Fetal Pillow Randomized Controlled Trial

Labor Complication Clinical Trial

Official title:

Outcomes Following Cesarean Delivery for Failure to Progress With Use of a Fetal Pillow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03342508
• Other study ID #: 2017P001986
• Status: Completed
• Phase: N/A
• Start date: January 13, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: September 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Complication
• Obstetric Labor Complications

Intervention

Device:
• Fetal Pillow
see arm description

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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 — View 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 G — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine incision to delivery time	Time (in seconds) from hysterotomy to delivery	Assessed at time of delivery, delivery day (day 0)
Secondary	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)
Secondary	Uterine extension	Grading of extension 1-3	Assessed at time of delivery, delivery day (day 0)
Secondary	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)
Secondary	Length of stay	Maternal Length of stay	Assessed at end of study period (week 4)
Secondary	Fetal Weight	Weight of fetus at time of birth	Assessed at time of delivery, delivery day (day 0)
Secondary	1 minute APGAR	Assessment of the 1 minute APGAR	Assessed at time of delivery, delivery day (day 0)
Secondary	5 minute APGAR	Assessment of the 5 minute APGAR	Assessed at time of delivery, delivery day (day 0)
Secondary	Composite Neonatal Morbidity	Need for intubation, fetal trauma	Assessed at end of study period (week 4)
Secondary	Neonatal Intensive Care Unit (NICU) Length of Stay	Length of stay in NICU	Assessed at end of study period (week 4)
Secondary	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)

External Links

•   Website for Fetal Pillow