Fetal Pillow Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Outcomes Following Cesarean Delivery for Failure to Progress With Use of a Fetal Pillow

Conditions
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Labor Complication

Intervention / Treatment
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* Device: Fetal Pillow


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fetal Pillow Inflated (FPI)<br>A Fetal Pillow will be 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. The obstetrician will not be aware to inflation of Fetal Pillow Cesarean delivery will then be performed The circulating nurse will deflate the Fetal Pillow following delivery. The obstetrician will remove the Fetal Pillow at the end of the procedure. The obstetrician will then fill out a survey regarding the delivery. | Device: Fetal Pillow<br>* see arm description<br>|
| No Intervention: Fetal Pillow Not Inflated (FPNI)<br>A Fetal Pillow will be 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 Fetal Pillow will not be inflated. Cesarean delivery will then be performed. 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 circulating nurse will deflate the Fetal Pillow following delivery. The obstetrician will remove the Fetal Pillow at the end of the procedure. The obstetrician will then fill out a survey regarding the delivery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine incision to delivery time | Time (in seconds) from hysterotomy to delivery | Assessed at time of delivery, delivery day (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulty of Delivery of Fetal head | Score of difficulty of delivery 1-5 (1: very difficult, 5: very easy) | Assessed at time of delivery, delivery day (day 0) | 
| Uterine extension | Grading of extension 1-3 | Assessed at time of delivery, delivery day (day 0) | 
| Composite Maternal Morbidity | 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 | Assessed both following delivery (day 0) and at end of study period (week 4) | 
| Length of stay | Maternal Length of stay | Assessed at end of study period (week 4) | 
| Fetal Weight | Weight of fetus at time of birth | Assessed at time of delivery, delivery day (day 0) | 
| 1 minute APGAR | Assessment of the 1 minute APGAR | Assessed at time of delivery, delivery day (day 0) | 
| 5 minute APGAR | Assessment of the 5 minute APGAR | Assessed at time of delivery, delivery day (day 0) | 
| Composite Neonatal Morbidity | Need for intubation, fetal trauma | Assessed at end of study period (week 4) | 
| Neonatal Intensive Care Unit (NICU) Length of Stay | Length of stay in NICU | Assessed at end of study period (week 4) | 
| Provider Opinions | Willingness to recommend to others based on ease of placement and removal (1-5 point scale) | Assessed at end of study period (week 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal outcomes, Neonatal Outcomes