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Fetal Pillow Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342508
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Julian N Robinson, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Labor Complication Device: Fetal Pillow Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Prevention
Official Title: Outcomes Following Cesarean Delivery for Failure to Progress With Use of a Fetal Pillow
Actual Study Start Date : January 13, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Arm Intervention/treatment
Experimental: 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.

Device: Fetal Pillow
see arm description

No Intervention: 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.




Primary Outcome Measures :
  1. Uterine incision to delivery time [ Time Frame: Assessed at time of delivery, delivery day (day 0) ]
    Time (in seconds) from hysterotomy to delivery


Secondary Outcome Measures :
  1. Difficulty of Delivery of Fetal head [ Time Frame: Assessed at time of delivery, delivery day (day 0) ]
    Score of difficulty of delivery 1-5 (1: very difficult, 5: very easy)

  2. Uterine extension [ Time Frame: Assessed at time of delivery, delivery day (day 0) ]
    Grading of extension 1-3

  3. Composite Maternal Morbidity [ Time Frame: 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

  4. Length of stay [ Time Frame: Assessed at end of study period (week 4) ]
    Maternal Length of stay

  5. Fetal Weight [ Time Frame: Assessed at time of delivery, delivery day (day 0) ]
    Weight of fetus at time of birth

  6. 1 minute APGAR [ Time Frame: Assessed at time of delivery, delivery day (day 0) ]
    Assessment of the 1 minute APGAR

  7. 5 minute APGAR [ Time Frame: Assessed at time of delivery, delivery day (day 0) ]
    Assessment of the 5 minute APGAR

  8. Composite Neonatal Morbidity [ Time Frame: Assessed at end of study period (week 4) ]
    Need for intubation, fetal trauma

  9. Neonatal Intensive Care Unit (NICU) Length of Stay [ Time Frame: Assessed at end of study period (week 4) ]
    Length of stay in NICU

  10. Provider Opinions [ Time Frame: Assessed at end of study period (week 4) ]
    Willingness to recommend to others based on ease of placement and removal (1-5 point scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women undergoing cesarean section are included
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342508


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Julian N Robinson, MD Brigham and Women's Hospital, Harvard Medical School, Boston MA
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julian N Robinson, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03342508    
Other Study ID Numbers: 2017P001986
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Julian N Robinson, Brigham and Women's Hospital:
Maternal outcomes
Neonatal Outcomes
Additional relevant MeSH terms:
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Obstetric Labor Complications
Pregnancy Complications