Trans-perineal Ultrasound in Assessment of PPROMs

NCT06443788 | Completed

• 1 other identifier: MS 715/2023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Accurate and timely diagnosis of preterm pre-labor rupture of membranes (PPROM) is important to prevent adverse maternal and fetal outcomes. Following a history of PPROM, physical examination should be performed in a way that minimizes the risk of infection using a speculum. This is important to confirm the diagnosis by visualizing the amniotic fluid passing from the cervical canal or pooling in the vagina. In addition to examining the cervix to assess its dilatation and effacement and look for umbilical cord prolapse or fetal prolapse. However, Pelvic exam is one of the most common anxiety provoking medical procedures that's why this study aims at using the transperineal ultrasound as a non-invasive, accurate, cost effective, applicable and readily available tool in assessment of PPROM with less patient anxiety and fear.

Conditions

PPROM; Preterm Premature Rupture of Membrane

Keywords

transperineal ultrasound; speculum exmaination; PPROM

Outcome Measures

Primary Outcomes (1)

• Accuracy in diagnosis of PPROM by trans-perineal ultrasound

  Images by ultrasound will be evaluated for appearance of accumulated hypoechogenic fluid around cervix. Whenever collection is spotted, three largest dimensions of fluid will be measured (length, width, depth) comparing it to speculum examination by observing amniotic fluid leaking through the cervix or pooling of amniotic fluid in posterior vaginal vault

  at time of diagnosis (24 to 37 weeks' gestation)

Secondary Outcomes (3)

• assessment of cervical length and dilatation by ultrasound (objective) in mm.

  at time of diagnosis (24 to 37 weeks' gestation)

• assessment of fetal parts or cord prolapse by ultrasound

  at time of diagnosis (24 to 37 weeks' gestation)

• assessment of patients' anxiety (Tolerability to the examination)

  at time of diagnosis (24 to 37 weeks' gestation)

Study Arms (1)

Pregnant women with history suggestive of PPROMs between 24 to 37 weeks' gestation

Evaluation of amniotic fluid pooling via transperineal ultrasonography will be performed. Images will be captured in sagittal and transverse planes. Sagittal plane images will be captured with ultrasound probe placed in between labia major, parallel to their long axis. Transverse plane images will be captured with ultrasound probe placed on posterior fourchette, parallel to the plane of posterior. Images will be evaluated for appearance of accumulated hypoechogenic fluid around cervix. Whenever collection is spotted, three largest dimensions of fluid will be measured (length, width, depth). Fluid accumulations around the cervix that are clearly demarcated from surrounding tissues were considered positive. Cervical length detected . Presenting part and cord prolapse

Diagnostic Test: transperineal ultrasound

Interventions

transperineal ultrasound DIAGNOSTIC_TEST

The following measurement will be recorded: 1. Amniotic fluid pooling assessment will be performed in sagittal and transverse planes. , * Images will be evaluated for appearance of accumulated hypoechogenic fluid around cervix. Whenever collection is spotted, three largest dimensions of fluid will be measured (length, width, depth). * Fluid accumulations around the cervix that are clearly demarcated from surrounding tissues will be considered positive. 2. Cervical length: it will be measured between the internal os point to the external os point below. Cervical dilatation will be measured in a transverse plane from inner to inner. 3. Presence of fetal part prolapse and/or cord prolapse

Pregnant women with history suggestive of PPROMs between 24 to 37 weeks' gestation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women with a history suggestive of preterm prelabor rupture of membranes (PPROM) presenting to the emergency ward or the outpatient clinic at Ain Shams University Maternity Hospital.

You may qualify if:

• Pregnant women with history suggestive of preterm prelabor rupture of membranes (PPROM):
• Sudden gush of fluid per vagina or.
• Continuous leakage of fluid per vagina or.
• Feeling wet or.
• Feeling inability to stop urinating.
• to 37 weeks' gestation.

You may not qualify if:

• Women in active labor (uterine contraction with cervical dilatation more than or equal to 5 cm).
• Women with vaginal bleeding.
• Vulvovaginitis (vaginal discharge).
• Cervical cerclage in place.
• Intrauterine fetal demise (IUFD).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Study Officials

• Maya M. Abdelrazek, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 5, 2024
• Study Start: June 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)