Induction of Labor in Multiparous Women
Conditions
Brief summary
This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous oxytocin (Pitocin) in multiparous women who present at term for labor induction.
Detailed description
Both oxytocin and misoprostol have been demonstrated to be safe and effective methods for induction of labor. A direct comparison of efficacy and time to delivery in multiparas has not been specifically investigated. Additionally, the study will look at costs of the two drugs.Oxytocin is administered through an IV so requires more direct patient care time from the Registered Nurse, IV pump, and tubing, whereas misoprostol is a tablet, administered only once, per vagina or orally, every 4 hours. Misoprostol is also very inexpensive comparatively; if equally or more efficacious than oxytocin, this could demonstrate quite a cost and time savings to Vanderbilt University Medical Center and other institutions. Safety of either drug is not in question.
Interventions
DRUGVaginal Misoprostol
Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous
Sponsors
Vanderbilt University Medical Center
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
* Clinical candidate for labor induction utilizing either misoprostol or oxytocin * Greater than or equal to 18 years of age * Multiparous * Singleton gestation; * Greater than 37 weeks gestation; * Cephalic presentation
Exclusion criteria
* Any clinical contraindication to misoprostol as induction drug * Age less than 18 years * Contraindication to vaginal birth * Nonreassuring fetal heart rate tracing * Prior uterine surgery * Active labor * Active maternal bleeding * Chorioamnionitis (infection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Induction to Vaginal Delivery | Time to delivery in minutes from initiation of medication, up to 24 hours | Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Satisfaction With Labor | 6 weeks post-partum | — |
| Neonatal APGAR Scores | At 1 minute and 5 minutes after delivery | APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. |
| Maternal Delivery Outcomes | Through discharge from hospital | Maternal delivery outcomes |
| Number of Participants With Excessive Uterine Activity Necessitating Treatment | Measured from initiation of medication until delivery time | Number of patients receiving terbutaline during labor for uterine tachysytole |
| NICU Admission and APGAR Less Than 7 at 5 Minutes | Through discharge from hospital | NICU admission and APGAR less than 7 at 5 minutes |
| Neonatal Weight at Delivery | Immediately following delivery | Neonatal Weight |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaginal Misoprostol Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
Vaginal Misoprostol: Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal | 62 |
| Intravenous Oxytocin 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous
Intravenous Oxytocin: Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
Route of administration: intravenous | 59 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cesarean delivery | 2 | 7 |
Baseline characteristics
| Characteristic | Vaginal Misoprostol | Intravenous Oxytocin | 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 | 62 Participants | 59 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 55 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 10 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 6 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 46 Participants | 89 Participants |
| Region of Enrollment United States | 62 Participants | 59 Participants | 121 Participants |
| Sex: Female, Male Female | 62 Participants | 59 Participants | 121 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 / 62 | 0 / 59 |
| other Total, other adverse events | 0 / 62 | 0 / 59 |
| serious Total, serious adverse events | 0 / 62 | 0 / 59 |
Outcome results
Primary
Time From Induction to Vaginal Delivery
Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.
Time frame: Time to delivery in minutes from initiation of medication, up to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vaginal Misoprostol | Time From Induction to Vaginal Delivery | 800 minutes |
| Intravenous Oxytocin | Time From Induction to Vaginal Delivery | 693 minutes |
p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary
Maternal Delivery Outcomes
Maternal delivery outcomes
Time frame: Through discharge from hospital
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal Misoprostol | Maternal Delivery Outcomes | Hemorrhage | 2 Participants |
| Vaginal Misoprostol | Maternal Delivery Outcomes | Cesarean delivery | 2 Participants |
| Vaginal Misoprostol | Maternal Delivery Outcomes | Chorioamnionitis | 2 Participants |
| Vaginal Misoprostol | Maternal Delivery Outcomes | Forceps delivery | 4 Participants |
| Vaginal Misoprostol | Maternal Delivery Outcomes | Epidural | 56 Participants |
| Intravenous Oxytocin | Maternal Delivery Outcomes | Forceps delivery | 4 Participants |
| Intravenous Oxytocin | Maternal Delivery Outcomes | Epidural | 48 Participants |
| Intravenous Oxytocin | Maternal Delivery Outcomes | Hemorrhage | 3 Participants |
| Intravenous Oxytocin | Maternal Delivery Outcomes | Chorioamnionitis | 0 Participants |
| Intravenous Oxytocin | Maternal Delivery Outcomes | Cesarean delivery | 7 Participants |
Secondary
Maternal Satisfaction With Labor
Time frame: 6 weeks post-partum
Population: data was not collected
Secondary
Neonatal APGAR Scores
APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low.
Time frame: At 1 minute and 5 minutes after delivery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vaginal Misoprostol | Neonatal APGAR Scores | APGAR 1 minute | 8 number |
| Vaginal Misoprostol | Neonatal APGAR Scores | APGAR 5 minute | 9 number |
| Intravenous Oxytocin | Neonatal APGAR Scores | APGAR 1 minute | 8 number |
| Intravenous Oxytocin | Neonatal APGAR Scores | APGAR 5 minute | 9 number |
Secondary
Neonatal Weight at Delivery
Neonatal Weight
Time frame: Immediately following delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vaginal Misoprostol | Neonatal Weight at Delivery | 3500 grams |
| Intravenous Oxytocin | Neonatal Weight at Delivery | 3415 grams |
Secondary
NICU Admission and APGAR Less Than 7 at 5 Minutes
NICU admission and APGAR less than 7 at 5 minutes
Time frame: Through discharge from hospital
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaginal Misoprostol | NICU Admission and APGAR Less Than 7 at 5 Minutes | NICU Admission | 8 Participants |
| Vaginal Misoprostol | NICU Admission and APGAR Less Than 7 at 5 Minutes | APGAR less than 7 at 5 min | 0 Participants |
| Intravenous Oxytocin | NICU Admission and APGAR Less Than 7 at 5 Minutes | NICU Admission | 4 Participants |
| Intravenous Oxytocin | NICU Admission and APGAR Less Than 7 at 5 Minutes | APGAR less than 7 at 5 min | 0 Participants |
Secondary
Number of Participants With Excessive Uterine Activity Necessitating Treatment
Number of patients receiving terbutaline during labor for uterine tachysytole
Time frame: Measured from initiation of medication until delivery time
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vaginal Misoprostol | Number of Participants With Excessive Uterine Activity Necessitating Treatment | 9 Participants |
| Intravenous Oxytocin | Number of Participants With Excessive Uterine Activity Necessitating Treatment | 4 Participants |