Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery

Labor Complication Clinical Trial

Official title:

Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05881629
• Other study ID #: 2015598-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 28, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Women and Infants Hospital of Rhode Island
• Contact: Kathryn M Anderson, MD
• Phone: 401-274-1100
• Email: kathryn.anderson24[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

• In fetuses who are facing upwards (occiput posterior, OP) or sideways (occiput transverse, OT) during labor, does changing the patient's position during active labor to a side-lying posture with a peanut ball increase the chances of them having a successful, spontaneous vaginal delivery?

• Does changing the patient's position in active labor affect the position of the baby at the time of delivery?

• Do intentional position changes in labor impact patient-perceived autonomy during their labor and delivery experience?

Participants will:

• Receive an ultrasound during labor to determine the position of their baby

• Be asked to adopt a specific position in labor (side-lying with peanut ball) if they are randomized to the study group

• Receive additional ultrasounds during labor to assess their baby's position

• Fill out a questionnaire about their labor experience following the delivery of their baby

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Maternal age >18

• Term gestation (>37 weeks)

• Singleton pregnancy

• Spontaneous or induced active labor (cervical dilation 6-9cm)

• Epidural anesthesia

• Cephalic fetal presentation, OP/OT position diagnosed by bedside ultrasound

• Continuous external fetal monitoring

• Ability to consent

Exclusion Criteria:

• Multiple gestations

• Unanesthetized labor

• Known fetal anomalies

• Known intrauterine fetal demise

• Inability to consent

Related Conditions & MeSH terms

• Cesarean Delivery Affecting Fetus
• Dystocia
• Labor Complication
• Labor Dystocia
• Obstetric Labor Complications

Intervention

Behavioral:
• Maternal position change to side-lying lateral with peanut ball
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.
• Free maternal position
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Rotation at Delivery	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Apgar Scores	Mean Apgar Score at 1 and 5 minutes for fetuses delivered in each study group	Time of delivery to 5 minutes postpartum
Secondary	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