Ultrasound Prediction of POPP in Active Labor

NCT05910359 | Unknown

• 1 other identifier: 5830
• Study Type: interventional
• Target: 593
• Locations: 0 countries
• Sites: N/A

Brief Summary

Persistent occiput posterior position (POPP) represents a relevant risk factor for various adverse outcomes: prolonged labor, higher incidence of operative delivery and/or cesarean section for non-reassuring fetal conditions, higher incidence of high-grade perineal tears (OASIS). For such reasons, labor with POPP needs particular and non-routinary attention. Hence, it is important to diagnose in advance fetuses who present POPP to assure more adequate assistance in labor. Furthermore, digital examination shows a lower detection rate for such condition if compared to ultrasound in labor. This multicenter prospective cross-sectional interventional study aims to evaluate the occiput position and the descent of the fetal head at the beginning of active labor to predict POPP at delivery. All the participants will be subjected to transabdominal and transperineal ultrasound at the beginning of active labor (between 3 and 8 cm of cervical dilatation) to evaluate the position of the fetal head and its descent. At the delivery, the position of the fetal head and the features of the second stage of the labor will be recorded.

Conditions

Labor Complication; Fetal Head to Enter Pelvic Brim; Failure, Affecting Fetus or Newborn

Outcome Measures

Primary Outcomes (1)

• the incidence of POPP in the study population

  How many POPP in labor

  1 year

Study Arms (2)

Persistent Occiput Posterior Position

EXPERIMENTAL

transabdominal and transperineal ultrasound by expert sonographers

Diagnostic Test: Ultrasound

Anterior Occiput Position at delivery

ACTIVE COMPARATOR

transabdominal and transperineal ultrasound by expert sonographers

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

transabdominal and transperineal ultrasound by expert sonographers

Anterior Occiput Position at delivery; Persistent Occiput Posterior Position

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 y.o.;
• Pregnant women with diagnosis of active labor, admitted to delivery room;
• Singleton;
• At term (\>37 weeks);
• Cephalic presentation;
• Signed written informed consent to study participation.

You may not qualify if:

• Age \<18 y.o.;
• Preterm deliveries;
• Multiple pregnancies;
• Elective cesarean section;
• Non-cephalic presentation;
• Incomplete obstetrical data;
• Refusal to provide informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Obstetric Labor Complications

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multicenter prospective cross-sectional interventional study without drug nor device

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: June 15, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 15, 2024
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share