Fetal Pillow Randomized Controlled Trial

• ClinicalTrials.gov Identifier: NCT03342508
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Last Update Posted: September 19, 2019
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Julian N Robinson, Brigham and Women's Hospital

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

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

More Information

Additional Information:

Website for Fetal Pillow 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: September 19, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Obstetric Labor Complications; Pregnancy Complications