Myometrial Thickness as a Predictor for the Latency Interval in PPROM
Sonographic Assessment of Myometrial Thickness as a Predictor for the Latency Interval in Women With Preterm Premature Rupture of Membranes
1 other identifier
observational
100
1 country
1
Brief 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.
- 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: 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedMarch 7, 2018
March 1, 2018
11 months
February 26, 2015
March 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
latency interval as determined sonographic myometrial thickness
weeks in gestation
Secondary Outcomes (2)
neonatal Apgar
10 minutes after delivery
neonatal ICU admission
24 hours after delivery
Study Arms (3)
pPROM
50 women with preterm premature rupture of membranes with gestational age from 24 to 34 weeks assessed by ultrasound 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
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
Interventions
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: 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.
Eligibility Criteria
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.
You may qualify if:
- singleton pregnancy with a definite history of current PPROM for the study group
You may not qualify if:
- 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.
- Diabetics, immunocompromized and cardiac patients.
- Women with cervical cerclage.
- Women with drained liquor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alainy medical school
Cairo, 12151, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Maged, MD
Kasr Alainy medical school
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
February 26, 2015
First Posted
March 5, 2015
Study Start
March 1, 2018
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
March 7, 2018
Record last verified: 2018-03