Trial Outcomes & Findings for A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity (NCT NCT05289869)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Until delivery

Results posted on

2023-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	High-dose Oxytocin Regimen Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. High-dose oxytocin: Starting dose 6 mU/min and increased by 6 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.	Low-dose Oxytocin Regimen Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers. Low-dose oxytocin: Starting dose 2 mU/min and increased by 2 mU/min every 30 minutes until adequate contractions achieved, at the discretion of the obstetric providers.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen	Total n=20 Participants Total of all reporting groups
Age, Continuous Maternal age	25.5 years STANDARD_DEVIATION 4.53 • n=5 Participants	26.9 years STANDARD_DEVIATION 6.06 • n=7 Participants	26.2 years STANDARD_DEVIATION 5.26 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 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 Race/ethnicity · Non-Hispanic Black	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Non-Hispanic White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Hispanic	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Delivery BMI, Continuous	41.8 kg/m^2 n=5 Participants	41.4 kg/m^2 n=7 Participants	41.6 kg/m^2 n=5 Participants
Delivery BMI ≥40	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Gestational age, continuous	38.0 weeks n=5 Participants	39.1 weeks n=7 Participants	38.7 weeks n=5 Participants
Admission Bishop score <5	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Maximum oxytocin dose	16.5 mu/min n=5 Participants	10 mu/min n=7 Participants	13 mu/min n=5 Participants

PRIMARY outcome

Timeframe: Until delivery

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Number of Participants Delivered by Cesarean	3 Participants	3 Participants

SECONDARY outcome

Timeframe: From start of induction to delivery

Time from start of induction with medication or Foley catheter until delivery

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Duration of Time From Start of Induction to Delivery	22.6 hours Interval 15.9 to 30.3	24.7 hours Interval 21.2 to 34.7

SECONDARY outcome

Timeframe: From start of induction to delivery

Time from start of labor to complete dilation

Outcome measures

Outcome measures
Measure	High-dose n=8 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=7 Participants Group randomized to low-dose oxytocin regimen
Duration of the First Stage of Labor	17.3 hours Interval 14.2 to 28.6	21.4 hours Interval 16.3 to 26.6

SECONDARY outcome

Timeframe: From start of induction to delivery

Defined as more than 5 contractions in 10 minutes averaged over 30 minutes

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Occurrence of Tachysystole	5 Participants	3 Participants

SECONDARY outcome

Timeframe: From start of induction to delivery

Defined as a complete disruption of all uterine layers including serosa

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Incidence of Uterine Rupture	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From start of induction thorough delivery

Defined based on clinical diagnosis as documented by the clinical care team

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Incidence of Clinical Chorioamnionitis	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 6 weeks following delivery

Defined as a composite outcome of endomyometritis, puerperal sepsis, or surgical site infection as documented in the the clinical record

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Incidence of Postpartum Maternal Infectious Morbidity	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 6 weeks of delivery

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Incidence of Maternal Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 24 hours of delivery

Defined as \>1000 mL of blood loss within 24 hours of delivery

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Incidence of Immediate Postpartum Hemorrhage	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization through hospital discharge up to 6 weeks portpartum

Defined as need for blood transfusion

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Incidence of Maternal Blood Transfusion	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization through 6 weeks postpartum

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Incidence of Maternal ICU Admission	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 6 weeks of delivery

Apgar score \<5 at 5 min, arterial cord pH \<7.0 or base deficit \>12 mmol/dL, perinatal death

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Incidence of Composite Neonatal Morbidity Outcomes	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 6 weeks of delivery

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Incidence of NICU Admission	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Within 6 weeks of delivery

Duration of hospitalization for delivery

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Maternal Length of Stay	3 days Interval 2.0 to 5.0	3 days Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: Within 6 weeks of delivery

Duration of birth hospitalization

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=10 Participants Group randomized to low-dose oxytocin regimen
Neonatal Length of Stay	2 days Interval 1.0 to 3.0	2 days Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: Assessed within 12-96 hours after delivery

Patient perception as measured using the validated Childbirth Perception Scale. This is a 12-item instrument developed to assess a patient's perception of the labor and delivery experience. Each item is formatted on a four-point scale ranging from 0 to 3. The overall range in total score is 1-36 with higher scores indicating a less positive perception.

Outcome measures

Outcome measures
Measure	High-dose n=10 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=9 Participants Group randomized to low-dose oxytocin regimen
Perception of the Labor, Birth, and Postpartum Experience	14 score on a scale Interval 9.0 to 16.0	9 score on a scale Interval 7.0 to 14.0

SECONDARY outcome

Timeframe: Assessed within 12-96 hours after delivery

Patient perception of labor agentry as measured using validated Labor Agentry Scale. This 29-item tool was developed to assess a patient's expectancies and experiences with control in labor. Each item is scored 1 to 7. Overall total score can range from 29-201 with higher scores indicated greater perceived control during childbirth.

Outcome measures

Outcome measures
Measure	High-dose n=8 Participants Group randomized to high-dose oxytocin regimen	Low-dose n=9 Participants Group randomized to low-dose oxytocin regimen
Labor Agentry Score	139.5 score on a scale Interval 138.0 to 174.0	185 score on a scale Interval 169.0 to 190.0

Adverse Events

High-dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low-dose

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	High-dose n=10 participants at risk Group randomized to high-dose oxytocin regimen	Low-dose n=10 participants at risk Group randomized to low-dose oxytocin regimen
Investigations Hospital readmission	0.00% 0/10 • 6 weeks following delivery An adverse event (AE) will be defined as any untoward or unfavorable medical occurrence in a study participant, whether or not considered related to the subject's participation in the research.	30.0% 3/10 • Number of events 3 • 6 weeks following delivery An adverse event (AE) will be defined as any untoward or unfavorable medical occurrence in a study participant, whether or not considered related to the subject's participation in the research.

Additional Information

Heather Frey, MD, MSCI

The Ohio State University

Phone: 614-688-6798

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place