Clinical trial NCT06636149: Maternal Maneuvers During Prolonged Labor
Official title: CIRCUIT: Maternal Maneuvers During Prolonged Labor, a Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Stage, First
Prolonged Labor
Keywords: Circuit
Position changes
Labor
Prolonged labor
Labor dystocia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
name: The Foundation for Barnes-Jewish Hospital
First posted: 2024-10-10
Enrollment: 82
Sex: FEMALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 study's 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 study\&#39;s 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 1:1 ratio of the RN-led circuit of maternal maneuvers versus routine care during the remaining portion of the patient's 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 participant's 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 provider's discretion. Oxytocin management data will be collected by research staff.

During the participant's 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 Fisher's 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 student's 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 \&amp;amp;amp;lt;0.05 will be considered statistically significant. Analyses will be performed using Stata (Stata Corporation, College Station, TX).

Eligibility criteria: Inclusion Criteria:

* English-speaking patients
* Singleton, vertex pregnancies
* 34 weeks' gestation or later
* Admitted to Labor and Delivery in spontaneous labor or for an induction of labor
* Prolonged labor course as defined by: cervical dilation less than 6 cm after 8 hours or more of ruptured membranes (spontaneous or artificial) and oxytocin infusion, or cervical dilation 6 cm or more and less than 1-cm cervical dilation change over 2 hours or more with ruptured membranes and oxytocin infusion

Exclusion Criteria:

* Intraamniotic infection prior to randomization
* Magnesium sulfate treatment
* Major fetal anomalies
* BMI ≥50
* Non-reassuring fetal status prior to randomization
* Any maternal diagnosis that precludes safety or feasibility of intrapartum circuit of maternal position changes

Primary outcomes:
measure: First stage of labor duration
timeFrame: From enrollment until delivery
Secondary outcomes:
measure: Mode of delivery
timeFrame: Enrollment to delivery
measure: Cesarean section indication
timeFrame: Enrollment to delivery
measure: Length of labor
timeFrame: Enrollment to delivery
measure: Length of active labor
timeFrame: Time from 6cm of cervical dilation to 10cm of cervical dilation or delivery
measure: Length of latent labor
timeFrame: Admission until active labor (cervix 6cm or greater) or delivery
measure: Length of second stage of labor
timeFrame: 10cm of cervical dilation to delivery
measure: Time from randomization to delivery
timeFrame: Time from randomization to delivery
measure: Time from randomization to second stage of labor
timeFrame: Time from randomization until patient achieves 10cm cervical dilation
measure: Composite maternal morbidity
timeFrame: Enrollment to postpartum discharge
measure: Composite Neonatal Morbidity
timeFrame: From delivery until neonatal discharge or 1 month of life (whichever comes first)
Other outcomes:
Locations:
city: Saint Loius
country: United States
facility: Washington University Medicine
state: Missouri
Study officials:
References:
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