Induced Vaginal Delivery
Conditions
Keywords
Induced Vaginal Delivery, Cervical Ripening, Mechanical Cervical Ripening
Brief summary
Foley balloons are commonly used as a mechanical method of cervical ripening for induction of labor. Foley balloons may be placed either under tension or without tension (tension-free). The purpose of our study is to examine time to delivery in nulliparous women undergoing induction of labor who have a Foley balloon placed as a mechanical cervical dilator, assigned to either tension or without tension. The goal is to determine if there is a potential added benefit to placing the Foley balloon on tension as compared to no tension. Our hypothesis is that Foley balloon under tension for cervical ripening results in shorter time to vaginal delivery compared to Foley balloon placed without tension.
Detailed description
This is a pragmatic cluster randomized clinical trial. The target population is nulliparous women who present for induction of labor at term. If there is a decision by the obstetric team to place a transcervical Foley dilator for cervical ripening in a prospective subject meeting inclusion criteria for the study, the obstetric provider will follow the weekly randomization sequence for study group (No Tension) or the control group (Tension) based on the assigned cluster for the entire unit for that week. Both study groups will receive standardized labor management as Foley balloon placed with tension and without tension are both considered standard of care at our institution. The Tension standard of care (control group) will undergo induction of labor by placement of a transcervical Foley balloon, which is standard of care at our institution. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh. The No Tension standard of care (study group) will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely. Subjects in the control and study group will then undergo standard intrapartum care. The total participation time in the study will be considered terminated following delivery.
Interventions
OTHERPlacement of Foley balloon for cervical ripening with tension.
A Foley balloon will be placed for cervical ripening with tension.
OTHERPlacement of Foley balloon for cervical ripening without tension.
A Foley balloon will be placed for cervical ripening without tension.
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Term induction of labor * Nulliparous * Vertex * Singleton * Plan for Foley balloon placement by the managing obstetrics team * Cervical exam less than 3 cm dilated and less than or equal to 60% effaced
Exclusion criteria
* Patient unwilling or unable to provide verbal consent * Fetal demise or major congenital anomaly * Preterm (\<37 0/7weeks) * Multiple gestation * Previous uterine surgery * Abnormal placentation * Malpresentation * Magnesium infusion for preeclampsia with severe features * Prelabor rupture of membranes * Fetal growth restriction * Non-reassuring fetal heart rate tracing prior to inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Vaginal Delivery | Foley bulb placement to vaginal delivery, up to 24 Hours | Time to vaginal delivery measured from time of initial Foley balloon placement to delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Requested Analgesia Following Placement of the Foley Balloon | Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours) | Request for IV pain medications or epidural following placement of Foley balloon |
| Number of Participants That Had a Primary Cesarean Delivery | Placement of Foley balloon until cesarean delivery, up to 24 Hours | Number of participants that had a primary cesarean delivery |
| Number of Participants With Chorioamnionitis | Placement of Foley balloon until delivery, up to 24 Hours | Number of participants with chorioamnionitis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postpartum Hemorrhage | Placement of Foley balloon until 24 hours postpartum | Number of participants with postpartum hemorrhage |
Countries
United States
Participant flow
Pre-assignment details
The intervention is assigned at the cluster (weekly) level; the total number of participants enrolled will be reported as a single total and not separated by clusters.
Participants by arm
| Arm | Count |
|---|---|
| Without Tension (Tension Free) The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Placement of Foley balloon for cervical ripening without tension.: A Foley balloon will be placed for cervical ripening without tension. | 141 |
| Tension The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
Placement of Foley balloon for cervical ripening with tension.: A Foley balloon will be placed for cervical ripening with tension. | 138 |
| Total | 279 |
Baseline characteristics
| Characteristic | Without Tension (Tension Free) | Total | Tension |
|---|---|---|---|
| Age, Continuous | 23 years | 22 years | 22 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 94 Participants | 182 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 97 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 34 Participants | 14 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 | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 115 Participants | 237 Participants | 122 Participants |
| Region of Enrollment United States | 141 Participants | 279 Participants | 138 Participants |
| Sex: Female, Male Female | 141 Participants | 279 Participants | 138 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 | 0 / 141 | 0 / 138 |
| other Total, other adverse events | 0 / 141 | 0 / 138 |
| serious Total, serious adverse events | 0 / 141 | 0 / 138 |
Outcome results
Primary
Time to Vaginal Delivery
Time to vaginal delivery measured from time of initial Foley balloon placement to delivery
Time frame: Foley bulb placement to vaginal delivery, up to 24 Hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Without Tension (Tension Free) | Time to Vaginal Delivery | 1608 minutes |
| Tension | Time to Vaginal Delivery | 1595.5 minutes |
Secondary
Number of Participants That Had a Primary Cesarean Delivery
Number of participants that had a primary cesarean delivery
Time frame: Placement of Foley balloon until cesarean delivery, up to 24 Hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Without Tension (Tension Free) | Number of Participants That Had a Primary Cesarean Delivery | 42 Participants |
| Tension | Number of Participants That Had a Primary Cesarean Delivery | 47 Participants |
Secondary
Number of Participants That Requested Analgesia Following Placement of the Foley Balloon
Request for IV pain medications or epidural following placement of Foley balloon
Time frame: Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Without Tension (Tension Free) | Number of Participants That Requested Analgesia Following Placement of the Foley Balloon | 119 Participants |
| Tension | Number of Participants That Requested Analgesia Following Placement of the Foley Balloon | 114 Participants |
Secondary
Number of Participants With Chorioamnionitis
Number of participants with chorioamnionitis
Time frame: Placement of Foley balloon until delivery, up to 24 Hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Without Tension (Tension Free) | Number of Participants With Chorioamnionitis | 40 Participants |
| Tension | Number of Participants With Chorioamnionitis | 48 Participants |
Other Pre-specified
Number of Participants With Postpartum Hemorrhage
Number of participants with postpartum hemorrhage
Time frame: Placement of Foley balloon until 24 hours postpartum
Population: Outcome measure not assessed