NCT03342508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 13, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

September 8, 2017

Last Update Submit

September 18, 2019

Conditions

Labor Complication

Keywords

Maternal outcomesNeonatal Outcomes

Outcome Measures

Primary Outcomes (1)

  • Uterine incision to delivery time

    Time (in seconds) from hysterotomy to delivery

    Assessed at time of delivery, delivery day (day 0)

Secondary Outcomes (10)

  • Difficulty of Delivery of Fetal head

    Assessed at time of delivery, delivery day (day 0)

  • Uterine extension

    Assessed at time of delivery, delivery day (day 0)

  • Composite Maternal Morbidity

    Assessed both following delivery (day 0) and at end of study period (week 4)

  • Length of stay

    Assessed at end of study period (week 4)

  • Fetal Weight

    Assessed at time of delivery, delivery day (day 0)

  • +5 more secondary outcomes

Study Arms (2)

Fetal Pillow Inflated (FPI)

EXPERIMENTAL

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

Fetal Pillow Not Inflated (FPNI)

NO INTERVENTION

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.

Interventions

Fetal PillowDEVICE

see arm description

Fetal Pillow Inflated (FPI)

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women undergoing cesarean section are included
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • breech presentation
  • presence of contraindication to vaginal delivery
  • prior cesarean section
  • presence of congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

  • 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.

    PMID: 18952016RESULT

  • 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.

    PMID: 12850607RESULT

  • 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.

    PMID: 27599604RESULT

  • 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.

    PMID: 24483234RESULT

  • 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.

    PMID: 26868074RESULT

  • 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.

    PMID: 32168216DERIVED

Related Links

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Julian N Robinson, MD

    Brigham and Women's Hospital, Harvard Medical School, Boston MA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2017

First Posted

November 17, 2017

Study Start

January 13, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)