Fetal Pillow Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-13

Study Completion Date

2019-08-01

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.

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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.

Conditions

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Labor Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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Fetal Pillow Inflated (FPI)

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.

Group Type EXPERIMENTAL

Fetal Pillow

Intervention Type DEVICE

see arm description

Fetal Pillow Not Inflated (FPNI)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fetal Pillow

see arm description

Intervention Type DEVICE

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