Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
Healthy Volunteers
ID06261710

Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

Led by Larry Hinkson · Updated on 2024-02-16

356

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

This research aims to find out if using ultrasound during labor can reduce infections compared to the usual internal vaginal examinations. It focuses on pregnant women in labor, studying whether non-invasive ultrasound monitoring can lead to fewer cases of clinical chorioamnionitis, a type of infection. Secondary goals include looking at overall birth outcomes and how satisfied mothers are with their care. Participants are randomly assigned to one of two groups. One group is monitored during labor using ultrasound measurements such as Angle of Progression, Head Perineum Distance, Midline Angle, and Cervix Dilatation every 3 to 4 hours until delivery. The other group receives the traditional care of internal vaginal examinations at similar intervals. This comparison helps assess whether ultrasound alone can safely guide labor progress. During the study, researchers track signs of infection like fever, rapid heart rates, uterine tenderness, and amniotic fluid odor from admission until delivery. They also collect information on delivery type, newborn health, and maternal satisfaction. Assessments include measuring maternal age, weight, height, pregnancy weeks, previous pregnancies, and neonatal weight shortly after birth. The study follows participants through labor and up to six weeks after delivery, including monitoring antibiotic use and blood loss.

CONDITIONS

Brief Title

Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations

Who Can Participate

Age: 18Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women at least 18 years old with a single baby in head-first position
  • Labor started naturally or births after labor induction meeting other criteria
  • Able to give consent to participate
Not Eligible

You will not qualify if you...

  • Emergency situations like heavy maternal or fetal bleeding
  • Need for urgent cesarean delivery
  • Abnormal fetal heart monitoring (pathological cardiotocogram)
  • Baby in non-head-first positions
  • Under 18 years of age
  • Women unable to give consent to participate

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From admission until delivery

Participants are monitored during labor using either non-invasive ultrasound parameters or traditional internal vaginal examinations to assess labor progress from admission until delivery.

Assessments every 3 to 4 hours during labor

Follow-up

Duration - Up to 6 weeks postpartum

Participants and their newborns are observed after delivery to assess maternal and neonatal outcomes, including neonatal admission and maternal recovery.

Visits up to 6 weeks after delivery

Trial Site Locations

Total: 1 location

1

Charité University Hospital

Berlin, Germany

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Research Team

L

Larry Hinkson, FRCOG

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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