Clinical trial NCT03342508: Fetal Pillow Randomized Controlled Trial
Official title: Outcomes Following Cesarean Delivery for Failure to Progress With Use of a Fetal Pillow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Complication
Keywords: Maternal outcomes
Neonatal Outcomes
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Uterine incision to delivery time
timeFrame: Assessed at time of delivery, delivery day (day 0)
Secondary outcomes:
measure: Difficulty of Delivery of Fetal head
timeFrame: Assessed at time of delivery, delivery day (day 0)
measure: Uterine extension
timeFrame: Assessed at time of delivery, delivery day (day 0)
measure: Composite Maternal Morbidity
timeFrame: Assessed both following delivery (day 0) and at end of study period (week 4)
measure: Length of stay
timeFrame: Assessed at end of study period (week 4)
measure: Fetal Weight
timeFrame: Assessed at time of delivery, delivery day (day 0)
measure: 1 minute APGAR
timeFrame: Assessed at time of delivery, delivery day (day 0)
measure: 5 minute APGAR
timeFrame: Assessed at time of delivery, delivery day (day 0)
measure: Composite Neonatal Morbidity
timeFrame: Assessed at end of study period (week 4)
measure: Neonatal Intensive Care Unit (NICU) Length of Stay
timeFrame: Assessed at end of study period (week 4)
measure: Provider Opinions
timeFrame: Assessed at end of study period (week 4)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital, Harvard Medical School, Boston MA
name: Julian N Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.