PPROMNCT06443788
Trans-perineal Ultrasound in Assessment of PPROMs
An observational study of PPROM and Preterm Premature Rupture of Membrane, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- PPROM, Preterm Premature Rupture of Membrane
- What is being tested?
- transperineal ultrasound
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- • 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trans-perineal Ultrasound in Assessment of Preterm Pre-labor Rupture of Membranes Compared to Speculum Examination: Accuracy Study
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.
Read the 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.
- Conditions
- PPROM, Preterm Premature Rupture of Membrane
- Being tested
- transperineal ultrasound
- Keywords
- transperineal ultrasound, speculum exmaination, PPROM
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transperineal ultrasoundDiagnostic test
The following measurement will be recorded:
- 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.
- 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.
- Presence of fetal part prolapse and/or cord prolapse
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: transperineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at time of diagnosis (24 to 37 weeks' gestation)
Secondary outcomes (3)
assessment of cervical length and dilatation by ultrasound (objective) in mm.
comapred to speculum examination (subjective)
Measured: at time of diagnosis (24 to 37 weeks' gestation)
assessment of fetal parts or cord prolapse by ultrasound
compared to visualization by speculum (visualizing any fetal part or cord prolapsiing from the cervix)
Measured: at time of diagnosis (24 to 37 weeks' gestation)
assessment of patients' anxiety (Tolerability to the examination)
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
Measured: at time of diagnosis (24 to 37 weeks' gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jun 2024
- Primary completion1 Feb 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPROMStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Abdelrazek, Ain Shams University
- Investigators
- Maya M. Abdelrazek, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443788
- Sponsor's protocol ID
- MS 715/2023
- Status last verified
- Jun 2025
- First submitted
- 27 May 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-perineal Ultrasound in Assessment of Preterm Pre-labor Rupture of Membranes Compared to Speculum Examination: Accuracy Study
- ClinicalTrials.gov ID
- NCT06443788
- Acronym / sponsor ID
- MS 715/2023
- Conditions
- PPROM, Preterm Premature Rupture of Membrane
- Keywords
- transperineal ultrasound, speculum exmaination, PPROM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with history suggestive of PPROMs between 24 to 37 weeks' gestation | – | Diagnostic Test: transperineal ultrasoundEvaluation 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- Pregnant women with history suggestive of preterm prelabor rupture of membranes (PPROM):
- 24 to 37 weeks' gestation.
Key exclusion criteria (5 listed)
- • Women in active labor (uterine contraction with cervical dilatation more than or equal to 5 cm).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transperineal ultrasoundThe 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 | Diagnostic test | Pregnant women with history suggestive of PPROMs between 24 to 37 weeks' gestation |
Primary outcome
Accuracy in diagnosis of PPROM by trans-perineal ultrasound
Time frame: at time of diagnosis (24 to 37 weeks' gestation)
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
3 secondary outcomes
assessment of cervical length and dilatation by ultrasound (objective) in mm.
Time frame: at time of diagnosis (24 to 37 weeks' gestation)
assessment of fetal parts or cord prolapse by ultrasound
Time frame: at time of diagnosis (24 to 37 weeks' gestation)
assessment of patients' anxiety (Tolerability to the examination)
Time frame: at time of diagnosis (24 to 37 weeks' gestation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya M. Abdelrazek, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PPROM and Preterm Premature Rupture of Membrane, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy in diagnosis of PPROM by trans-perineal ultrasound (time frame: at time of diagnosis (24 to 37 weeks' gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.