Fetal Pillow Randomized Controlled Trial
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 4/17/2018 |
| Start Date: | January 13, 2018 |
| End Date: | December 1, 2020 |
| Contact: | Sarah C Lassey, MD |
| Email: | slassey@partners.org |
| Phone: | 4014741167 |
Outcomes Following Cesarean Delivery for Failure to Progress With Use of a Fetal Pillow
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.
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.
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.
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.
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
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Phone: 401-474-1167
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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