Fetal Membranes, Premature RuptureNCT02380560
Myometrial Thickness as a Predictor for the Latency Interval in PPROM
An observational study of Fetal Membranes, Premature Rupture, run by Cairo University at 1 site in Egypt.
Trial summary
100 women divided into 3 groups: Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50) with gestational age from 24 to 34 weeks. Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Membranes, Premature Rupture
- What is being tested?
- Ultrasonographic examination
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to Feb 2019
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The total number of pregnant women will be enrolled in the study is 100 women. These wwill be divided into three groups: * Group I: includes 50 women with preterm premature rupture of membranes (PPROM, n=50) with gestational age from 24 to 34 weeks. * Group II: includes 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks. * Group III: includes 25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks.
Who may be able to join
- singleton pregnancy with a definite history of current PPROM for the study group
Who cannot join
- Suspected fetal growth restriction (IUGR),
- Any gross fetal anomalies,
- Abnormalities of placentation,
- Uterine structural abnormalities,
- Fetal jeopardy or intrauterine fetal death (IUFD).
- Women presenting with chorioamniointis with fever over 38 c abdominal tenderness, foul vaginal discharge and/or fetal tachycardia.
Show all 9Show fewer
- Diabetics, immunocompromized and cardiac patients.
- Women with cervical cerclage.
- Women with drained liquor
Trial locations and contacts
1 site in 1 country.
Aly Abdelhafiz, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: Sonographic Assessment of Myometrial Thickness as a Predictor for the Latency Interval in Women With Preterm Premature Rupture of Membranes
100 women divided into 3 groups:
- Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50) with gestational age from 24 to 34 weeks.
- Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks.
- Group III: included 25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks.The myometrial thickness at 4 different sites9:
Read more
- The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan probe perpendicularly above the uterine fundus so that the entire curvature of the uterus was visualized. (d)The posterior wall: through using the maternal abdominal aortic pulsation as an anatomic marker.
At least 3 measurements were obtained at each site and averaged. The latency interval is determined in each of the 3 groups.
Read the detailed description
The total number of pregnant women enrolled in the study was 100 women. These were divided into three groups:
- Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50) with gestational age from 24 to 34 weeks.
- Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks.
- Group III: included 25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks.Full History taking, including personal history for maternal age, obstetric history for number of previous pregnancies, history of previous PPROM. History of present pregnancy included gestational age, history of drug intake with special emphasis to women with PPROM giving history of gush of clear watery fluid from the vagina. Past history to exclude women with a contra- indication for conservative management in the study group.
Physical examinations: General examination for pulse, arterial blood pressure and temperature to exclude any signs of chorioamnionitis in the study group.
Abdominally, fundal level examinations for predicting the gestational age and/or IUGR or abnormalities of liquor. Monitoring of uterine contraction to pick up women who are not in labor in the study group.
P/V examination was not done for the three groups. While definite diagnosis of PPROM relied on sterile speculum examination showing a collection of fluid in the vagina. Some women needed direct observation of the cervix during a valsulva maneuver or with cough to show free flow of fluid from the cervical os.
Ultrasonographic examination: An abdominal ultrasound for: Estimation of gestational age, Assessment of fetal well being by biophysical profile (BPP), Detection of any fetal gross anomalies, Assessment of fetal growth to exclude IUGR, Sonographic estimation of fetal weight (SEFW), measurement of the Amniotic Fluid Index (AFI), Detection of any abnormal placental insertion and/or uterine structural abnormalities as septate or bicornuate uterus, measuring The myometrial thickness at 4 different sites9:
- The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan probe perpendicularly above the uterine fundus so that the entire curvature of the uterus was visualized. (d)The posterior wall: through using the maternal abdominal aortic pulsation as an anatomic marker.
At least 3 measurements were obtained at each site and averaged. The latency interval is determined in each of the 3 groups.
- Conditions
- Fetal Membranes, Premature Rupture
- Being tested
- Ultrasonographic examination
- Keywords
- myometrial thickness, Preterm premature rupture of membranes, Preterm Labour
- Medical subject headings
- Fetal Membranes, Premature Rupture, Preterm Premature Rupture of the Membranes, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic examinationDevice
Also called obtetrics ultrasound
An abdominal ultrasound for: Estimation of gestational age, biophysical profile (BPP), Detection of any fetal gross anomalies, Assessment of fetal growth measurement of the Amniotic Fluid Index (AFI), Detection of any abnormal placental insertion and/or uterine structural abnormalities as septate or bicornuate uterus, measuring The myometrial thickness at 4 different sites:
- The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan probe perpendicularly above the uterine fundus so that the entire curvature of the uterus is visualized. (d)The posterior wall: through using the maternal abdominal aortic pulsation as an anatomic marker.
| Study group | Role | What they receive |
|---|---|---|
| pPROM | 50 women with preterm premature rupture of membranes with gestational age from 24 to 34 weeks assessed by ultrasound examination Receives: Device: Ultrasonographic examination | |
| term non-labor control | 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks assessed by ultrasound examination Receives: Device: Ultrasonographic examination | |
| preterm non-labor control | 25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks assessed by ultrasound examination Receives: Device: Ultrasonographic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
latency interval as determined sonographic myometrial thickness
Measured: weeks in gestation
Secondary outcomes (2)
neonatal Apgar
Measured: 10 minutes after delivery
neonatal ICU admission
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study start1 Mar 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Membranes, Premature RuptureStudies of the same condition, open and under way.
- More trials run by Cairo 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380560
- Sponsor's protocol ID
- 129
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2015
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Assessment of Myometrial Thickness as a Predictor for the Latency Interval in Women With Preterm Premature Rupture of Membranes
- ClinicalTrials.gov ID
- NCT02380560
- Acronym / sponsor ID
- 129
- Conditions
- Fetal Membranes, Premature Rupture
- Keywords
- myometrial thickness, Preterm premature rupture of membranes, Preterm Labour
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 5 Mar 2015 (estimated)
- 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.
100 women divided into 3 groups:
- Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50) with gestational age from 24 to 34 weeks.
- Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks.
- Group III: included 25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks.The myometrial thickness at 4 different sites9:
- The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan probe perpendicularly above the uterine fundus so that the entire curvature of the uterus was visualized. (d)The posterior wall: through using the maternal abdominal aortic pulsation as an anatomic marker.
At least 3 measurements were obtained at each site and averaged. The latency interval is determined in each of the 3 groups.
Detailed description
The total number of pregnant women enrolled in the study was 100 women. These were divided into three groups:
- Group I: included 50 women with preterm premature rupture of membranes (PPROM, n=50) with gestational age from 24 to 34 weeks.
- Group II: included 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks.
- Group III: included 25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks.Full History taking, including personal history for maternal age, obstetric history for number of previous pregnancies, history of previous PPROM. History of present pregnancy included gestational age, history of drug intake with special emphasis to women with PPROM giving history of gush of clear watery fluid from the vagina. Past history to exclude women with a contra- indication for conservative management in the study group.
Physical examinations: General examination for pulse, arterial blood pressure and temperature to exclude any signs of chorioamnionitis in the study group.
Abdominally, fundal level examinations for predicting the gestational age and/or IUGR or abnormalities of liquor. Monitoring of uterine contraction to pick up women who are not in labor in the study group.
P/V examination was not done for the three groups. While definite diagnosis of PPROM relied on sterile speculum examination showing a collection of fluid in the vagina. Some women needed direct observation of the cervix during a valsulva maneuver or with cough to show free flow of fluid from the cervical os.
Ultrasonographic examination: An abdominal ultrasound for: Estimation of gestational age, Assessment of fetal well being by biophysical profile (BPP), Detection of any fetal gross anomalies, Assessment of fetal growth to exclude IUGR, Sonographic estimation of fetal weight (SEFW), measurement of the Amniotic Fluid Index (AFI), Detection of any abnormal placental insertion and/or uterine structural abnormalities as septate or bicornuate uterus, measuring The myometrial thickness at 4 different sites9:
- The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan probe perpendicularly above the uterine fundus so that the entire curvature of the uterus was visualized. (d)The posterior wall: through using the maternal abdominal aortic pulsation as an anatomic marker.
At least 3 measurements were obtained at each site and averaged. The latency interval is determined in each of the 3 groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pPROM | – | Device: Ultrasonographic examination50 women with preterm premature rupture of membranes with gestational age from 24 to 34 weeks assessed by ultrasound examination |
| term non-labor control | – | Device: Ultrasonographic examination25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks assessed by ultrasound examination |
| preterm non-labor control | – | Device: Ultrasonographic examination25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks assessed by ultrasound examination |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The total number of pregnant women will be enrolled in the study is 100 women. These wwill be divided into three groups: * Group I: includes 50 women with preterm premature rupture of membranes (PPROM, n=50) with gestational age from 24 to 34 weeks. * Group II: includes 25 term non-labor control (T-CTR, n=25) with gestational age from 37 to 41 weeks. * Group III: includes 25 preterm non-labor control (P-CTR, n=25) with gestational age from 24 to 34 weeks.
Key inclusion criteria (1 listed)
- singleton pregnancy with a definite history of current PPROM for the study group
Key exclusion criteria (9 listed)
- Suspected fetal growth restriction (IUGR),
- Any gross fetal anomalies,
- Abnormalities of placentation,
- Uterine structural abnormalities,
- Fetal jeopardy or intrauterine fetal death (IUFD).
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 |
|---|---|---|
| Ultrasonographic examinationAlso: obtetrics ultrasoundAn abdominal ultrasound for: Estimation of gestational age, biophysical profile (BPP), Detection of any fetal gross anomalies, Assessment of fetal growth measurement of the Amniotic Fluid Index (AFI), Detection of any abnormal placental insertion and/or uterine structural abnormalities as septate or bicornuate uterus, measuring The myometrial thickness at 4 different sites: a) The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan probe perpendicularly above the uterine fundus so that the entire curvature of the uterus is visualized. (d)The posterior wall: through using the maternal abdominal aortic pulsation as an anatomic marker. | Device | pPROM, preterm non-labor control, term non-labor control |
Primary outcome
latency interval as determined sonographic myometrial thickness
Time frame: weeks in gestation
2 secondary outcomes
neonatal Apgar
Time frame: 10 minutes after delivery
neonatal ICU admission
Time frame: 24 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
Related trials for Fetal Membranes, Premature Rupture
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Active, not recruitingPhase 3
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Premature Rupture of Membrane
RecruitingObservational study
Enhancing Prediction of Adverse Pregnancy Outcomes in Africa Through Partnerships and Innovation
Fetal Growth Restriction (FGR), Preterm Birth
Recruiting
Intravenous Papaverine for Term Prelabor Rupture of Membranes
Premature Rupture of Fetal Membranes
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.
Aly Abdelhafiz, MD contact
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
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 Fetal Membranes, Premature Rupture, run by Cairo 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
latency interval as determined sonographic myometrial thickness (time frame: weeks in 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 7 Mar 2018.