Trial Outcomes & Findings for Oxytocin Dosage to Decrease Induction Duration (NCT NCT03140488)
NCT ID: NCT03140488
Last Updated: 2022-12-20
Results Overview
Number of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
Start of induction to Delivery
Results posted on
2022-12-20
Participant Flow
Participant milestones
| Measure |
Lean-Control
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Lean-Intervention
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
Obese-Control
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Obese-Intervention
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin Dosage to Decrease Induction Duration
Baseline characteristics by cohort
| Measure |
Lean-Control
n=35 Participants
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Lean-Intervention
n=35 Participants
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
Obese-Control
n=35 Participants
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Obese-Intervention
n=35 Participants
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
28.89 years
STANDARD_DEVIATION 5.76 • n=5 Participants
|
28.54 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
30.63 years
STANDARD_DEVIATION 5.31 • n=5 Participants
|
26.80 years
STANDARD_DEVIATION 4.51 • n=4 Participants
|
28.71 years
STANDARD_DEVIATION 5.33 • n=21 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
140 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
35 participants
n=5 Participants
|
35 participants
n=4 Participants
|
140 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Start of induction to DeliveryNumber of minutes from induction of labor with oxytocin infusion to delivery of infant, no maximum amount of time specified.
Outcome measures
| Measure |
Lean-Control
n=29 Participants
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Lean-Intervention
n=33 Participants
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
Obese-Control
n=30 Participants
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Obese-Intervention
n=34 Participants
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
|---|---|---|---|---|
|
Length of Time to Delivery
|
796 minutes
Standard Deviation 411
|
694 minutes
Standard Deviation 466
|
715 minutes
Standard Deviation 497
|
762 minutes
Standard Deviation 594
|
SECONDARY outcome
Timeframe: Start of induction to Deliveryrate measured in milliunits/minute during induction of labour, no time limit applied.
Outcome measures
| Measure |
Lean-Control
n=26 Participants
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Lean-Intervention
n=20 Participants
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
Obese-Control
n=22 Participants
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Obese-Intervention
n=20 Participants
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
|---|---|---|---|---|
|
Maximum Oxytocin Infusion Rate
|
14.85 milliunits per minute
Standard Deviation 7.16
|
33.00 milliunits per minute
Standard Deviation 25.64
|
17.14 milliunits per minute
Standard Deviation 10.99
|
39.60 milliunits per minute
Standard Deviation 21.09
|
SECONDARY outcome
Timeframe: Start of induction to DeliveryIf terbutaline was injected during labor to decrease number or strength of contraction
Outcome measures
| Measure |
Lean-Control
n=35 Participants
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Lean-Intervention
n=35 Participants
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
Obese-Control
n=35 Participants
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Obese-Intervention
n=35 Participants
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
|---|---|---|---|---|
|
Number of Participants With Terbutaline Use
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Start of induction to Deliverytotal number of patients who undergo cesarean delivery
Outcome measures
| Measure |
Lean-Control
n=35 Participants
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Lean-Intervention
n=35 Participants
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
Obese-Control
n=35 Participants
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Obese-Intervention
n=35 Participants
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
|---|---|---|---|---|
|
Rate of Cesarean Delivery
|
5 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Start of induction to DeliveryNumber of patients who undergo cesarean delivery due to labor arrest/ failed induction
Outcome measures
| Measure |
Lean-Control
n=35 Participants
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Lean-Intervention
n=35 Participants
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
Obese-Control
n=35 Participants
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Obese-Intervention
n=35 Participants
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
|---|---|---|---|---|
|
Rate of Cesarean Delivery for Labor Arrest
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At deliveryBlood loss in milliliters
Outcome measures
| Measure |
Lean-Control
n=35 Participants
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Lean-Intervention
n=35 Participants
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
Obese-Control
n=35 Participants
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
|
Obese-Intervention
n=35 Participants
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
|
|---|---|---|---|---|
|
Maternal Blood Loss
|
391.14 milliliters
Standard Deviation 207.96
|
358.57 milliliters
Standard Deviation 166.49
|
404.29 milliliters
Standard Deviation 226.99
|
491.43 milliliters
Standard Deviation 342.89
|
SECONDARY outcome
Timeframe: 5 minutes after birth5 minute Apgar Score \<7 \*Apgar is an acronym for which each criterion is given a minimum of 0 and maximum of 2 points: Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), Respiration
Outcome measures
| Measure |
Lean-Control
n=35 Participants
1\) Control group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
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Lean-Intervention
n=35 Participants
2\) Intervention group: Lean cohort: BMI ≤25, at \<20 weeks gestation or BMI ≤28 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
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Obese-Control
n=35 Participants
3\) Control group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, low dose oxytocin protocol
Low dose oxytocin regimen (the standard at Banner University Labor and Delivery, as well as across the United States): 30 units in 500cc 0.9% normal saline bag (60 milliunit/cc). Starting rate would be 2 milliunit/minute, or 2cc/hour. The medication will be increased by 2 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 20 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
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Obese-Intervention
n=35 Participants
4\) Intervention group: Obese cohort: BMI ≥30, at \<20 weeks gestation or BMI ≥35 at a term gestation, high dose oxytocin protocol
High dose oxytocin regimen (endorsed by American College of Obstetricians and Gynecologists): 90 units in 500cc 0.9% normal saline bag (180 milliunit/cc). Starting rate would be 6 milliunit/minute, or 2cc/hour. The medication will be increased by 6 milliunit/minute = 2cc/hr every 30 minutes until adequacy of contraction or cervical change. At 60 milliunit/minute = 20cc/hr, provider will assess patient for eligibility to continue to increase oxytocin dosage.
Oxytocin: Patients will be randomized to low dose or high dose oxytocin for induction of labor.
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|---|---|---|---|---|
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Number of Neonates With Apgar Score <7
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0 Participants
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3 Participants
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0 Participants
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1 Participants
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Adverse Events
Lean-Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lean-Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese-Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese-Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place