (volume=(0.18\*RLD CSA (mm2))+(0.11\*SUP CSA (mm2)-62.4) methods.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=33 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Change in Gastric Volume (mL)
Perlas method
|
-1 Milliliters
Interval -8.0 to 6.0
|
-2 Milliliters
Interval -7.0 to 3.0
|
|
Change in Gastric Volume (mL)
Roukhomovsky formula
|
0 Milliliters
Interval -10.0 to 9.0
|
1 Milliliters
Interval -6.0 to 6.0
|
SECONDARY outcome
Timeframe: 24 hoursSubject reported intraoperative nausea during the cesarean delivery
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Subject Report of Nausea During Cesarean Section
|
14 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 72 hoursNumber of reported adverse events experienced for each group.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Adverse Events
Akathisia
|
0 Participants
|
0 Participants
|
|
Adverse Events
Extrapyramidal effect
|
0 Participants
|
0 Participants
|
|
Adverse Events
High fever
|
0 Participants
|
0 Participants
|
|
Adverse Events
Muscle stiffness
|
0 Participants
|
0 Participants
|
|
Adverse Events
Depression
|
0 Participants
|
0 Participants
|
|
Adverse Events
Fluid retention
|
0 Participants
|
0 Participants
|
|
Adverse Events
Hypoprolactinemia
|
0 Participants
|
0 Participants
|
|
Adverse Events
Hypersensitivity reaction
|
0 Participants
|
0 Participants
|
|
Adverse Events
Blood cell changes
|
0 Participants
|
0 Participants
|
|
Adverse Events
Hypernatremia
|
0 Participants
|
0 Participants
|
|
Adverse Events
Maternal resuscitation
|
0 Participants
|
0 Participants
|
|
Adverse Events
Maternal hypertension
|
1 Participants
|
1 Participants
|
|
Adverse Events
Infant gastrointestinal disturbances
|
0 Participants
|
0 Participants
|
|
Adverse Events
Infant extrapyramidial effects
|
0 Participants
|
0 Participants
|
|
Adverse Events
Infant methemoglobinemia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hoursNumber of nausea occurrences during cesarean section procedure
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Intraoperative Nausea Occurrences
|
1 Nausea occurrences
Interval 1.0 to 1.0
|
2 Nausea occurrences
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: 24 hoursTotal elapsed time in minutes from the placement of the intrathecal medications by anesthesiology team to the first experience of nausea reported by the participant.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes
|
26 Minutes
Interval 4.0 to 51.0
|
20 Minutes
Interval 7.0 to 28.0
|
SECONDARY outcome
Timeframe: 24 HoursSubject experienced vomiting episode during the cesarean delivery procedure.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Subject Experienced Vomiting During Cesarean Section
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 HoursNumber of intraoperative vomiting occurrences during the cesarean section.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Number of Intraoperative Vomiting Occurrences
|
1 Number of episodes
Interval 1.0 to 2.0
|
1 Number of episodes
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 24 HoursThe elapsed time in minutes from anesthesia team placing the intrathecal medications to the first episode of vomiting during.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Time From Intrathecal Anesthesia to Vomiting Episode in Minutes.
|
34 Minutes
Interval 8.0 to 34.0
|
26 Minutes
Interval 22.0 to 34.0
|
SECONDARY outcome
Timeframe: 24 HoursSubject received antiemetic prophylaxis of ondansetron or dexamethasone prior to the cesarean section.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Antiemetic Prophylaxis
Received ondansetron
|
35 participants
|
32 participants
|
|
Antiemetic Prophylaxis
Received dexamethasone
|
34 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 24 hoursNumber of participants who required antiemetic medications in the post anesthesia care unit
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
PACU Antiemetic Treatment (n)
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 72 hoursNumber of participants who experienced nausea after being discharged from the post anesthesia care unit
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Nausea After PACU Discharge
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 24 hoursTotal elapsed time in minutes after study drug administered to second gastric ultrasound.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Elapsed Time From Study Drug to Second Ultrasound
|
30 Minutes
Standard Deviation 1
|
30 Minutes
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 24 hoursThe cross sectional area in centimeters squared for the second gastric ultrasound which was performed 30 minutes after study medication administered
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Second Ultrasound Cross Sectional Area (cm^2)
Supine position
|
3.7 Centimeters
Interval 3.1 to 4.4
|
3.5 Centimeters
Interval 3.1 to 4.3
|
|
Second Ultrasound Cross Sectional Area (cm^2)
Right lateral displacement position
|
4.0 Centimeters
Interval 3.6 to 5.0
|
4 Centimeters
Interval 3.4 to 5.2
|
SECONDARY outcome
Timeframe: 24 hoursGastric volume in milliliters of the second ultrasound obtained 30 minutes after study drug administration
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Post Treatment Estimated Volume (mL) Second Ultrasound
Perlas calculation
|
43 Milliliters
Interval 32.0 to 55.0
|
39 Milliliters
Interval 32.0 to 59.0
|
|
Post Treatment Estimated Volume (mL) Second Ultrasound
Roukhomovsky calculation
|
55 Milliliters
Interval 38.0 to 75.0
|
54 Milliliters
Interval 36.0 to 72.0
|
SECONDARY outcome
Timeframe: 24 hoursNumber of subjects experiencing a volume greater than than 1.5 times weight in kilograms after the second gastric ultrasound 30 minutes after study medication administration.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Second Ultrasound Volume >1.5 * Weight (kg)
Perlas calculation
|
0 Participants
|
0 Participants
|
|
Second Ultrasound Volume >1.5 * Weight (kg)
Roukhomovsky calculation
|
2 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After consent obtainedThe first ultrasound of the stomach cross-sectional area in centimeters squared.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Ultrasounds
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Ultrasounds
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
First Ultrasound Stomach Cross-sectional Area (cm2)
Supine
|
3.8 centimeters squared
Interval 3.0 to 4.5
|
3.6 centimeters squared
Interval 3.3 to 4.4
|
|
First Ultrasound Stomach Cross-sectional Area (cm2)
Right lateral displacement
|
3.9 centimeters squared
Interval 3.3 to 4.9
|
4.1 centimeters squared
Interval 3.3 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After consent obtainedThe first ultrasound calculated volume greater than 1.5 times weight in kilograms.
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
First Ultrasound Volume Greater Than 1.5 * Weight (kg)
Perlas calculation
|
0 participants
|
0 participants
|
|
First Ultrasound Volume Greater Than 1.5 * Weight (kg)
Roukhomovsky calculation
|
2 participants
|
2 participants
|
POST_HOC outcome
Timeframe: 5 minutes after deliveryNeonatal APGAR scores at 1 and 5 minutes (0-poor 10 good)
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Neonatal Outcome APGAR Score
1 Minute APGAR score
|
8 scores on a scale (0 poor-10 good)
Interval 8.0 to 9.0
|
8.5 scores on a scale (0 poor-10 good)
Interval 8.0 to 9.0
|
|
Neonatal Outcome APGAR Score
5 Minute APGAR score
|
9 scores on a scale (0 poor-10 good)
Interval 9.0 to 9.0
|
9 scores on a scale (0 poor-10 good)
Interval 9.0 to 9.0
|
POST_HOC outcome
Timeframe: 5 minutes after deliveryNeonatal arterial blood gas results obtained at delivery (pH).
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Neonatal Outcomes Arterial Blood Gasses
|
7.25 pH
Interval 7.22 to 7.29
|
7.25 pH
Interval 7.22 to 7.29
|
POST_HOC outcome
Timeframe: 5 minutes after deliveryNeonatal venous blood gas post delivery (pH)
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Neonatal Outcomes Venous Blood Gas
|
7.30 pH
Interval 7.28 to 7.34
|
7.32 pH
Interval 7.29 to 7.34
|
POST_HOC outcome
Timeframe: 24 hoursNeonate required neonatal resuscitation required after cesarean section delivery
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Neonatal Outcomes: Neonatal Resuscitation
|
11 Participants
|
9 Participants
|
POST_HOC outcome
Timeframe: 24 hoursNeonate admission to the newborn intensive care unit
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Neonatal Outcomes: NICU Admission
|
2 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: After deliveryNeonatal arterial blood gas results obtained at delivery (O2 (mmHg), CO2 (mmHg).
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Neonatal Outcomes Arterial Blood Gasses
Arterial blood gas 02 (mmHg)
|
27 millimeters of mercury
Interval 19.0 to 60.0
|
32 millimeters of mercury
Interval 21.0 to 62.0
|
|
Neonatal Outcomes Arterial Blood Gasses
Arterial blood gas C02 (mmHg)
|
57 millimeters of mercury
Interval 50.0 to 60.0
|
56 millimeters of mercury
Interval 47.0 to 61.0
|
POST_HOC outcome
Timeframe: After deliveryNeonatal venous blood gas post delivery including pH, O2 (mmHg), C02 (mmHg)
Outcome measures
| Measure |
Group 1 Study Drug Metoclopramide
n=38 Participants
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 Participants
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Neonatal Outcomes Venous Blood Gas
Venous blood gas C02 (mmHg)
|
44 millimeters of mercury
Interval 41.0 to 49.0
|
45 millimeters of mercury
Interval 42.0 to 48.0
|
|
Neonatal Outcomes Venous Blood Gas
Venous blood gas oxygen (mmHg)
|
36 millimeters of mercury
Interval 27.0 to 49.0
|
41 millimeters of mercury
Interval 29.0 to 53.0
|
Adverse Events
Group 1 Study Drug Metoclopramide
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2 Study Drug Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 Study Drug Metoclopramide
n=38 participants at risk
Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide
|
Group 2 Study Drug Placebo
n=34 participants at risk
Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.9%
3/38 • Number of events 3 • 72 Hours
|
17.6%
6/34 • Number of events 6 • 72 Hours
|
|
Blood and lymphatic system disorders
Hypertension
|
7.9%
3/38 • Number of events 3 • 72 Hours
|
17.6%
6/34 • Number of events 6 • 72 Hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place