Induction of Labor
Conditions
Brief summary
Combined misoprostol and Foley bulb catheter has been shown to be an effective induction method. However, optimal route of administration for misoprostol has not been established. Therefore, the purpose of this study is to compare the effectiveness and safety of combination buccal miso-foley to combination vaginal miso-foley for third trimester cervical ripening and induction of labor.
Detailed description
This randomized controlled trial of consenting women undergoing induction of labor with combined misoprostol and Foley catheter seeks to efficacy of vaginal versus buccal misoprostol route of administration. This project will include 216 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with misoprostol. Following admission, women will be randomized into either vaginal or buccal misoprostol. Women will be randomized with equal probability to the intervention group using block randomization stratified by party. Patients will receive 25 micrograms of misoprostol along with the insertion of a16F Foley catheter. Misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. The remainder of labor management will be at the discretion of each woman's obstetric provider. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
Interventions
DRUGMisoprostol
Women randomized to either vaginal or buccal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of vaginal or buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water. vaginal or Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated.
Sponsors
Christiana Care Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* ≥18 years of age * full term (≥37 weeks) gestations determined by routine obstetrical guidelines * singleton gestation in cephalic presentation * Both nulliparous and multiparous women * Intact membranes * Cervical dilation ≤2cm
Exclusion criteria
* Any contraindication to a vaginal delivery or to misoprostol * fetal demise * Multifetal gestation * prior uterine surgery, previous cesarean section * Tachysystole was defined as at least 6 contractions in 10 minutes for 2 consecutive 10-minute periods * women with HIV, and women with medical conditions requiring an assisted second stage * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to delivery (hours) defined | through study completion, an average of 2 year | as time from initiation of induction method to delivery time, regardless of mode of delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Analgesia use | through study completion, an average of 2 year | yes/no |
| Rate of Endometritis | through study completion, an average of 2 year | yes/no; fundal tenderness and fever that required treatment with antibiotics |
| Rate of Wound separation-infection | From time of delivery to time of hospital discharge; up to 6 weeks | the need for additional wound closure or the need for antibiotics |
| Rate of Venous thromboembolism | through study completion, an average of 2 year | yes/no |
| Rate of Hysterectomy | through study completion, an average of 2 year | yes/no |
| Rate of Intensive care unit admission | through study completion, an average of 2 year | yes/no |
| Rate of Maternal Death | through study completion, an average of 2 year | yes/no |
| Rate of Chorioamnionitis | through study completion, an average of 2 year | the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness |
| Rate of terbutaline use | through study completion, an average of 2 year | yes/no |
| Rate of Intrauterine pressure catheter use | through study completion, an average of 2 year | yes/no |
| Rate of Cesarean delivery | through study completion, an average of 2 year | yes/no |
| Time to active labor | through study completion, an average of 2 year | s time from initiation of induction method to dilatation ≥6cm |
| Rate of Amnioinfusion | through study completion, an average of 2 year | yes/no |
| Indication for cesarean delivery | through study completion, an average of 2 year | The reason for induction: NRFHT, arrest of dilation, arrest of descent, failed IOL, other |
| Rate of 3rd/4th degree perineal laceration | through study completion, an average of 2 year | yes/no |
| Rate of Maternal Blood transfusion | through study completion, an average of 2 year | yes/no |
| Rate of Severe respiratory distress syndrome | From time of delivery to hospital discharge; up to 6 weeks | defined as intubation and mechanical ventilation for a minimum of 12 hours |
| Rate of Culture proven-presumed neonatal sepsis | From time of delivery to hospital discharge; up to 6 weeks | yes/no |
| Rate of Neonatal blood transfusion | From time of delivery to hospital discharge; up to 6 weeks | yes/no |
| Rate of Hypoxic ischemic encephalopathy | From time of delivery to hospital discharge; up to 6 weeks | yes/no |
| Rate of Intraventricular hemorrhage grade 3 or 4 | From time of delivery to hospital discharge; up to 6 weeks | yes/no |
| Rate of Necrotizing enterocolitis | From time of delivery to hospital discharge; up to 6 weeks | yes/no |
| Rate of head cooling. | From time of delivery to hospital discharge; up to 6 weeks | yes/no |
| Rate of NICU admission | From time of delivery to hospital discharge; up to 6 weeks | yes/no |
| Maternal length of stay | through study completion, an average of 2 year | defined as length of time from admission for induction to discharge postpartum, days |
Countries
United States
Outcome results
None listed