Labor; Forced or Induced, Affecting Fetus or Newborn
Conditions
Keywords
induction, Foley catheter, oxytocin
Brief summary
The overall purpose of this study is to determine if adding oxytocin to a Foley catheter for induction of labor will increase the rate of delivery within 24 hours stratified by parity.
Detailed description
This is a multi-center, open-label, randomized study. Women with a singleton, vertex gestation between 24-42 weeks gestations presenting for labor induction will be offered participation in this study. Patients who receive prenatal care at Christiana Care may be approached if an induction of labor is scheduled and consented at their prenatal visit. All indications for induction will be included except those specifically mentioned as exclusion criteria. Any contraindication for vaginal delivery would exclude the subject. After informed consent is obtained, the Foley catheter will be placed and the subject will be randomized to receive oxytocin (study group) or not (control group). After Foley catheter removal or expulsion, the remainder of the induction course was left to the discretion of the primary provider. Prior to randomization, the subject will be placed into the nulliparous or multiparous group.
Interventions
DRUGOxytocin
Sponsors
Thomas Jefferson University
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age greater than 18 years * Pregnant, singleton gestation, vertex presentation * Admitted for induction of labor between gestational ages 24 - 42 weeks * Bishop score \<6
Exclusion criteria
* Multiple gestation * Non-vertex presentation * Latex allergy or latex-free Foley catheter to be placed * Fetal death * Anomalous fetus * Placenta/vasa previa * Placental abruption (known or suspected) * Intrapartum bleeding * Non-reassuring fetal tracing with following criteria: category III tracing, OR minimal variability AND decelerations of any kind, OR late decelerations occurring \>50% of contractions * 2 or more previous cesarean section, myomectomy, or classical cesarean * Need to use ripening agents prior to Foley placement * Spontaneous labor * Active genital herpes * Inability to consent * Any contraindication to a vaginal delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery Rate | Within 24 hours | The rate of women who deliver in less than or equal to 24 hours from Foley placement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obstetric Complications | Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period | — |
| Number of Participants With Time to Delivery Achieved Within 12 Hours | Within 12 hours | Number of participants with a time from Foley placement to delivery less than or equal to 12 hours |
| Total Time to Delivery | On average, 24-36 hours | — |
| Regional Analgesia | Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours | Regional analgesia used during Foley ripening |
| Number of Vaginal Deliveries | Assessed after delivery, on average occurring between 24-48 hours | — |
| Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | Assessed from birth through discharge, on average 2 days after birth | — |
| Neonatal Outcome: Neonatal Weight | Assessed from birth through discharge, on average 2 days after birth | — |
| Time to Foley Expulsion | 0-12 hours | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nulliparous - Foley Only Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter | 94 |
| Nulliparous - Foley and Oxytocin Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter | 90 |
| Multi(Primi)Parous - Foley Only Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.
Transcervical Foley catheter | 67 |
| Multi(Primi)Parous - Foley and Oxytocin Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient's thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.
Oxytocin
Transcervical Foley catheter | 71 |
| Total | 322 |
Baseline characteristics
| Characteristic | Nulliparous - Foley Only | Nulliparous - Foley and Oxytocin | Multi(Primi)Parous - Foley Only | Multi(Primi)Parous - Foley and Oxytocin | Total |
|---|---|---|---|---|---|
| Age, Continuous | 27 years STANDARD_DEVIATION 5 | 27 years STANDARD_DEVIATION 6 | 31 years STANDARD_DEVIATION 5 | 31 years STANDARD_DEVIATION 5 | 29 years STANDARD_DEVIATION 1 |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 6 Participants | 3 Participants | 3 Participants | 0 Participants | 12 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 41 Participants | 30 Participants | 39 Participants | 35 Participants | 145 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 38 Participants | 49 Participants | 16 Participants | 29 Participants | 132 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 7 Participants | 5 Participants | 8 Participants | 5 Participants | 25 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Female | 94 Participants | 90 Participants | 67 Participants | 71 Participants | 322 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 90 | 0 / 67 | 0 / 71 |
| other Total, other adverse events | 1 / 94 | 0 / 90 | 0 / 67 | 1 / 71 |
| serious Total, serious adverse events | 0 / 94 | 0 / 90 | 0 / 67 | 0 / 71 |
Outcome results
Primary
Delivery Rate
The rate of women who deliver in less than or equal to 24 hours from Foley placement.
Time frame: Within 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nulliparous - Foley Only | Delivery Rate | 40 Participants |
| Nulliparous - Foley and Oxytocin | Delivery Rate | 58 Participants |
| Multi(Primi)Parous - Foley Only | Delivery Rate | 48 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Delivery Rate | 62 Participants |
Secondary
Neonatal Outcome: Neonatal Weight
Time frame: Assessed from birth through discharge, on average 2 days after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nulliparous - Foley Only | Neonatal Outcome: Neonatal Weight | 3301 grams | Standard Deviation 524 |
| Nulliparous - Foley and Oxytocin | Neonatal Outcome: Neonatal Weight | 3278 grams | Standard Deviation 570 |
| Multi(Primi)Parous - Foley Only | Neonatal Outcome: Neonatal Weight | 3177 grams | Standard Deviation 523 |
| Multi(Primi)Parous - Foley and Oxytocin | Neonatal Outcome: Neonatal Weight | 3164 grams | Standard Deviation 579 |
Secondary
Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7
Time frame: Assessed from birth through discharge, on average 2 days after birth
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nulliparous - Foley Only | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | NICU admission | 27 Participants |
| Nulliparous - Foley Only | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | Macrosomia | 9 Participants |
| Nulliparous - Foley Only | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | 5-minute Apgar score <7 | 5 Participants |
| Nulliparous - Foley and Oxytocin | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | NICU admission | 23 Participants |
| Nulliparous - Foley and Oxytocin | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | Macrosomia | 8 Participants |
| Nulliparous - Foley and Oxytocin | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | 5-minute Apgar score <7 | 0 Participants |
| Multi(Primi)Parous - Foley Only | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | 5-minute Apgar score <7 | 2 Participants |
| Multi(Primi)Parous - Foley Only | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | NICU admission | 12 Participants |
| Multi(Primi)Parous - Foley Only | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | Macrosomia | 3 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | NICU admission | 11 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | Macrosomia | 6 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7 | 5-minute Apgar score <7 | 1 Participants |
Secondary
Number of Participants With Time to Delivery Achieved Within 12 Hours
Number of participants with a time from Foley placement to delivery less than or equal to 12 hours
Time frame: Within 12 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nulliparous - Foley Only | Number of Participants With Time to Delivery Achieved Within 12 Hours | 2 Participants |
| Nulliparous - Foley and Oxytocin | Number of Participants With Time to Delivery Achieved Within 12 Hours | 7 Participants |
| Multi(Primi)Parous - Foley Only | Number of Participants With Time to Delivery Achieved Within 12 Hours | 13 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Number of Participants With Time to Delivery Achieved Within 12 Hours | 23 Participants |
Secondary
Number of Vaginal Deliveries
Time frame: Assessed after delivery, on average occurring between 24-48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nulliparous - Foley Only | Number of Vaginal Deliveries | 59 Participants |
| Nulliparous - Foley and Oxytocin | Number of Vaginal Deliveries | 49 Participants |
| Multi(Primi)Parous - Foley Only | Number of Vaginal Deliveries | 54 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Number of Vaginal Deliveries | 59 Participants |
Secondary
Obstetric Complications
Time frame: Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nulliparous - Foley Only | Obstetric Complications | Tachysystole | 8 Participants |
| Nulliparous - Foley Only | Obstetric Complications | Chorioamnionitis | 17 Participants |
| Nulliparous - Foley Only | Obstetric Complications | Meconium | 14 Participants |
| Nulliparous - Foley Only | Obstetric Complications | Postpartum hemorrhage | 14 Participants |
| Nulliparous - Foley Only | Obstetric Complications | Uterine rupture | 0 Participants |
| Nulliparous - Foley Only | Obstetric Complications | Maternal death | 0 Participants |
| Nulliparous - Foley and Oxytocin | Obstetric Complications | Maternal death | 0 Participants |
| Nulliparous - Foley and Oxytocin | Obstetric Complications | Postpartum hemorrhage | 11 Participants |
| Nulliparous - Foley and Oxytocin | Obstetric Complications | Tachysystole | 10 Participants |
| Nulliparous - Foley and Oxytocin | Obstetric Complications | Meconium | 20 Participants |
| Nulliparous - Foley and Oxytocin | Obstetric Complications | Chorioamnionitis | 11 Participants |
| Nulliparous - Foley and Oxytocin | Obstetric Complications | Uterine rupture | 0 Participants |
| Multi(Primi)Parous - Foley Only | Obstetric Complications | Chorioamnionitis | 3 Participants |
| Multi(Primi)Parous - Foley Only | Obstetric Complications | Meconium | 8 Participants |
| Multi(Primi)Parous - Foley Only | Obstetric Complications | Postpartum hemorrhage | 8 Participants |
| Multi(Primi)Parous - Foley Only | Obstetric Complications | Maternal death | 0 Participants |
| Multi(Primi)Parous - Foley Only | Obstetric Complications | Uterine rupture | 0 Participants |
| Multi(Primi)Parous - Foley Only | Obstetric Complications | Tachysystole | 1 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Obstetric Complications | Uterine rupture | 0 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Obstetric Complications | Maternal death | 0 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Obstetric Complications | Chorioamnionitis | 2 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Obstetric Complications | Postpartum hemorrhage | 6 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Obstetric Complications | Tachysystole | 3 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Obstetric Complications | Meconium | 5 Participants |
Secondary
Regional Analgesia
Regional analgesia used during Foley ripening
Time frame: Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nulliparous - Foley Only | Regional Analgesia | 2 Participants |
| Nulliparous - Foley and Oxytocin | Regional Analgesia | 13 Participants |
| Multi(Primi)Parous - Foley Only | Regional Analgesia | 1 Participants |
| Multi(Primi)Parous - Foley and Oxytocin | Regional Analgesia | 11 Participants |
Secondary
Time to Foley Expulsion
Time frame: 0-12 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nulliparous - Foley Only | Time to Foley Expulsion | 11.8 hours |
| Nulliparous - Foley and Oxytocin | Time to Foley Expulsion | 7.2 hours |
| Multi(Primi)Parous - Foley Only | Time to Foley Expulsion | 7.9 hours |
| Multi(Primi)Parous - Foley and Oxytocin | Time to Foley Expulsion | 5.8 hours |
Secondary
Total Time to Delivery
Time frame: On average, 24-36 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nulliparous - Foley Only | Total Time to Delivery | 26.1 hours |
| Nulliparous - Foley and Oxytocin | Total Time to Delivery | 20.9 hours |
| Multi(Primi)Parous - Foley Only | Total Time to Delivery | 18.6 hours |
| Multi(Primi)Parous - Foley and Oxytocin | Total Time to Delivery | 14.9 hours |