Aspiration, Cesarean Section, Pregnancy
Conditions
Keywords
Pregnancy, Gastric Volume, Ultrasound Measurement, Aspiration Prevention, Cesarean Section
Brief summary
Our objective is to compare gastric volumes (mL) between women who receive metoclopramide versus placebo prior to scheduled cesarean delivery in appropriately fasted patients. If metoclopramide is found not to reduce gastric volumes this would inform future practice guidelines for obstetric anesthesia, which currently recommends metoclopramide administration prior to cesarean deliveries. We hypothesize that metoclopramide given to women with appropriate fasting prior to cesarean delivery does not result in any clinically significant reduction in gastric volume (mL) and therefore does not provide any additional benefit for aspiration prophylaxis but may expose patients to unnecessary side effects. A secondary objective will be to evaluate if gastric volume is a significant predictor of intraoperative nausea and vomiting.
Interventions
DRUGStudy drug metoclopramide
Intravenous administration of 10 mg metoclopramide
DRUGStudy drug placebo administration
Intravenous administration of placebo (sterile normal saline)
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Research pharmacy to prepare the study medication blinding the participant, care providers, investigator and outcomes assessor.
Intervention model description
Randomized controlled blinded study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy (ASA Physical Status 2) * Age \>18 years old * Non-obese (BMI \<40 kg/m2) * Age \>18 years * Term (\>37 week) * Non-laboring parturient * Single gestation * Scheduled for a cesarean delivery and NPO
Exclusion criteria
* Systemic disease such as diabetes mellitus (type 1 or 2) * Multiple gestation * Abnormality of upper GI tract * History of GI tract related surgical procedures * Use of gastric motility medications * Active labor * Renal impairment (creatinine \>2) * Non-English speaking * Cognitively impaired * History of QT prolongation * Use of general anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastric Volume (mL) | 30 minutes after administration of study drug | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiemetic Prophylaxis | 24 Hours | Subject received antiemetic prophylaxis of ondansetron or dexamethasone prior to the cesarean section. |
| PACU Antiemetic Treatment (n) | 24 hours | Number of participants who required antiemetic medications in the post anesthesia care unit |
| Nausea After PACU Discharge | 72 hours | Number of participants who experienced nausea after being discharged from the post anesthesia care unit |
| Elapsed Time From Study Drug to Second Ultrasound | 24 hours | Total elapsed time in minutes after study drug administered to second gastric ultrasound. |
| Subject Report of Nausea During Cesarean Section | 24 hours | Subject reported intraoperative nausea during the cesarean delivery |
| Adverse Events | 72 hours | Number of reported adverse events experienced for each group. |
| Intraoperative Nausea Occurrences | 24 hours | Number of nausea occurrences during cesarean section procedure |
| Post Treatment Estimated Volume (mL) Second Ultrasound | 24 hours | Gastric volume in milliliters of the second ultrasound obtained 30 minutes after study drug administration |
| Second Ultrasound Volume >1.5 * Weight (kg) | 24 hours | Number 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. |
| Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes | 24 hours | Total elapsed time in minutes from the placement of the intrathecal medications by anesthesiology team to the first experience of nausea reported by the participant. |
| Subject Experienced Vomiting During Cesarean Section | 24 Hours | Subject experienced vomiting episode during the cesarean delivery procedure. |
| Number of Intraoperative Vomiting Occurrences | 24 Hours | Number of intraoperative vomiting occurrences during the cesarean section. |
| Time From Intrathecal Anesthesia to Vomiting Episode in Minutes. | 24 Hours | The elapsed time in minutes from anesthesia team placing the intrathecal medications to the first episode of vomiting during. |
| Second Ultrasound Cross Sectional Area (cm^2) | 24 hours | The cross sectional area in centimeters squared for the second gastric ultrasound which was performed 30 minutes after study medication administered |
Other
| Measure | Time frame | Description |
|---|---|---|
| First Ultrasound Stomach Cross-sectional Area (cm2) | After consent obtained | The first ultrasound of the stomach cross-sectional area in centimeters squared. |
| First Ultrasound Volume Greater Than 1.5 * Weight (kg) | After consent obtained | The first ultrasound calculated volume greater than 1.5 times weight in kilograms. |
Countries
United States
Participant flow
Recruitment details
72 Subjects were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Study Drug Metoclopramide Intravenous administration of 10 mg metoclopramide
Study drug metoclopramide: Intravenous administration of 4 mg metoclopramide | 38 |
| Group 2 Study Drug Placebo Intravenous administration of sterile normal saline
Study drug placebo administration: Intravenous administration of placebo (sterile normal saline) | 34 |
| Total | 72 |
Baseline characteristics
| Characteristic | Group 1 Study Drug Metoclopramide | Group 2 Study Drug Placebo | Total |
|---|---|---|---|
| Age, Continuous | 35 Years | 35 Years | 35 Years |
| Body Mass In kg/m^2 | 29.8 kg/m^2 | 29.6 kg/m^2 | 29.7 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 31 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gastroesophageal reflux disease (GERD) Currently | 4 Participants | 7 Participants | 11 Participants |
| Gastroesophageal reflux disease (GERD) With pregnancy | 31 Participants | 24 Participants | 55 Participants |
| Gestational age (weeks) | 39.1 Weeks | 39.1 Weeks | 39.1 Weeks |
| Gravid (number of pregnancies) Gravid 1 | 9 Participants | 3 Participants | 12 Participants |
| Gravid (number of pregnancies) Gravid 2 | 12 Participants | 16 Participants | 28 Participants |
| Gravid (number of pregnancies) Gravid 3 | 6 Participants | 8 Participants | 14 Participants |
| Gravid (number of pregnancies) Greater or equal to gravid 4 | 11 Participants | 7 Participants | 18 Participants |
| Hours since last solid ingestion (NPO) | 12.5 Hours | 12.9 Hours | 12.7 Hours |
| Parity 0 | 12 Participants | 4 Participants | 16 Participants |
| Parity 1 | 21 Participants | 22 Participants | 43 Participants |
| Parity 2 | 5 Participants | 5 Participants | 10 Participants |
| Parity Greater or equal to 3 | 0 Participants | 3 Participants | 3 Participants |
| Pretreatment estimated gastric volume (mL) Perlas calculation | 41 Milliliters | 43 Milliliters | 42 Milliliters |
| Pretreatment estimated gastric volume (mL) Roukhomovsky calculation | 53 Milliliters | 53 Milliliters | 53 Milliliters |
| Prior cesarean deliveries | 25 Participants | 29 Participants | 54 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 32 Participants | 68 Participants |
| Region of Enrollment United States | 38 participants | 34 participants | 72 participants |
| Sex: Female, Male Female | 38 Participants | 34 Participants | 72 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Time from last liquid ingestion (hours) | 3.3 Hours | 3.4 Hours | 3.3 Hours |
| Weight (kg) | 80.5 Kilograms | 79.5 Kilograms | 80 Kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 34 |
| other Total, other adverse events | 3 / 38 | 6 / 34 |
| serious Total, serious adverse events | 0 / 38 | 0 / 34 |
Outcome results
Primary
Change in Gastric Volume (mL)
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.
Time frame: 30 minutes after administration of study drug
Population: One subject in the placebo group did not have a paired ultrasound (missing pre-treatment).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Change in Gastric Volume (mL) | Perlas method | -1 Milliliters |
| Group 1 Study Drug Metoclopramide | Change in Gastric Volume (mL) | Roukhomovsky formula | 0 Milliliters |
| Group 2 Study Drug Placebo | Change in Gastric Volume (mL) | Perlas method | -2 Milliliters |
| Group 2 Study Drug Placebo | Change in Gastric Volume (mL) | Roukhomovsky formula | 1 Milliliters |
Comparison: Comparison of the means using two one-sided t tests (TOST)p-value: 0.001t-test, 1 sided
Secondary
Adverse Events
Number of reported adverse events experienced for each group.
Time frame: 72 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Adverse Events | Hypoprolactinemia | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Blood cell changes | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Akathisia | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Hypernatremia | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Muscle stiffness | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Maternal resuscitation | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Extrapyramidal effect | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Maternal hypertension | 1 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Fluid retention | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Infant gastrointestinal disturbances | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Depression | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Infant extrapyramidial effects | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Hypersensitivity reaction | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | Infant methemoglobinemia | 0 Participants |
| Group 1 Study Drug Metoclopramide | Adverse Events | High fever | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Infant methemoglobinemia | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | High fever | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Muscle stiffness | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Depression | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Fluid retention | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Akathisia | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Extrapyramidal effect | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Hypoprolactinemia | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Hypersensitivity reaction | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Blood cell changes | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Hypernatremia | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Maternal resuscitation | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Maternal hypertension | 1 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Infant gastrointestinal disturbances | 0 Participants |
| Group 2 Study Drug Placebo | Adverse Events | Infant extrapyramidial effects | 0 Participants |
Secondary
Antiemetic Prophylaxis
Subject received antiemetic prophylaxis of ondansetron or dexamethasone prior to the cesarean section.
Time frame: 24 Hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Antiemetic Prophylaxis | Received ondansetron | 35 participants |
| Group 1 Study Drug Metoclopramide | Antiemetic Prophylaxis | Received dexamethasone | 34 participants |
| Group 2 Study Drug Placebo | Antiemetic Prophylaxis | Received ondansetron | 32 participants |
| Group 2 Study Drug Placebo | Antiemetic Prophylaxis | Received dexamethasone | 32 participants |
Secondary
Elapsed Time From Study Drug to Second Ultrasound
Total elapsed time in minutes after study drug administered to second gastric ultrasound.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Elapsed Time From Study Drug to Second Ultrasound | 30 Minutes | Standard Deviation 1 |
| Group 2 Study Drug Placebo | Elapsed Time From Study Drug to Second Ultrasound | 30 Minutes | Standard Deviation 2 |
Secondary
Intraoperative Nausea Occurrences
Number of nausea occurrences during cesarean section procedure
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Intraoperative Nausea Occurrences | 1 Nausea occurrences |
| Group 2 Study Drug Placebo | Intraoperative Nausea Occurrences | 2 Nausea occurrences |
Secondary
Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes
Total elapsed time in minutes from the placement of the intrathecal medications by anesthesiology team to the first experience of nausea reported by the participant.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes | 26 Minutes |
| Group 2 Study Drug Placebo | Intraoperative Nausea Time From Intrathecal Anesthesia to Nausea Episode in Minutes | 20 Minutes |
Secondary
Nausea After PACU Discharge
Number of participants who experienced nausea after being discharged from the post anesthesia care unit
Time frame: 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Nausea After PACU Discharge | 3 Participants |
| Group 2 Study Drug Placebo | Nausea After PACU Discharge | 6 Participants |
Secondary
Number of Intraoperative Vomiting Occurrences
Number of intraoperative vomiting occurrences during the cesarean section.
Time frame: 24 Hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Number of Intraoperative Vomiting Occurrences | 1 Number of episodes |
| Group 2 Study Drug Placebo | Number of Intraoperative Vomiting Occurrences | 1 Number of episodes |
Secondary
PACU Antiemetic Treatment (n)
Number of participants who required antiemetic medications in the post anesthesia care unit
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | PACU Antiemetic Treatment (n) | 5 Participants |
| Group 2 Study Drug Placebo | PACU Antiemetic Treatment (n) | 1 Participants |
Secondary
Post Treatment Estimated Volume (mL) Second Ultrasound
Gastric volume in milliliters of the second ultrasound obtained 30 minutes after study drug administration
Time frame: 24 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Post Treatment Estimated Volume (mL) Second Ultrasound | Perlas calculation | 43 Milliliters |
| Group 1 Study Drug Metoclopramide | Post Treatment Estimated Volume (mL) Second Ultrasound | Roukhomovsky calculation | 55 Milliliters |
| Group 2 Study Drug Placebo | Post Treatment Estimated Volume (mL) Second Ultrasound | Perlas calculation | 39 Milliliters |
| Group 2 Study Drug Placebo | Post Treatment Estimated Volume (mL) Second Ultrasound | Roukhomovsky calculation | 54 Milliliters |
Secondary
Second Ultrasound Cross Sectional Area (cm^2)
The cross sectional area in centimeters squared for the second gastric ultrasound which was performed 30 minutes after study medication administered
Time frame: 24 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Second Ultrasound Cross Sectional Area (cm^2) | Supine position | 3.7 Centimeters |
| Group 1 Study Drug Metoclopramide | Second Ultrasound Cross Sectional Area (cm^2) | Right lateral displacement position | 4.0 Centimeters |
| Group 2 Study Drug Placebo | Second Ultrasound Cross Sectional Area (cm^2) | Supine position | 3.5 Centimeters |
| Group 2 Study Drug Placebo | Second Ultrasound Cross Sectional Area (cm^2) | Right lateral displacement position | 4 Centimeters |
Secondary
Second Ultrasound Volume >1.5 * Weight (kg)
Number 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.
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Second Ultrasound Volume >1.5 * Weight (kg) | Perlas calculation | 0 Participants |
| Group 1 Study Drug Metoclopramide | Second Ultrasound Volume >1.5 * Weight (kg) | Roukhomovsky calculation | 2 Participants |
| Group 2 Study Drug Placebo | Second Ultrasound Volume >1.5 * Weight (kg) | Perlas calculation | 0 Participants |
| Group 2 Study Drug Placebo | Second Ultrasound Volume >1.5 * Weight (kg) | Roukhomovsky calculation | 3 Participants |
Secondary
Subject Experienced Vomiting During Cesarean Section
Subject experienced vomiting episode during the cesarean delivery procedure.
Time frame: 24 Hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Subject Experienced Vomiting During Cesarean Section | 3 Participants |
| Group 2 Study Drug Placebo | Subject Experienced Vomiting During Cesarean Section | 5 Participants |
Secondary
Subject Report of Nausea During Cesarean Section
Subject reported intraoperative nausea during the cesarean delivery
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Subject Report of Nausea During Cesarean Section | 14 Participants |
| Group 2 Study Drug Placebo | Subject Report of Nausea During Cesarean Section | 18 Participants |
Secondary
Time From Intrathecal Anesthesia to Vomiting Episode in Minutes.
The elapsed time in minutes from anesthesia team placing the intrathecal medications to the first episode of vomiting during.
Time frame: 24 Hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Time From Intrathecal Anesthesia to Vomiting Episode in Minutes. | 34 Minutes |
| Group 2 Study Drug Placebo | Time From Intrathecal Anesthesia to Vomiting Episode in Minutes. | 26 Minutes |
Other Pre-specified
First Ultrasound Stomach Cross-sectional Area (cm2)
The first ultrasound of the stomach cross-sectional area in centimeters squared.
Time frame: After consent obtained
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | First Ultrasound Stomach Cross-sectional Area (cm2) | Supine | 3.8 centimeters squared |
| Group 1 Study Drug Metoclopramide | First Ultrasound Stomach Cross-sectional Area (cm2) | Right lateral displacement | 3.9 centimeters squared |
| Group 2 Study Drug Placebo | First Ultrasound Stomach Cross-sectional Area (cm2) | Supine | 3.6 centimeters squared |
| Group 2 Study Drug Placebo | First Ultrasound Stomach Cross-sectional Area (cm2) | Right lateral displacement | 4.1 centimeters squared |
Other Pre-specified
First Ultrasound Volume Greater Than 1.5 * Weight (kg)
The first ultrasound calculated volume greater than 1.5 times weight in kilograms.
Time frame: After consent obtained
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | First Ultrasound Volume Greater Than 1.5 * Weight (kg) | Perlas calculation | 0 participants |
| Group 1 Study Drug Metoclopramide | First Ultrasound Volume Greater Than 1.5 * Weight (kg) | Roukhomovsky calculation | 2 participants |
| Group 2 Study Drug Placebo | First Ultrasound Volume Greater Than 1.5 * Weight (kg) | Perlas calculation | 0 participants |
| Group 2 Study Drug Placebo | First Ultrasound Volume Greater Than 1.5 * Weight (kg) | Roukhomovsky calculation | 2 participants |
Post Hoc
Neonatal Outcome APGAR Score
Neonatal APGAR scores at 1 and 5 minutes (0-poor 10 good)
Time frame: 5 minutes after delivery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Neonatal Outcome APGAR Score | 1 Minute APGAR score | 8 scores on a scale (0 poor-10 good) |
| Group 1 Study Drug Metoclopramide | Neonatal Outcome APGAR Score | 5 Minute APGAR score | 9 scores on a scale (0 poor-10 good) |
| Group 2 Study Drug Placebo | Neonatal Outcome APGAR Score | 1 Minute APGAR score | 8.5 scores on a scale (0 poor-10 good) |
| Group 2 Study Drug Placebo | Neonatal Outcome APGAR Score | 5 Minute APGAR score | 9 scores on a scale (0 poor-10 good) |
Post Hoc
Neonatal Outcomes Arterial Blood Gasses
Neonatal arterial blood gas results obtained at delivery (O2 (mmHg), CO2 (mmHg).
Time frame: After delivery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Neonatal Outcomes Arterial Blood Gasses | Arterial blood gas 02 (mmHg) | 27 millimeters of mercury |
| Group 1 Study Drug Metoclopramide | Neonatal Outcomes Arterial Blood Gasses | Arterial blood gas C02 (mmHg) | 57 millimeters of mercury |
| Group 2 Study Drug Placebo | Neonatal Outcomes Arterial Blood Gasses | Arterial blood gas 02 (mmHg) | 32 millimeters of mercury |
| Group 2 Study Drug Placebo | Neonatal Outcomes Arterial Blood Gasses | Arterial blood gas C02 (mmHg) | 56 millimeters of mercury |
Post Hoc
Neonatal Outcomes Arterial Blood Gasses
Neonatal arterial blood gas results obtained at delivery (pH).
Time frame: 5 minutes after delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Neonatal Outcomes Arterial Blood Gasses | 7.25 pH |
| Group 2 Study Drug Placebo | Neonatal Outcomes Arterial Blood Gasses | 7.25 pH |
Post Hoc
Neonatal Outcomes: Neonatal Resuscitation
Neonate required neonatal resuscitation required after cesarean section delivery
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Neonatal Outcomes: Neonatal Resuscitation | 11 Participants |
| Group 2 Study Drug Placebo | Neonatal Outcomes: Neonatal Resuscitation | 9 Participants |
Post Hoc
Neonatal Outcomes: NICU Admission
Neonate admission to the newborn intensive care unit
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Neonatal Outcomes: NICU Admission | 2 Participants |
| Group 2 Study Drug Placebo | Neonatal Outcomes: NICU Admission | 0 Participants |
Post Hoc
Neonatal Outcomes Venous Blood Gas
Neonatal venous blood gas post delivery (pH)
Time frame: 5 minutes after delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 Study Drug Metoclopramide | Neonatal Outcomes Venous Blood Gas | 7.30 pH |
| Group 2 Study Drug Placebo | Neonatal Outcomes Venous Blood Gas | 7.32 pH |
Post Hoc
Neonatal Outcomes Venous Blood Gas
Neonatal venous blood gas post delivery including pH, O2 (mmHg), C02 (mmHg)
Time frame: After delivery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1 Study Drug Metoclopramide | Neonatal Outcomes Venous Blood Gas | Venous blood gas oxygen (mmHg) | 36 millimeters of mercury |
| Group 1 Study Drug Metoclopramide | Neonatal Outcomes Venous Blood Gas | Venous blood gas C02 (mmHg) | 44 millimeters of mercury |
| Group 2 Study Drug Placebo | Neonatal Outcomes Venous Blood Gas | Venous blood gas oxygen (mmHg) | 41 millimeters of mercury |
| Group 2 Study Drug Placebo | Neonatal Outcomes Venous Blood Gas | Venous blood gas C02 (mmHg) | 45 millimeters of mercury |