RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-05-01
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05881629

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Maternal age \>18
  2. * Term gestation (\>37 weeks)
  3. * Singleton pregnancy
  4. * Spontaneous or induced active labor (cervical dilation 6-9cm)
  5. * Epidural anesthesia
  6. * Cephalic fetal presentation, OP/OT position diagnosed by bedside ultrasound
  7. * Continuous external fetal monitoring
  8. * Ability to consent
  1. * Multiple gestations
  2. * Unanesthetized labor
  3. * Known fetal anomalies
  4. * Known intrauterine fetal demise
  5. * Inability to consent

Contacts and Locations

Study Contact

Kathryn M Anderson, MD
CONTACT
401-274-1100
kathryn.anderson24@gmail.com
Alexis Gimovsky, MD
CONTACT
agimovsky@kentri.org

Principal Investigator

Alexis Gimovsky, MD
PRINCIPAL_INVESTIGATOR
Women and Infant's Hospital of Rhode Island

Study Locations (Sites)

Women and Infant's Hospital of Rhode Island
Providence, Rhode Island, 02905
United States

Collaborators and Investigators

Sponsor: Women and Infants Hospital of Rhode Island

  • Alexis Gimovsky, MD, PRINCIPAL_INVESTIGATOR, Women and Infant's Hospital of Rhode Island

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2026-09-01

Terms related to this study

Keywords Provided by Researchers

  • fetal malposition
  • occiput posterior
  • occiput transverse

Additional Relevant MeSH Terms

  • Cesarean Delivery Affecting Fetus
  • Labor Dystocia
  • Labor Complication