- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06443788
Trans-perineal Ultrasound in Assessment of PPROMs
Trans-perineal Ultrasound in Assessment of Preterm Pre-labor Rupture of Membranes Compared to Speculum Examination: Accuracy Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preterm pre-labor rupture of membranes (PPROM) refers to the disruption of fetal membranes before the beginning of labor, resulting in spontaneous leakage of amniotic fluid. PROM, which occurs prior to 37 weeks of gestation, defined as preterm PROM. The definition is similarly defined by ACOG, NICE, RANZCOG and World Health Organization (WHO).
PROM occurs in approximately 5%-10% of all pregnancies, of which approximately 80% occur at term.
There are numerous risk factors for PPROM, such as intrauterine infection at early gestational age, lower socioeconomic status of pregnant women, inadequate prenatal care and inadequate nutrition during pregnancy, sexually transmitted infections, vaginal bleeding, and smoking during pregnancy.
PPROM is linked to significant maternal and fetal morbidity and mortality. It has been shown to be the cause of 18%-20% and 21.4% of prenatal mortalities and morbidity respectively.
Complications of PPROM for the fetus and newborn consist of prematurity, fetal distress, cord compression, deformation and altered pulmonary development leading to pulmonary hypoplasia and pulmonary hypertension, necrotizing enterocolitis (NEC) and neurologic disorder.
Infectious morbidities in mother, fetus and newborn have been related to both PROM and prolonged rupture of membranes. Maternal complications include intra-amniotic infection, which occurs in 13%-60% of women with PROM, placental abruption, and postpartum endometritis.
Diagnosis of ROM is usually made by observing leakage of the amniotic fluid or by observing the amniotic fluid pooling in the vaginal vault.A golden standard method has not yet been defined in PROM. Diagnostic tests should be used when the diagnosis is not certain following history, examination with sterile speculum and ultrasonography evaluation. Among biochemical tests, PAMG-1 and IGFBP-1 have the features of being easily applicable tests. PAMG-1 comes into prominence with its high sensitivity and specificity. Results of tests used in PROM diagnosis must be supported by clinical findings But in Low resource settings may not have access to some tests due to their cost.
In practice, most complaints of fluid leakage are not due to membrane rupture. However, a complaint of fluid leakage warrants at least a speculum examination to check for amniotic fluid pooling. Speculum examinations are invasive and performing a speculum examination on a patient with the complaint of fluid leakage may be of no consequence when PPROM is ruled out. However, speculum examinations association with the latency periods in PPROM cases is not known and sterile vaginal examinations have been proven to shorten latency periods.
Speculum examination and digital vaginal examination are both similarly invasive in nature, and it may be possible speculum examinations can shorten latency periods as well. Women commonly experience anxiety and fear before and during a pelvic examination. Anxiety or fear has been reported in 21%- 64% of women. Additional studies have reported women experiencing embarrassment of up to 52%, anxiety in 21%-49% and pain in 22%-68%.
The hypothesis of this study is that transperineal ultrasound can be an accurate exam for diagnosis of PPROM and assess of cervical length, effacement and presenting parts in addition to umbilical cord prolapse with less patients anxiety.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maya M. Abdelrazek
- Phone Number: 01222393983
- Email: dr_maya89@med.asu.edu.eg
Study Locations
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Cairo, Egypt, 11591
- Recruiting
- Faculty of medicine, Ain shams university
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Principal Investigator:
- Peter Thabet Saeed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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 |
The following measurement will be recorded:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy in diagnosis of PPROM by trans-perineal ultrasound
Time Frame: at time of diagnosis (24 to 37 weeks' gestation)
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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
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at time of diagnosis (24 to 37 weeks' gestation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assessment of cervical length and dilatation by ultrasound (objective) in mm.
Time Frame: at time of diagnosis (24 to 37 weeks' gestation)
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comapred to speculum examination (subjective)
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at time of diagnosis (24 to 37 weeks' gestation)
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assessment of fetal parts or cord prolapse by ultrasound
Time Frame: at time of diagnosis (24 to 37 weeks' gestation)
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compared to visualization by speculum (visualizing any fetal part or cord prolapsiing from the cervix)
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at time of diagnosis (24 to 37 weeks' gestation)
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assessment of patients' anxiety (Tolerability to the examination)
Time Frame: at time of diagnosis (24 to 37 weeks' gestation)
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using State-Trait Anxiety Inventory (STAI). 1 = not at all / almost never, 2 = somewhat/sometimes, 3 = moderately so / often, and 4 = very much so / almost always
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at time of diagnosis (24 to 37 weeks' gestation)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maya M. Abdelrazek, MD, Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS 715/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Preterm Premature Rupture of Membrane
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Chelsea and Westminster NHS Foundation TrustSPD Development Company Limited; Borne CharityRecruitingPreterm Birth | Preterm Labor | Preterm Birth Complication | Preterm Premature Rupture of Membrane | Preterm PregnancyUnited Kingdom
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