Labor Complication
Conditions
Keywords
Maternal outcomes, Neonatal Outcomes
Brief summary
The purpose of this study is to evaluate outcomes following cesarean delivery for failure to progress with the use of the Fetal Pillow. Our hypothesis is that time to delivery of the fetus is shorter with implementation of the Fetal Pillow.
Detailed description
Women will be enrolled from the labor floor during their labor course when there is concern for cesarean section for failure to progress in the second stage of labor. These women may be approached if they have a prolonged labor course (before they reach full dilation), when they get to full dilation and start pushing, or following an unsuccessful operative delivery. All women who meet the inclusion criteria will be approached about participation in the study on labor and delivery. The process of informed consent will happen at that time on labor and delivery. All women will be enrolled by study staff or certain physicians at Brigham and Women's Hospital who have agreed to help consent patients for this study. Once consent is obtained, the subjects will then be randomized 1:1 into two parallel groups, the Fetal Pillow Inflated (FPI) group and the Fetal Pillow Not Inflated (FPNI) group. A random number generator will allocate the groups in blocks of ten. The Fetal Pillows used in the study have been donated by Safe Obstetrics Systems. Each patient will have a Fetal Pillow inserted vaginally by the obstetrician after catheterization of the bladder (if it has not been previously performed). Once the Fetal Pillow is in place, the woman's legs will be placed flat on the operating table. The anesthesiologist will then inflate the Fetal Pillow if the patient has been randomized into the Fetal Pillow Inflated (FPI) group. In the Fetal Pillow Not Inflated (FPNI) group, the device will remain, not inflated, in the vagina. The obstetrician will therefore be blinded to the intervention. In the FPNI group the obstetrician will continue to be able to use conventional methods for delivery of a second stage arrest including hand from below and reverse breech extraction. The Fetal Pillow will be drained by the circulating nurse in the operating room following delivery with removal at the end of the procedure by the obstetrician.
Interventions
DEVICEFetal Pillow
see arm description
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Each patient will have a Fetal Pillow inserted vaginally by the obstetrician after catheterization of the bladder (if it has not been previously performed). Once the Fetal Pillow is in place, the woman's legs will be placed flat on the operating table. The anesthesiologist will then inflate the Fetal Pillow if the patient has been randomized into the Fetal Pillow Inflated (FPI) group. In the Fetal Pillow Not Inflated (FPNI) group, the device will remain, not inflated, in the vagina. The obstetrician will therefore be blinded to the intervention.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* women age 18-50 * term pregnancy (37- 41 6/7 weeks) * singleton gestation in cephalic presentation * fully dilated * both nulliparous and multiparous women * both spontaneous labor and labor inductions
Exclusion criteria
* breech presentation * presence of contraindication to vaginal delivery * prior cesarean section * presence of congenital anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uterine incision to delivery time | Assessed at time of delivery, delivery day (day 0) | Time (in seconds) from hysterotomy to delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine extension | Assessed at time of delivery, delivery day (day 0) | Grading of extension 1-3 |
| Composite Maternal Morbidity | Assessed both following delivery (day 0) and at end of study period (week 4) | Blood loss, presence of blood transfusion, change in hematocrit from preop to postop day 1, temperature\>100.4, ICU transfer, presence of Disseminated intravascular coagulation (DIC), readmission |
| Length of stay | Assessed at end of study period (week 4) | Maternal Length of stay |
| Fetal Weight | Assessed at time of delivery, delivery day (day 0) | Weight of fetus at time of birth |
| Difficulty of Delivery of Fetal head | Assessed at time of delivery, delivery day (day 0) | Score of difficulty of delivery 1-5 (1: very difficult, 5: very easy) |
| 5 minute APGAR | Assessed at time of delivery, delivery day (day 0) | Assessment of the 5 minute APGAR |
| Composite Neonatal Morbidity | Assessed at end of study period (week 4) | Need for intubation, fetal trauma |
| Neonatal Intensive Care Unit (NICU) Length of Stay | Assessed at end of study period (week 4) | Length of stay in NICU |
| Provider Opinions | Assessed at end of study period (week 4) | Willingness to recommend to others based on ease of placement and removal (1-5 point scale) |
| 1 minute APGAR | Assessed at time of delivery, delivery day (day 0) | Assessment of the 1 minute APGAR |
Countries
United States
Outcome results
None listed