Primary outcomeCount of participants· Until delivery
Number of Participants Delivered by Cesarean
| Group | Value (Participants) |
|---|---|
| High-dose | 3 |
| Low-dose | 3 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataA Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity
Short name HILIO-PILOT
NCTNCT05289869 (opens ClinicalTrials.gov in a new tab)Other id2021H0432
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 20 participants (actual)
- Sponsor
- Ohio State University · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 6 Apr 2022
- Primary completion
- 18 Sept 2022
- Completion
- 28 Oct 2022
- First posted
- 22 Mar 2022
- Last update posted
- 29 Nov 2023
- Conditions
- Pregnant Patients With Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20222023
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Pregnant patients with obesity are more likely to undergo induction of labor and have a higher risk of failed induction compared to patients with normal weight. The association between maternal obesity and labor dysfunction leading to cesarean delivery is poorly understood. Oxytocin is the mostly common medication used in induction of labor, yet optimal dosing of this medication is unknown. Studies have suggested that patients with obesity may be less responsive to oxytocin. This trial will compare a high and low dose oxytocin dosing regimen for the induction of labor in women with obesity.
Interventions
- High-dose oxytocinDrug
- Low-dose oxytocinDrug
Arms2
Experimental
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.
Experimental
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants Delivered by Cesarean
Time frame · Until delivery
Secondary outcomes(16)
Duration of Time From Start of Induction to Delivery
Time frame · From start of induction to delivery
Registry description
Time from start of induction with medication or Foley catheter until delivery
Duration of the First Stage of Labor
Time frame · From start of induction to delivery
Registry description
Time from start of labor to complete dilation
Occurrence of Tachysystole
Time frame · From start of induction to delivery
Registry description
Defined as more than 5 contractions in 10 minutes averaged over 30 minutes
Incidence of Uterine Rupture
Time frame · From start of induction to delivery
Registry description
Defined as a complete disruption of all uterine layers including serosa
Incidence of Clinical Chorioamnionitis
Time frame · From start of induction thorough delivery
Registry description
Defined based on clinical diagnosis as documented by the clinical care team
Incidence of Postpartum Maternal Infectious Morbidity
Time frame · Within 6 weeks following delivery
Registry description
Defined as a composite outcome of endomyometritis, puerperal sepsis, or surgical site infection as documented in the the clinical record
Incidence of Maternal Death
Time frame · Within 6 weeks of delivery
Incidence of Immediate Postpartum Hemorrhage
Time frame · Within 24 hours of delivery
Registry description
Defined as \>1000 mL of blood loss within 24 hours of delivery
Incidence of Maternal Blood Transfusion
Time frame · From randomization through hospital discharge up to 6 weeks portpartum
Registry description
Defined as need for blood transfusion
Incidence of Maternal ICU Admission
Time frame · From randomization through 6 weeks postpartum
Incidence of Composite Neonatal Morbidity Outcomes
Time frame · Within 6 weeks of delivery
Registry description
Apgar score \<5 at 5 min, arterial cord pH \<7.0 or base deficit \>12 mmol/dL, perinatal death
Incidence of NICU Admission
Time frame · Within 6 weeks of delivery
Maternal Length of Stay
Time frame · Within 6 weeks of delivery
Registry description
Duration of hospitalization for delivery
Neonatal Length of Stay
Time frame · Within 6 weeks of delivery
Registry description
Duration of birth hospitalization
Perception of the Labor, Birth, and Postpartum Experience
Time frame · Assessed within 12-96 hours after delivery
Registry description
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.
Labor Agentry Score
Time frame · Assessed within 12-96 hours after delivery
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMedian· From start of induction to delivery
Duration of Time From Start of Induction to Delivery
| Group | Value (hours) |
|---|---|
| High-dose | 22.6 |
| Low-dose | 24.7 |
Secondary outcomeMedian· From start of induction to delivery
Duration of the First Stage of Labor
| Group | Value (hours) |
|---|---|
| High-dose | 17.3 |
| Low-dose | 21.4 |
Secondary outcomeCount of participants· From start of induction to delivery
Occurrence of Tachysystole
| Group | Value (Participants) |
|---|---|
| High-dose | 5 |
| Low-dose | 3 |
Secondary outcomeCount of participants· From start of induction to delivery
Incidence of Uterine Rupture
| Group | Value (Participants) |
|---|---|
| High-dose | 0 |
| Low-dose | 0 |
Secondary outcomeCount of participants· From start of induction thorough delivery
Incidence of Clinical Chorioamnionitis
| Group | Value (Participants) |
|---|---|
| High-dose | 3 |
| Low-dose | 1 |
Secondary outcomeCount of participants· Within 6 weeks following delivery
Incidence of Postpartum Maternal Infectious Morbidity
| Group | Value (Participants) |
|---|---|
| High-dose | 0 |
| Low-dose | 0 |
Secondary outcomeCount of participants· Within 6 weeks of delivery
Incidence of Maternal Death
| Group | Value (Participants) |
|---|---|
| High-dose | 0 |
| Low-dose | 0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| High-doseGroup randomized to high-dose oxytocin regimen | 0 / 10 | 0 / 10 | 0 / 10 |
| Low-doseGroup randomized to low-dose oxytocin regimen | 0 / 10 | 0 / 10 | 3 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 50 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Nulliparity
2. Maternal age \>18 years
3. Gestational age ≥37w0d
4. Induction of labor, defined as initiation of labor with medication or intracervical Foley catheter in a patient without observed spontaneous cervical change and \<6 contractions per hour (average of one contraction every 10 minutes) at the time of initial presentation. Women with prelabor rupture of membranes (PROM) can be included if the other criteria are also met with regards to cervical dilation and contractions.
5. Singleton gestation
6. Cephalic presentation
7. Indication for oxytocin use in the first stage of labor
8. No contraindication to labor or vaginal delivery
9. Pre-pregnancy BMI ≥30 kg/m2 based on patient report and confirmed by pre-pregnancy or first trimester weight as recorded in the medical record
10. Cervical dilation ≤4 cm at time of initiation of induction
Exclusion Criteria:
1. Fetal demise
2. Major fetal congenital malformation or known chromosomal abnormality
3. Prior uterine surgery (e.g., cesarean, myomectomy)
4. Non-reassuring fetal wellbeing as indication for induction
5. Intraamniotic infection suspected or diagnosed prior to randomization
6. Non-English
7. Multifetal gestation
8. Gestational age \<37 weeks
9. Spontaneous labor
10. Cervical dilation \> 4 cm at initiation of induction
11. Initiation of oxytocin in the second stage of labor
12. Use of oxytocin prior to randomization or planned use of oxytocin with foley catheter for cervical ripening
13. Fetal malpresentation
14. Estimated fetal weight \>4500 g in a patient with diabetes, or estimated fetal weight \>5000 g in a non-diabetic patient
15. Abnormal placentation (e.g. previa, suspected placenta accreta spectrum)
16. Physician/provider or patient refusal
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