An interventional study of Fetal Pillow in Labor Complication, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Prevention
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Among 26 studies in Obstetric Labor Complications with a site in United States — 9 open to participants now, 9 under way, none of them phase 3. Obstetric Labor Complications · United States.
Among the 26 studies in Obstetric Labor Complications with a site in United States, this one is the 15th largest by enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2018, is one of 14 with no phase, and was the 6th registered.
88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.
Browse Obstetric Labor Complications studies →9 of the 26 studies in Obstetric Labor Complications with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 0 days–9 mo
University of Oklahoma · Sites in United States
Ages 15–45 · Women only
Women and Infants Hospital of Rhode Island · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Oregon Health and Science University · Sites in United States
Ages 18–65 · Women only · Healthy volunteers
Washington University School of Medicine · Sites in United States
Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 18 Obstetric Labor Complications studies recruiting now, 7 (39%) set no upper age limit and 9 (50%) stop at 75 or younger; 4 take children under 18; 11 take healthy volunteers.
This study: 18 Years to 50 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 2 · Phase 4 1
First in 2002; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 60 is below the median of 159 across 63 interventional studies indexed under Obstetric Labor Complications.
Median enrollment 95 across the 20 interventional studies, 280 across the 6 observational. Of the 17 that completed or were terminated, 7 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 26 has an industry lead sponsor. The 10 most frequent:
Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Brigham and Women's Hospital has 1 study filed under Obstetric Labor Complications — fewer than ten, so there is no comparison to draw.
2 of the studies in Obstetric Labor Complications with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04303702Washington University School of MedicineThe Role of Oxytocin in the Second Stage of Labor | 2027-06-01 |
| NCT05264779Indiana UniversityThe Periviable GOALS Decision Support Tool | 2027-11 |
Add all 2 to your calendar (.ics) → With an account.
Among the 26 studies in Obstetric Labor Complications with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
see arm description
Uterine incision to delivery time
Time (in seconds) from hysterotomy to delivery
Time frame: Assessed at time of delivery, delivery day (day 0)
Difficulty of Delivery of Fetal head
Score of difficulty of delivery 1-5 (1: very difficult, 5: very easy)
Time frame: Assessed at time of delivery, delivery day (day 0)
Uterine extension
Grading of extension 1-3
Time frame: Assessed at time of delivery, delivery day (day 0)
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
Time frame: Assessed both following delivery (day 0) and at end of study period (week 4)
Length of stay
Maternal Length of stay
Time frame: Assessed at end of study period (week 4)
Fetal Weight
Weight of fetus at time of birth
Time frame: Assessed at time of delivery, delivery day (day 0)
1 minute APGAR
Assessment of the 1 minute APGAR
Time frame: Assessed at time of delivery, delivery day (day 0)
5 minute APGAR
Assessment of the 5 minute APGAR
Time frame: Assessed at time of delivery, delivery day (day 0)
Composite Neonatal Morbidity
Need for intubation, fetal trauma
Time frame: Assessed at end of study period (week 4)
Neonatal Intensive Care Unit (NICU) Length of Stay
Length of stay in NICU
Time frame: Assessed at end of study period (week 4)
Provider Opinions
Willingness to recommend to others based on ease of placement and removal (1-5 point scale)
Time frame: Assessed at end of study period (week 4)
Plan to share: No
Ran from Jan 2018 to primary completion in Aug 2019, 18 months.
Of 27 interventional studies with no phase under Obstetric Labor Complications, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's 18 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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