Induction of Labor
Conditions
Keywords
Cervical Ripening, Rate of Cesearean Section
Brief summary
The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.
Detailed description
The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.
Interventions
DRUGOxytocin
Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
DRUGMisoprostol
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Sponsors
Aultman Health Foundation
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
* Participant or surrogate is capable of giving informed consent * Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy * Participant is undergoing an indicated induction of labor * Participant is found to have cervical Bishop score ≤5 on initial cervical exam * Participant has no medical or obstetrical contraindications to induction of labor
Exclusion criteria
* Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods * Manufacturer's contraindications to misoprostol or oxytocin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Induction To Delivery | 24 hrs | To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delivery Route | 24 hrs | To assess for differences in delivery routes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute. | 25 |
| Misoprostol Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Oxytocin | Misoprostol | Total |
|---|---|---|---|
| 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 | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 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 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Rate of Induction To Delivery
To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times
Time frame: 24 hrs
Population: Patients requiring caesarean section excluded from analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Rate of Induction To Delivery | 732.19 minutes | Standard Deviation 236.99 |
| Misoprostol | Rate of Induction To Delivery | 944.35 minutes | Standard Deviation 317.78 |
p-value: 0.03795% CI: [13.3, 411]t-test, 2 sided
Secondary
Delivery Route
To assess for differences in delivery routes
Time frame: 24 hrs
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxytocin | Delivery Route | Vagnial Delivery | 16 Participants |
| Oxytocin | Delivery Route | Cesearean | 9 Participants |
| Misoprostol | Delivery Route | Vagnial Delivery | 17 Participants |
| Misoprostol | Delivery Route | Cesearean | 8 Participants |