Fetal Pillow Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Labor Complication
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Julian N Robinson, MD, Brigham and Women's Hospital, Harvard Medical School, Boston MA

Publications and helpful links

General Publications

• Mancuso MS, Rouse DJ. Cesarean delivery for abnormal labor. Clin Perinatol. 2008 Sep;35(3):479-90, ix. doi: 10.1016/j.clp.2008.06.004.
• Myles TD, Santolaya J. Maternal and neonatal outcomes in patients with a prolonged second stage of labor. Obstet Gynecol. 2003 Jul;102(1):52-8. doi: 10.1016/s0029-7844(03)00400-9.
• Safa H, Beckmann M. Comparison of maternal and neonatal outcomes from full-dilatation cesarean deliveries using the Fetal Pillow or hand-push method. Int J Gynaecol Obstet. 2016 Dec;135(3):281-284. doi: 10.1016/j.ijgo.2016.06.013. Epub 2016 Aug 24.
• Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J. Does elevating the fetal head prior to delivery using a fetal pillow reduce maternal and fetal complications in a full dilatation caesarean section? A prospective study with historical controls. J Obstet Gynaecol. 2014 Apr;34(3):241-4. doi: 10.3109/01443615.2013.844108. Epub 2014 Jan 31.
• Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J, Onwude JL. Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation. Int J Gynaecol Obstet. 2016 May;133(2):178-82. doi: 10.1016/j.ijgo.2015.09.019. Epub 2016 Jan 15.
• Lassey SC, Little SE, Saadeh M, Patton N, Farber MK, Bateman BT, Robinson JN. Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Apr;135(4):879-884. doi: 10.1097/AOG.0000000000003746.

Helpful Links

• Website for Fetal Pillow

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Maternal outcomes; Neonatal Outcomes
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications
• Other Study ID Numbers: 2017P001986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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