Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443788
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-27
Brief Title:
Trans-perineal Ultrasound in Assessment of PPROMs
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Trans-perineal Ultrasound in Assessment of Preterm Pre-labor Rupture of Membranes Compared to Speculum Examination Accuracy Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 thats 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
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 214 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 vaultA 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
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 214 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 vaultA 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None