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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prescribed Oxytocin (Pitocin)
37 0/7- 41 6/7 weeks of gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from epidural analgesia to delivery of the baby
Awards & highlights
Study Summary
This trial will help to determine if the peanut ball is an effective tool to reduce labor time and cesarean sections.
Who is the study for?
This trial is for first-time mothers aged 18-50, in labor or being induced, at 37-41 weeks of pregnancy. They must plan to use epidural anesthesia and have had a vaginal exam to check cervical dilation. Excluded are those in late-stage labor, outside the gestation window, with certain health conditions like hypertension or diabetes, skeletal limitations, infections, planning cesarean delivery or having multiple babies.Check my eligibility
What is being tested?
The study tests if using a peanut ball positioning device during labor can reduce time from epidural administration to full cervical dilation and decrease pushing time until delivery. It also examines if it lowers the rate of cesarean sections in women giving birth for the first time.See study design
What are the potential side effects?
There may not be direct side effects from using a peanut ball as it's a nonpharmacological tool; however discomfort or muscle strain due to positioning could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently taking Oxytocin (Pitocin).
Select...
I am between 37 and 42 weeks pregnant.
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I am a woman aged 18-50, currently in labor or about to be induced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from epidural analgesia to delivery of the baby
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from epidural analgesia to delivery of the baby
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decrease labor time
Secondary outcome measures
Decrease cesarean section deliveries
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Peanut ball interventionExperimental Treatment1 Intervention
The experimental group will receive peanut ball as positioning device during labor
Group II: standard careActive Control1 Intervention
The control group subjects will receive standard of care during labor using pillows and wedges as positional devices.
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Who is running the clinical trial?
Northwell HealthLead Sponsor
460 Previous Clinical Trials
470,445 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The baby is not in the head-down position.You are a woman currently taking magnesium sulfate.I have diabetes, including gestational diabetes.The baby is in a head-down position and there is only one baby (not twins or triplets).I am currently taking Oxytocin (Pitocin).I have had a vaginal exam to check my cervical dilation.I am between 37 and 42 weeks pregnant.Women who are planning to have a natural childbirth without pain-relieving medication (epidural).I am in the second stage of labor.I had high blood pressure problems during pregnancy.I have muscle or bone issues that prevent me from being positioned properly.I might have an infection, like an STD or another type.I am a woman aged 18-50, currently in labor or about to be induced.You are pregnant with more than one baby.You have been pregnant multiple times.
Research Study Groups:
This trial has the following groups:- Group 1: standard care
- Group 2: Peanut ball intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this research project still open?
"Affirmative. Clinicaltrials.gov has the evidence that this trial, posted on September 15th 2021, is still recruiting participants. 598 patients must be recruited from 4 medical centres to complete the study."
Answered by AI
How many facilities are conducting this experiment?
"This clinical trial consists of 8 sites, four of which are North Shore University Hospital in Manhasset, Northwell Health, Peconic Bay Medical Center in Riverhead, and Northern Westchester Hospital in Mount Kisco."
Answered by AI
What are the requirements for participation in this experiment?
"Eligibility for this clinical trial requires women in the labor force aged 18 to 50. At present, 598 participants are being sought after."
Answered by AI
What is the upper limit on enrollees for this clinical trial?
"Affirmative. The information hosted on clinicaltrials.gov asserts that recruitment for this particular medical trial is ongoing, having initially been posted in mid-September 2021 and most recently updated on the 9th of August 2022. 598 individuals need to be enrolled across 4 sites."
Answered by AI
Is this research project accepting individuals aged 60 and over?
"This investigation has predetermined that the minimum age for enrolment is 18, while the maximum allowable age of participants is 50."
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