Labor; Forced or Induced, Affecting Fetus or Newborn
Conditions
Keywords
unripe cervix
Brief summary
The goal of this study is to determine whether inducing labor with just one dose of misoprostol, followed by treatment with oxytocin, will still be effective enough to increase the chances of having a successful vaginal delivery as compared to using more than one dose of misoprostol, followed by treatment with oxytocin.
Detailed description
This study involves a comparison of two different regimens of prostaglandin use for cervical ripening prior to induction of labor. Women admitted to the hospital for induction of labor who are found to have unripe cervixes at the time of admission, and who agree to participate in the study will be randomly assigned to one of two treatment groups. In one group, a single dose of 25 µcg of misoprostol will be administered vaginally and four hours later oxytocin induction will be started if clinically indicated. In the second group of women, repeat doses of misoprostol will be given every four hours up to six doses unless labor or cervical ripening occurs sooner. At this point, oxytocin will be started as needed. Success of vaginal delivery by 24 hours, time from initiation of protocol to delivery and cesarean section rates will be compared. Complications such as postpartum hemorrhage, episodes of tachysystole with fetal compromise and chorioamnionitis and endometritis will be monitored.
Interventions
DRUGMisoprostol
Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Any pregnant woman undergoing induction of labor * Live singleton pregnancy ≥ 37 week gestation * Bishop score \< 6 * Category I fetal heart rate
Exclusion criteria
* Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex presentation, umbilical cord prolapse, and active genital herpes infection.) * Pregnancies complicated by major fetal anomalies * Any contraindication to the use of misoprostol, including * History of previous c-section or major uterine surgery * Prior allergic reaction * Category II or III fetal heart rate * Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30 minutes * Estimated fetal weight \< 10 percentile * Premature rupture of membranes * Age \< 18 years old * Women who do not have the capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vaginal Delivery Within 24 Hours | within 24 hours | To compare the rate of vaginal delivery within 24 hours in patients who receive a single dose of misoprostol versus those receiving multiple doses of this medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group | within 24 hours from the initial intervention | To determine the interval from initiation of misoprostol to delivery in each group |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Dose single dose of misoprostol
Misoprostol: Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix. | 120 |
| Multiple Dose multiple doses of misoprostol
Misoprostol: Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix. | 123 |
| Total | 243 |
Baseline characteristics
| Characteristic | Single Dose | Multiple Dose | 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 | 120 Participants | 123 Participants | 243 Participants |
| Race/Ethnicity, Customized Black/African | 38 Participants | 44 Participants | 82 Participants |
| Race/Ethnicity, Customized Hispanic | 57 Participants | 53 Participants | 110 Participants |
| Race/Ethnicity, Customized other | 25 Participants | 26 Participants | 51 Participants |
| Region of Enrollment United States | 120 participants | 123 participants | 243 participants |
| Sex: Female, Male Female | 120 Participants | 123 Participants | 243 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 / 120 | 0 / 123 |
| other Total, other adverse events | 0 / 120 | 0 / 123 |
| serious Total, serious adverse events | 0 / 120 | 0 / 123 |
Outcome results
Primary
Number of Participants With Vaginal Delivery Within 24 Hours
To compare the rate of vaginal delivery within 24 hours in patients who receive a single dose of misoprostol versus those receiving multiple doses of this medication.
Time frame: within 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Dose | Number of Participants With Vaginal Delivery Within 24 Hours | 50 Participants |
| Multiple Dose | Number of Participants With Vaginal Delivery Within 24 Hours | 55 Participants |
Secondary
To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group
To determine the interval from initiation of misoprostol to delivery in each group
Time frame: within 24 hours from the initial intervention
Population: Minutes from initiation of misoprostol to delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Dose | To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group | 1187 Median number of Minutes |
| Multiple Dose | To Determine the Interval From Initiation of Misoprostol to Delivery in Each Group | 1321 Median number of Minutes |
p-value: 0.202Wilcoxon (Mann-Whitney)