Induction of Labor
Conditions
Keywords
labor induction, foley bulb, misoprostol
Brief summary
The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.
Detailed description
More than 22% of all gravid women undergo induction of labor in the United States for various indications. Although there are several techniques and methods for induction of labor, the best agent and method still remains uncertain. To date, there has been no randomized trial comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an additive or synergistic effect, resulting in greater degree of cervical ripening and shorter induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb without effacement.
Interventions
DEVICEFoley bulb
This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* singleton pregnancy * vertex presentation * unfavorable cervix(Bishop's score less than or equal to 6) * greater than 24 weeks gestation
Exclusion criteria
* fetal malpresentation * multifetal gestation * spontaneous labor * more than 5 uterine contractions in 10 minutes * contraindication to prostaglandins * non-reassuring fetal heart rate tracing * intrauterine growth restriction * anomalous fetus * fetal demise * previous cesarean delivery or other significant uterine surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time From Start of Labor Induction to Vaginal Delivery | 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NICU Admission | 96 hours | — |
| Successful Number of Vaginal and Cesarean Deliveries | 72 hours | To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries. |
| Number of Participants Experiencing Tachysystole With Deceleration | 72 hours | — |
| Number of Participants With Post-partum Hemorrhage | 96 hours | — |
| Chorioamnionitis | 96 hours | — |
| Neonatal APGAR Scores | 5 minutes | APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score: Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort) |
| Time to Complete Cervical Dilation | 72 hours | We will record the start time of induction until the patient's cervix is 10cm dilated |
| Delivery Within 24 Hours | Delivery within 24 hours of induction | — |
| Admission to NICU or Special Care Nursery | birth to 96 hours of age | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Foley Bulb Plus Misoprostol In the combination arm participants received vaginal misoprostol at 25 micrograms every 4 hours. The foley bulb was also inserted in these participants. | 56 |
| Misoprostol The participants in this arm received misoprostol 25 micrograms every 4 hours. | 61 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive treatment | 2 | 6 |
Baseline characteristics
| Characteristic | Foley Bulb Plus Misoprostol | Total | Misoprostol |
|---|---|---|---|
| Age, Continuous | 25.7 years STANDARD_DEVIATION 7.2 | NA years | 24.2 years STANDARD_DEVIATION 5.5 |
| Indication for labor inductions Chronic Hypertension | 4 Participants | 8 Participants | 4 Participants |
| Indication for labor inductions Elective | 6 Participants | 14 Participants | 8 Participants |
| Indication for labor inductions Gestational diabetes | 3 Participants | 5 Participants | 2 Participants |
| Indication for labor inductions Oligohydramnios | 2 Participants | 3 Participants | 1 Participants |
| Indication for labor inductions Other | 6 Participants | 12 Participants | 6 Participants |
| Indication for labor inductions Postdates | 24 Participants | 50 Participants | 26 Participants |
| Indication for labor inductions Preeclampsia | 7 Participants | 15 Participants | 8 Participants |
| Indication for labor inductions Pregestational diabetes | 2 Participants | 6 Participants | 4 Participants |
| Indication for labor inductions Pregnancy induced hyptertension | 2 Participants | 4 Participants | 2 Participants |
| Maternal weight | 89.6 kg STANDARD_DEVIATION 20.3 | NA kg | 90.6 kg STANDARD_DEVIATION 24.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 74 Participants | 40 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 | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) White | 13 Participants | 24 Participants | 11 Participants |
| Region of Enrollment United States | 56 participants | 117 participants | 61 participants |
| Sex: Female, Male Female | 56 Participants | 117 Participants | 61 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 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time From Start of Labor Induction to Vaginal Delivery
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foley Bulb Plus Misoprostol | Time From Start of Labor Induction to Vaginal Delivery | 15.3 hour | Standard Deviation 6.5 |
| Misoprostol | Time From Start of Labor Induction to Vaginal Delivery | 18.3 hour | Standard Deviation 8.7 |
p-value: 0.0395% CI: [-5.9, -0.3]t-test, 2 sided
Secondary
Admission to NICU or Special Care Nursery
Time frame: birth to 96 hours of age
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Plus Misoprostol | Admission to NICU or Special Care Nursery | 8 Participants |
| Misoprostol | Admission to NICU or Special Care Nursery | 11 Participants |
Secondary
Chorioamnionitis
Time frame: 96 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Plus Misoprostol | Chorioamnionitis | 5 Participants |
| Misoprostol | Chorioamnionitis | 7 Participants |
Secondary
Delivery Within 24 Hours
Time frame: Delivery within 24 hours of induction
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Plus Misoprostol | Delivery Within 24 Hours | 49 Participants |
| Misoprostol | Delivery Within 24 Hours | 46 Participants |
Secondary
Neonatal APGAR Scores
APGAR scores will be recorded at 1 and 5 minutes after birth. In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score: Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)
Time frame: 5 minutes
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Foley Bulb Plus Misoprostol | Neonatal APGAR Scores | 1 minute apgar scord | 8 score on a scale |
| Foley Bulb Plus Misoprostol | Neonatal APGAR Scores | 5 minute apgar score | 9 score on a scale |
| Misoprostol | Neonatal APGAR Scores | 1 minute apgar scord | 8 score on a scale |
| Misoprostol | Neonatal APGAR Scores | 5 minute apgar score | 9 score on a scale |
Secondary
NICU Admission
Time frame: 96 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Plus Misoprostol | NICU Admission | 0 Participants |
| Misoprostol | NICU Admission | 2 Participants |
Secondary
Number of Participants Experiencing Tachysystole With Deceleration
Time frame: 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Plus Misoprostol | Number of Participants Experiencing Tachysystole With Deceleration | 10 Participants |
| Misoprostol | Number of Participants Experiencing Tachysystole With Deceleration | 12 Participants |
Secondary
Number of Participants With Post-partum Hemorrhage
Time frame: 96 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Foley Bulb Plus Misoprostol | Number of Participants With Post-partum Hemorrhage | 2 Participants |
| Misoprostol | Number of Participants With Post-partum Hemorrhage | 5 Participants |
Secondary
Successful Number of Vaginal and Cesarean Deliveries
To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.
Time frame: 72 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foley Bulb Plus Misoprostol | Successful Number of Vaginal and Cesarean Deliveries | Vaginal delivery | 41 Participants |
| Foley Bulb Plus Misoprostol | Successful Number of Vaginal and Cesarean Deliveries | Cesarean delivery | 15 Participants |
| Misoprostol | Successful Number of Vaginal and Cesarean Deliveries | Vaginal delivery | 45 Participants |
| Misoprostol | Successful Number of Vaginal and Cesarean Deliveries | Cesarean delivery | 16 Participants |
Comparison: Comparison of vaginal delivery between groups.p-value: 0.9695% CI: [0.8, 1.23]Chi-squared
Comparison: Cesarean deliveries were compared between the groups.p-value: 0.995% CI: [0.57, 1.9]Chi-squared
Secondary
Time to Complete Cervical Dilation
We will record the start time of induction until the patient's cervix is 10cm dilated
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Foley Bulb Plus Misoprostol | Time to Complete Cervical Dilation | 13.7 hour | Standard Deviation 5.9 |
| Misoprostol | Time to Complete Cervical Dilation | 17.1 hour | Standard Deviation 8.7 |