Using trans-perineal ultrasound to assess preterm premature rupture of membranes
Trans-perineal Ultrasound in Assessment of Preterm Pre-labor Rupture of Membranes Compared to Speculum Examination: Accuracy Study
NA · Ain Shams University · NCT06443788
This study is testing a new ultrasound method to see if it can help pregnant women with symptoms of early water breaking get a quicker and safer diagnosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06443788 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the diagnosis of preterm premature rupture of membranes (PPROM) by utilizing trans-perineal ultrasound as a non-invasive alternative to traditional speculum examinations. By minimizing patient anxiety and reducing the risk of infection, the study seeks to provide a more accurate and timely assessment of PPROM in pregnant women. The methodology involves evaluating pregnant women between 24 to 37 weeks of gestation who exhibit symptoms suggestive of PPROM. The goal is to enhance maternal and fetal outcomes by ensuring better diagnostic practices.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women between 24 to 37 weeks of gestation with symptoms indicative of PPROM.
Not a fit: Patients who are in active labor, have vaginal bleeding, or have other specified exclusions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of PPROM, reducing complications for both mothers and their babies.
How similar studies have performed: While the use of trans-perineal ultrasound is a relatively novel approach in this context, similar studies have shown promise in improving diagnostic accuracy in obstetric care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * 24 to 37 weeks' gestation. Exclusion Criteria: * • 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).
Where this trial is running
Cairo
- Faculty of Medicine, Ain Shams University — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Maya M. Abdelrazek, MD — Ain Shams University
- Study coordinator: Maya M. Abdelrazek
- Email: dr_maya89@med.asu.edu.eg
- Phone: 01222393983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PPROM, Preterm Premature Rupture of Membrane, transperineal ultrasound, speculum exmaination