ObesityNCT03772886
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
A study testing Peanut Ball in people with Obesity and Cesarean Section, run by Geisinger Clinic at 1 site in United States.
Trial summary
This study aims to determine if using the peanut ball during labor reduces the cesarean delivery rate when compared to normal intrapartum management (no peanut ball) in the obese patient population. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obesity, Cesarean Section
- What is being tested?
- Peanut Ball
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 9 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted for delivery
- Pre-pregnancy BMI > 30kg/m2
- Planned vaginal delivery at Geisinger Medical Center (GMC)
- Gestational age > 37 weeks 0 days
- Singleton pregnancy
- Cephalic presentation
- English speaking
Who cannot join
- Pre-pregnancy BMI < 30kg/m2
- Contraindication to vaginal delivery
- Planned cesarean delivery (i.e., an elective primary or repeat cesarean delivery)
- Gestational age < 37 weeks 0 days
- Multifetal gestation
- Intrauterine fetal demise
- Non-English speaking
- Greater than 9cm at the time of randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball: A Randomized Control Trial
This study aims to determine if using the peanut ball during labor reduces the cesarean delivery rate when compared to normal intrapartum management (no peanut ball) in the obese patient population.
Read the detailed description
Currently at Geisinger Medical Center Danville, use of the peanut ball is at the discretion of attending or resident physicians, or obstetric nurses on the Labor and delivery team for the day. Despite the common use of this labor adjuvant tool, a well-designed prospective study is necessary to investigate if the peanut ball provides any benefit during the labor process for the obese gravida. If this simple tool is shown to reduce the rate of cesarean delivery, then hospital protocols could be changed to ensure its use during labor. This has the potential to decrease the rate of cesarean delivery in the most vulnerable patient population. The investigators propose a randomized controlled trial (RCT) to determine if using the peanut ball during labor provides a reduction in the cesarean delivery rate in the obese patient population. The investigators will compare cesarean delivery rates in patients using the peanut ball to patients receiving routine intrapartum management without the use of the peanut ball. Singleton pregnancies complicated by obesity, defined by pre-pregnancy BMI > 30kg/m2, will be included.
Study participants will be randomized to one of the two study arms. The peanut ball arm (also referred to as study arm 1) will be managed according to the parameters specified for use of the peanut ball. The participants in the Control arm (also referred to as study arm 2) will be managed according to the standard intrapartum management as defined by Geisinger's Labor \& Delivery protocol and per the OB providers. The objective of the study is to determine if use of the peanut ball during labor reduces the cesarean delivery rate in the obese patient population. Secondary outcomes of interest include rate of cervical dilation, rate of operative deliveries, fetal position (occiput anterior vs. occiput posterior) at complete dilation (10 cm), and patient satisfaction.
- Conditions
- Obesity, Cesarean Section
- Being tested
- Peanut Ball
- Keywords
- Peanut Ball
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut BallDevice
A peanut shaped exercise ball.
| Study group | Role | What they receive |
|---|---|---|
| Peanut Ball Arm | Experimental | Study participants randomized to the Peanut Ball Arm will have the peanut ball placed during labor. Study participants will be required to use the peanut ball for a minimum of 30 minutes of each hour until they reach complete dilation. Peanut ball use time will be noted in the patient's chart. Receives: Device: Peanut Ball |
| Control Arm | No intervention | Study participants randomized to the Control Arm will labor without the peanut ball. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean Delivery Rate
Number of vaginal deliveries vs. Number of cesarean deliveries
Measured: Delivery
Secondary outcomes (3)
Rate of Cervical Dilation
The average amount of cervical dilation (cm) per hour compared between the two groups (peanut ball vs. no peanut ball).
Measured: Randomization until complete dilation (10cm)
Type of Vaginal Delivery
Number of spontaneous vaginal deliveries vs Number of forceps assisted vaginal deliveries vs Number of vacuum assisted vaginal deliveries.
Measured: Delivery
Fetal Position
Occiput anterior versus occiput posterior versus occiput transverse
Measured: Complete Dilation (10cm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start9 Sep 2019
- Primary completion4 Jun 2021
- Study completion9 Jun 2021
Why it stopped: Unable to complete enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Awathif Dhanya Mackeen, Geisinger Clinic
- Investigators
- Awathif D Mackeen, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772886
- Sponsor's protocol ID
- 2018-0613
- Status last verified
- Aug 2021
- First submitted
- 7 Dec 2018
- Last updated
- 23 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03772886
- Acronym / sponsor ID
- 2018-0613
- Conditions
- Obesity, Cesarean Section
- Keywords
- Peanut Ball
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to complete enrollment
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine if using the peanut ball during labor reduces the cesarean delivery rate when compared to normal intrapartum management (no peanut ball) in the obese patient population.
Detailed description
Currently at Geisinger Medical Center Danville, use of the peanut ball is at the discretion of attending or resident physicians, or obstetric nurses on the Labor and delivery team for the day. Despite the common use of this labor adjuvant tool, a well-designed prospective study is necessary to investigate if the peanut ball provides any benefit during the labor process for the obese gravida. If this simple tool is shown to reduce the rate of cesarean delivery, then hospital protocols could be changed to ensure its use during labor. This has the potential to decrease the rate of cesarean delivery in the most vulnerable patient population. The investigators propose a randomized controlled trial (RCT) to determine if using the peanut ball during labor provides a reduction in the cesarean delivery rate in the obese patient population. The investigators will compare cesarean delivery rates in patients using the peanut ball to patients receiving routine intrapartum management without the use of the peanut ball. Singleton pregnancies complicated by obesity, defined by pre-pregnancy BMI > 30kg/m2, will be included.
Study participants will be randomized to one of the two study arms. The peanut ball arm (also referred to as study arm 1) will be managed according to the parameters specified for use of the peanut ball. The participants in the Control arm (also referred to as study arm 2) will be managed according to the standard intrapartum management as defined by Geisinger's Labor \& Delivery protocol and per the OB providers. The objective of the study is to determine if use of the peanut ball during labor reduces the cesarean delivery rate in the obese patient population. Secondary outcomes of interest include rate of cervical dilation, rate of operative deliveries, fetal position (occiput anterior vs. occiput posterior) at complete dilation (10 cm), and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut Ball Arm | Experimental | Device: Peanut BallStudy participants randomized to the Peanut Ball Arm will have the peanut ball placed during labor. Study participants will be required to use the peanut ball for a minimum of 30 minutes of each hour until they reach complete dilation. Peanut ball use time will be noted in the patient's chart. |
| Control Arm | No intervention | –Study participants randomized to the Control Arm will labor without the peanut ball. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Admitted for delivery
- Pre-pregnancy BMI > 30kg/m2
- Planned vaginal delivery at Geisinger Medical Center (GMC)
- Gestational age > 37 weeks 0 days
- Singleton pregnancy
Key exclusion criteria (8 listed)
- Pre-pregnancy BMI < 30kg/m2
- Contraindication to vaginal delivery
- Planned cesarean delivery (i.e., an elective primary or repeat cesarean delivery)
- Gestational age < 37 weeks 0 days
- Multifetal gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut BallA peanut shaped exercise ball. | Device | Peanut Ball Arm |
Primary outcome
Cesarean Delivery Rate
Time frame: Delivery
Number of vaginal deliveries vs. Number of cesarean deliveries
3 secondary outcomes
Rate of Cervical Dilation
Time frame: Randomization until complete dilation (10cm)
Type of Vaginal Delivery
Time frame: Delivery
Fetal Position
Time frame: Complete Dilation (10cm)
Results and safety
The study was stopped early (reason given: Unable to complete enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Awathif D Mackeen, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanut Ball in people with Obesity and Cesarean Section, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to complete enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean Delivery Rate (time frame: Delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.