AzTrials
AzTrials

Labor ComplicationNCT03342508

Fetal Pillow Randomized Controlled Trial

A study testing Fetal Pillow in people with Labor Complication, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Complication
What is being tested?
Fetal Pillow
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
13 Jan 2018to 1 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Fetal Pillow
Keywords
Maternal outcomes, Neonatal Outcomes
Medical subject headings
Obstetric Labor Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fetal PillowDevice

    see arm description

Study groups in NCT03342508
Study groupRoleWhat they receive
Fetal Pillow Inflated (FPI)ExperimentalA 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.
Receives: Device: Fetal Pillow
Fetal Pillow Not Inflated (FPNI)No interventionA 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Uterine incision to delivery time

    Time (in seconds) from hysterotomy to delivery

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

Secondary outcomes (10)

  1. Difficulty of Delivery of Fetal head

    Score of difficulty of delivery 1-5 (1: very difficult, 5: very easy)

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

  2. Uterine extension

    Grading of extension 1-3

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

  3. 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

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

  4. Length of stay

    Maternal Length of stay

    Measured: Assessed at end of study period (week 4)

  5. Fetal Weight

    Weight of fetus at time of birth

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

  6. 1 minute APGAR

    Assessment of the 1 minute APGAR

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

  7. 5 minute APGAR

    Assessment of the 5 minute APGAR

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

  8. Composite Neonatal Morbidity

    Need for intubation, fetal trauma

    Measured: Assessed at end of study period (week 4)

  9. Neonatal Intensive Care Unit (NICU) Length of Stay

    Length of stay in NICU

    Measured: Assessed at end of study period (week 4)

  10. Provider Opinions

    Willingness to recommend to others based on ease of placement and removal (1-5 point scale)

    Measured: Assessed at end of study period (week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study start13 Jan 2018
  3. Primary completion1 Aug 2019
  4. Study completion1 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03342508
Sponsor's protocol ID
2017P001986
Status last verified
Sep 2019
First submitted
8 Sep 2017
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 18952016

  • 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.

    PubMed 12850607

  • 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.

    PubMed 27599604

  • 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.

    PubMed 24483234

  • 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.

    PubMed 26868074

  • 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.

    PubMed 32168216

Questions about this trial

What is this clinical trial studying?

A study testing Fetal Pillow in people with Labor Complication, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uterine incision to delivery time (time frame: Assessed at time of delivery, delivery day (day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03342508, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in