Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636149
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Maternal Maneuvers During Prolonged Labor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CIRCUIT Maternal Maneuvers During Prolonged Labor a Pilot Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIRCUIT
Brief Summary:
This pilot randomized control trial will test whether or not a specific circuit of position changes improves maternal outcomes in cases of prolonged labor
Patient who have prolonged labor will be approached for consent and randomization to one of two study groups circuit intervention against routine standard of care position changes 82 patients will be enrolled in the study Exclusion criteria will include any uterine infection prior to randomization magnesium sulfate treatment major fetal anomalies BMI 50 non-reassuring fetal status prior to randomization or any maternal diagnosis that precludes safety or feasibility of the circuit of maternal position changes
The 3 aims of the study will include the outcome that the circuit of position changes has on the duration of the first stage of labor maternal and neonatal morbidity and maternal satisfaction
Patient who have prolonged labor will be approached for consent and randomization to one of two study groups circuit intervention against routine standard of care position changes 82 patients will be enrolled in the study Exclusion criteria will include any uterine infection prior to randomization magnesium sulfate treatment major fetal anomalies BMI 50 non-reassuring fetal status prior to randomization or any maternal diagnosis that precludes safety or feasibility of the circuit of maternal position changes
The 3 aims of the study will include the outcome that the circuit of position changes has on the duration of the first stage of labor maternal and neonatal morbidity and maternal satisfaction
Detailed Description:
To date there is an absence of data on intrapartum maternal position changes efficacy or whether a specific circuit of intrapartum maneuvers is effective We hypothesize that a nurse-informed circuit of positional maneuvers in protracted labor will significantly decrease the first stage of labor The objective of this randomized control trial will be to assess whether a specific circuit of maternal position changes in prolonged latent or active labor will decrease the first stage of labor length The three aims of this study are as follows determine the effect of a nurse-led circuit of maternal position changes versus routine care on first stage of labor duration in patients with protracted labor Compare maternal and neonatal outcomes among those with protracted labor who undergo a nurse-led circuit of maternal position changes vs routine standard of care Compare maternal satisfaction sense of control over labor process and acceptability of a circuit of maternal position changes for those who undergo a nurse-led circuit of maternal position changes vs routine standard of care
Across the country there is an emphasis to reduce cesarean delivery rates with a specific focus on reducing rates of primary cesarean deliveries in nulliparous term singleton and vertex pregnancies The most common indication for a primary cesarean delivery is labor arrest As a possible solution there has been an increased utilization of maternal position changes during labor In some cases these are specifically used in cases of a prolonged first stage of labor While these specific position changes are likely not associated with maternal or fetal harm they require significant buy in from nursing and labor and delivery staff Not only is increased time at the bedside required to execute these maneuvers but they also often require multiple members of the care team especially in patients with epidurals or obesity To date no study retrospective or prospective has evaluated the efficacy of a specific set of maternal maneuvers during prolonged first stage of labor If a specific circuit of maternal maneuvers is found to decrease the first stage of labor duration in cases of protracted labor then this would represent a significant intervention that could be offered to improve labor outcomes in patients
This studys aim is to evaluate if in cases of a prolonged first stage of labor a specific circuit of maternal position changes leads to shorter first stage of labor duration The study will be a prospective randomized pilot trial that will be conducted at Barnes Jewish Hospital in St Louis Missouri This trial design was selected to minimize confounding factors and study the effects of a circuit of maternal position changes as specifically as possible This trial will represent the first of its type to prospectively study the benefits of maternal position changes in cases of protracted labor
This study39s inclusion and exclusion criteria are listed later in this submission Patients will be approached enrolled and consented to participate upon their admission to Labor and Delivery or when they have a diagnosis of protracted labor Randomization will occur once they meet study criteria for protracted labor Randomization will be done via a computer-generated block randomization sequence in a 11 ratio of the RN-led circuit of maternal maneuvers versus routine care during the remaining portion of the patients labor course Blinding will not be possible for the nursing team or physician team caring for patient Data collection reviewers will be blinded to the participants randomization arm
Patients will be either randomized to routine care or a maternal circuit of labor position changes These arms are described in detail later in the submission
The type of maneuvers and specific order were created based on data from a nationwide survey for labor and delivery nurses regarding their personal experience and use of maneuver circuits Compliance with the circuit of position changes and deviations from the planned circuit will be tracked
Labor and delivery nurses will receive educational materials on how to perform the circuit of maternal position changes The educational materials will remain available on labor and delivery for reference Nursing stakeholders will serve as resources and provide assistance if any of their colleagues have issues with maneuvers on their shift
The rest of labor induction and labor management will continue per standard of care Oxytocin titration will be per our unit protocol If the maximum oxytocin dose is reached then consideration for oxytocin pausing and resumption will be at the primary providers discretion Oxytocin management data will be collected by research staff
During the participants postpartum stay they will be approached to complete a maternal satisfaction survey regarding their labor experience sense of control over the labor process and circuit of position changes acceptability for those who underwent the intervention The survey will be a brief easily administered 7-point Likert scale survey
Our primary outcome will be first stage of labor duration Secondary outcomes are listed later in this submission Maternal surveys regarding satisfaction sense of control over labor process and acceptability for the circuit of maternal position changes will also be a secondary outcome
Data on antenatal intrapartum and postpartum courses will be extracted from the medical record by a blinded investigator This blinded investigator will also review the electronic medical record for pre-specified neonatal outcomes after delivery Research staff will also monitor compliance with the assigned intervention and cross-over Outcomes will be assessed from delivery until discharge
Upon admission to labor and delivery or when diagnosis of protracted labor is made per study protocol patients will be approached by trained research staff members to be enrolled in the study This will be done in a private labor and delivery room Research staff members will function independently and separately from the medical team caring for the patient The patient will be given a brief introduction to the study and if they are interested in learning more the consent form will be reviewed in its entirety Any questions will be answered by research staff If once their questions have been answered the patient desires to participate they and the research team member will sign and date the informed consent form A copy will be given to the patient per standard protocol
The principal investigator PI will review all adverse events A data and safety monitoring board DSMB will also be established This board will include three individuals not involved in the study The PI will report all serious adverse events to the DSMB within 72 hours of determination of occurrence Reportable severe adverse outcomes include intrauterine fetal demise after randomization neonatal demise prior to maternal hospital discharge or maternal death after randomization Reportable non-severe adverse outcomes include intrapartum maternal fall or trauma during circuit maneuvers Aside from maternal falls during circuit maneuvers which we do not anticipate all these adverse outcomes are not-study specific All can occur albeit rarely because of labor and delivery complications or prolonged labor courses We do not anticipate that study participation would increase any of these complications but their incidence will be monitored Non-severe events will be reported to the DSMB and IRB on an annual basis Given the small sample size no interim analyses will be performed as the study will not be powered to detect differences
For data analysis intention-to-treat and per-protocol analyses will be performed Chi-squared and Fishers exact tests will be used to compare categorical variables as appropriate Continuous variables will be assessed for their distribution pattern using the Kolmogorov-Smirnov test Normally distributed variables will be compared using the students t-test and non-normally distributed variables will be analyzed with the Mann-Whitney U test A Kaplan-Meier survival curve will also be used to evaluate the primary outcome These analyses will be supplemented by multivariable logistic regressions to adjust for confounders Results with p-values ampampamplt005 will be considered statistically significant Analyses will be performed using Stata Stata Corporation College Station TX
Across the country there is an emphasis to reduce cesarean delivery rates with a specific focus on reducing rates of primary cesarean deliveries in nulliparous term singleton and vertex pregnancies The most common indication for a primary cesarean delivery is labor arrest As a possible solution there has been an increased utilization of maternal position changes during labor In some cases these are specifically used in cases of a prolonged first stage of labor While these specific position changes are likely not associated with maternal or fetal harm they require significant buy in from nursing and labor and delivery staff Not only is increased time at the bedside required to execute these maneuvers but they also often require multiple members of the care team especially in patients with epidurals or obesity To date no study retrospective or prospective has evaluated the efficacy of a specific set of maternal maneuvers during prolonged first stage of labor If a specific circuit of maternal maneuvers is found to decrease the first stage of labor duration in cases of protracted labor then this would represent a significant intervention that could be offered to improve labor outcomes in patients
This studys aim is to evaluate if in cases of a prolonged first stage of labor a specific circuit of maternal position changes leads to shorter first stage of labor duration The study will be a prospective randomized pilot trial that will be conducted at Barnes Jewish Hospital in St Louis Missouri This trial design was selected to minimize confounding factors and study the effects of a circuit of maternal position changes as specifically as possible This trial will represent the first of its type to prospectively study the benefits of maternal position changes in cases of protracted labor
This study39s inclusion and exclusion criteria are listed later in this submission Patients will be approached enrolled and consented to participate upon their admission to Labor and Delivery or when they have a diagnosis of protracted labor Randomization will occur once they meet study criteria for protracted labor Randomization will be done via a computer-generated block randomization sequence in a 11 ratio of the RN-led circuit of maternal maneuvers versus routine care during the remaining portion of the patients labor course Blinding will not be possible for the nursing team or physician team caring for patient Data collection reviewers will be blinded to the participants randomization arm
Patients will be either randomized to routine care or a maternal circuit of labor position changes These arms are described in detail later in the submission
The type of maneuvers and specific order were created based on data from a nationwide survey for labor and delivery nurses regarding their personal experience and use of maneuver circuits Compliance with the circuit of position changes and deviations from the planned circuit will be tracked
Labor and delivery nurses will receive educational materials on how to perform the circuit of maternal position changes The educational materials will remain available on labor and delivery for reference Nursing stakeholders will serve as resources and provide assistance if any of their colleagues have issues with maneuvers on their shift
The rest of labor induction and labor management will continue per standard of care Oxytocin titration will be per our unit protocol If the maximum oxytocin dose is reached then consideration for oxytocin pausing and resumption will be at the primary providers discretion Oxytocin management data will be collected by research staff
During the participants postpartum stay they will be approached to complete a maternal satisfaction survey regarding their labor experience sense of control over the labor process and circuit of position changes acceptability for those who underwent the intervention The survey will be a brief easily administered 7-point Likert scale survey
Our primary outcome will be first stage of labor duration Secondary outcomes are listed later in this submission Maternal surveys regarding satisfaction sense of control over labor process and acceptability for the circuit of maternal position changes will also be a secondary outcome
Data on antenatal intrapartum and postpartum courses will be extracted from the medical record by a blinded investigator This blinded investigator will also review the electronic medical record for pre-specified neonatal outcomes after delivery Research staff will also monitor compliance with the assigned intervention and cross-over Outcomes will be assessed from delivery until discharge
Upon admission to labor and delivery or when diagnosis of protracted labor is made per study protocol patients will be approached by trained research staff members to be enrolled in the study This will be done in a private labor and delivery room Research staff members will function independently and separately from the medical team caring for the patient The patient will be given a brief introduction to the study and if they are interested in learning more the consent form will be reviewed in its entirety Any questions will be answered by research staff If once their questions have been answered the patient desires to participate they and the research team member will sign and date the informed consent form A copy will be given to the patient per standard protocol
The principal investigator PI will review all adverse events A data and safety monitoring board DSMB will also be established This board will include three individuals not involved in the study The PI will report all serious adverse events to the DSMB within 72 hours of determination of occurrence Reportable severe adverse outcomes include intrauterine fetal demise after randomization neonatal demise prior to maternal hospital discharge or maternal death after randomization Reportable non-severe adverse outcomes include intrapartum maternal fall or trauma during circuit maneuvers Aside from maternal falls during circuit maneuvers which we do not anticipate all these adverse outcomes are not-study specific All can occur albeit rarely because of labor and delivery complications or prolonged labor courses We do not anticipate that study participation would increase any of these complications but their incidence will be monitored Non-severe events will be reported to the DSMB and IRB on an annual basis Given the small sample size no interim analyses will be performed as the study will not be powered to detect differences
For data analysis intention-to-treat and per-protocol analyses will be performed Chi-squared and Fishers exact tests will be used to compare categorical variables as appropriate Continuous variables will be assessed for their distribution pattern using the Kolmogorov-Smirnov test Normally distributed variables will be compared using the students t-test and non-normally distributed variables will be analyzed with the Mann-Whitney U test A Kaplan-Meier survival curve will also be used to evaluate the primary outcome These analyses will be supplemented by multivariable logistic regressions to adjust for confounders Results with p-values ampampamplt005 will be considered statistically significant Analyses will be performed using Stata Stata Corporation College Station TX
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None