Induction of Labor Affected Fetus / Newborn
Conditions
Brief summary
This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. This project will include 157 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 either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy Women will be randomized with equal probability to the intervention group using block randomization stratified by party. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
Interventions
PROCEDUREamniotomy
Artificially rupturing membranes
DEVICEFoley Catheter
Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline.
DRUGMisoprostol
Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg.
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
No
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 * Bishop score of ≤6 and cervical dilation ≤2cm
Exclusion criteria
* Any contraindication to a vaginal delivery or to misoprostol * fetal demise * Multifetal gestation * major fetal anomaly * prior uterine surgery, previous cesarean section * women with HIV, hepatitis C, hepatitis B, and women with medical conditions requiring an assisted second stage * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to delivery | Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours. | time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to vaginal delivery | At time of delivery | time to delivery (hours) defined as time from Foley Catheter expulsion to delivery |
| Maternal length of stay | through study completion, an average of 4 days | time from admission to discharge |
| Indication for cesarean delivery | At time of delivery | discrete |
| Chorioamnionitis | At time of delivery | defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness |
| Cesarean delivery rate | At time of delivery | binary; yes/no |
| Blood transfusion | through study completion, an average of 1 year | binary; yes/no |
| Endometritis | From time of delivery to time of hospital discharge; up to 6 weeks | binary; yes/no |
| Wound separation-infection | through study completion, an average of 1 year | binary, yes/no; defined by the need for additional wound closure or the need for antibiotics |
| Neonatal death | through study completion, an average of 1 year | binary, yes/no |
| 3rd/4th degree perineal laceration | at time of delivery | binary; yes/no |
Countries
United States
Outcome results
None listed