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The goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally.
Specifically, it aims to answer the questions:
Participants will:
In this randomized trial, the investigators aim to evaluate the effects of early ultrasound diagnosis and active management of fetal malposition during the first stage of labor. Specifically, the investigators will compare the modified Sims (side-lying) position ipsilateral to fetal spine with the addition of a peanut ball versus free maternal position choice in occiput posterior (OP) or occiput transverse (OT) fetuses diagnosed by ultrasound during active labor, defined as greater than 6cm cervical dilation. The primary outcome will be operative delivery rates, defined as either cesarean delivery or instrumental vaginal delivery with vacuum or forceps. The investigators will also assess rates of spontaneous rotation to occiput anterior (OA) position at complete dilation and at delivery, as well as the impact of the position changes on the patient's labor experience and their perceived autonomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Side-lying peanut ball group | Experimental | Participants randomized to this group will be asked to adopt a side-lying, lateral position on the ipsilateral side of the fetal spine. A peanut ball will be positioned between the participant's legs while in this position. They will be asked to maintain this position for 60 minutes. |
|
| Control group | Placebo Comparator | Participants randomized to this group will be able to adopt any position of their choosing during the 60-minute study period. They will not be able to use a peanut ball during this time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maternal position change to side-lying lateral with peanut ball | Behavioral | Participants will be assisted into a position lying on their side, specifically the same side as the fetal spine diagnosed by ultrasound. An inflated peanut ball will be positioned between the legs to open the pelvis. They will be asked to maintain the position for 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Delivery Rate | The combined rate of cesarean and instrumental vaginal deliveries in each study group | Enrollment in active labor through delivery, on average 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rotation at Complete Dilation | The percent of fetuses that rotate to facing downwards (occiput anterior) at the time of complete cervical dilation (10cm) in each study group | Enrollment in active labor through delivery, on average 12 hours |
| Rotation at Delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn M Anderson, MD | Contact | 401-274-1100 | kathryn.anderson24@gmail.com | |
| Alexis Gimovsky, MD | Contact | agimovsky@kentri.org |
| Name | Affiliation | Role |
|---|---|---|
| Alexis Gimovsky, MD | Women and Infant's Hospital of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Infant's Hospital of Rhode Island | Recruiting | Providence | Rhode Island | 02905 | United States |
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Intervention group (side-lying position with peanut ball) versus control group (free position choice, no peanut ball)
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| Free maternal position | Behavioral | Participants will be asked to adopt any position of their choosing and to maintain it for 60 minutes. They will be asked to not use a peanut ball during the 60 minute study period. |
|
The percent of fetuses that rotate to facing downwards (occiput anterior, OA) at the time of delivery in each study group |
| Enrollment in active labor through delivery, on average 12 hours |
| Duration of Active Second Stage | The mean amount of time spent pushing during the second stage of labor in each group (measured in minutes) | Onset of second stage of labor to delivery, up to 4 hours |
| Estimated Blood Loss | The mean amount of blood loss incurred at delivery in each study group (measured in mL) | Time of delivery to 24 hours postpartum |
| Degree of Laceration following Delivery | The percent of each degree of vaginal laceration (first, second, third, fourth) sustained during vaginal delivery in each study group | Time of delivery to admission to postpartum unit, on average 2 hours |
| Score on Labor Agentry Scale | The mean score on the validated Labor Agentry Scale (LAS) in each study group, which measures the degree that the participant felt in control during their labor process. Possible total scores for the Labor Agentry Scale range from 10 (rarely felt in control) to 70 (almost always felt in control). | Time of delivery to discharge from hospital, on average 2 days |
| Apgar Scores | Mean Apgar Score at 1 and 5 minutes for fetuses delivered in each study group | Time of delivery to 5 minutes postpartum |
| Neonatal Intensive Care Unit (NICU) Admission | Rates of NICU admission following delivery in each study group | Time of delivery to up to 6 weeks postpartum |
| ID | Term |
|---|---|
| D004420 | Dystocia |
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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