Induction of Labor
Conditions
Keywords
induction of labor, pitocin, foley bulb
Brief summary
The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.
Interventions
DRUGpitocin
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a singleton pregnancy 2. Term pregnancy (\> 37 weeks gestation) 3. Age ≥ 18 years 4. Bishop score \< 5 5. Contractions \< 6/hr 6. Reassuring fetal heart tracing
Exclusion criteria
1. Rupture of membranes 2. Antepartum bleeding 3. Fetal death 4. Placenta previa or low lying placenta 5. Active genital herpes infection 6. Previous use of an induction or preinduction agent during the current pregnancy 7. EFW \>4500 grams 8. Non reassuring fetal testing 9. Inability to pass foley through cervix 10. Prior cesarean section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the Second Stage of Labor | foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days) | The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus. |
| Time to Delivery | foley bulb placement until delivery (during admission for delivery, up to approximately 4 days) | Time from foley balloon placement until neonate delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Foley Expulsion or Removal | foley bulb placement until removal, up to 10 hours | Time from foley balloon placement until the expulsion or removal of the foley balloon. |
| Incidence of Uterine Hyperstimulation | during admission for delivery, up to approximately 4 days | Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes. |
| Rate of Cesarean Delivery | during admission for delivery, up to approximately 4 days | Number of participants having a cesarean delivery |
| Neonatal Outcome: Placental Abruption | during admission for delivery, up to approximately 4 days | number of participants with placental abruption |
| Neonatal Outcome: Late Fetal Heart Rate Decelerations | during admission for delivery, up to approximately 4 days | Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction. |
| Neonatal Outcome: Birthweight | at time of birth (0 to 1 hour) | — |
| Time to Active Labor | during admission for delivery, up to approximately 4 days | Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women. |
Participant flow
Pre-assignment details
121 subjects enrolled. Of the 121 subjects 2 were screen failures and 2 subject were excluded after consent due to meeting exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Foley Bulb Induction With Low Dose Pitocin Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin | 57 |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin | 59 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Total | Foley Bulb Induction With Low Dose Pitocin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 59 Participants | 116 Participants | 57 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 61 Participants | 29 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 | 12 Participants | 25 Participants | 13 Participants |
| Race (NIH/OMB) White | 14 Participants | 27 Participants | 13 Participants |
| Region of Enrollment United States | 59 participants | 116 participants | 57 participants |
| Sex: Female, Male Female | 59 Participants | 116 Participants | 57 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 59 |
| serious Total, serious adverse events | 0 / 57 | 0 / 59 |
Outcome results
Primary
Time to Delivery
Time from foley balloon placement until neonate delivery
Time frame: foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Foley Bulb Induction With Low Dose Pitocin | Time to Delivery | 23.7 hours |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Time to Delivery | 19.1 hours |
Primary
Time to the Second Stage of Labor
The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.
Time frame: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Foley Bulb Induction With Low Dose Pitocin | Time to the Second Stage of Labor | 18.2 hours |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Time to the Second Stage of Labor | 14.6 hours |
Secondary
Incidence of Uterine Hyperstimulation
Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.
Time frame: during admission for delivery, up to approximately 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Foley Bulb Induction With Low Dose Pitocin | Incidence of Uterine Hyperstimulation | 7 participants |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Incidence of Uterine Hyperstimulation | 11 participants |
Secondary
Neonatal Outcome: Birthweight
Time frame: at time of birth (0 to 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foley Bulb Induction With Low Dose Pitocin | Neonatal Outcome: Birthweight | 3065 gram | Standard Deviation 530 |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Neonatal Outcome: Birthweight | 3180 gram | Standard Deviation 511 |
Secondary
Neonatal Outcome: Late Fetal Heart Rate Decelerations
Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.
Time frame: during admission for delivery, up to approximately 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Foley Bulb Induction With Low Dose Pitocin | Neonatal Outcome: Late Fetal Heart Rate Decelerations | 14 neonates |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Neonatal Outcome: Late Fetal Heart Rate Decelerations | 8 neonates |
Secondary
Neonatal Outcome: Placental Abruption
number of participants with placental abruption
Time frame: during admission for delivery, up to approximately 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Foley Bulb Induction With Low Dose Pitocin | Neonatal Outcome: Placental Abruption | 0 participants |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Neonatal Outcome: Placental Abruption | 0 participants |
Secondary
Rate of Cesarean Delivery
Number of participants having a cesarean delivery
Time frame: during admission for delivery, up to approximately 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Foley Bulb Induction With Low Dose Pitocin | Rate of Cesarean Delivery | 22 participants |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Rate of Cesarean Delivery | 20 participants |
Secondary
Time to Active Labor
Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.
Time frame: during admission for delivery, up to approximately 4 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Foley Bulb Induction With Low Dose Pitocin | Time to Active Labor | 9.3 hours |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Time to Active Labor | 12.2 hours |
Secondary
Time to Foley Expulsion or Removal
Time from foley balloon placement until the expulsion or removal of the foley balloon.
Time frame: foley bulb placement until removal, up to 10 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Foley Bulb Induction With Low Dose Pitocin | Time to Foley Expulsion or Removal | 4.5 hours |
| Foley Bulb With Standard Incremental Pitocin Infusion Protocol | Time to Foley Expulsion or Removal | 5.6 hours |