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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen and Infants Hospital of Rhode Island

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Maternal age >18

Term gestation (>37 weeks)

Singleton pregnancy

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

Disqualifiers

Multiple gestations

Unanesthetized labor

Known fetal anomalies

Known intrauterine fetal demise

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Side-lying peanut ball groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Operative Delivery Rate

The combined rate of cesarean and instrumental vaginal deliveries in each study group

Time frame
Enrollment in active labor through delivery, on average 12 hours

Secondary outcomes

1

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

Time frame
Enrollment in active labor through delivery, on average 12 hours
2

Rotation at Delivery

The percent of fetuses that rotate to facing downwards (occiput anterior, OA) at the time of delivery in each study group

Time frame
Enrollment in active labor through delivery, on average 12 hours
3

Duration of Active Second Stage

The mean amount of time spent pushing during the second stage of labor in each group (measured in minutes)

Time frame
Onset of second stage of labor to delivery, up to 4 hours
4

Estimated Blood Loss

The mean amount of blood loss incurred at delivery in each study group (measured in mL)

Time frame
Time of delivery to 24 hours postpartum

Other outcomes

Sponsors and contacts

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