Fetal Membranes, Premature Rupture Clinical Trial
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:
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | February 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - singleton pregnancy with a definite history of current PPROM for the study group Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Kasr Alainy medical school | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | latency interval as determined sonographic myometrial thickness | weeks in gestation | ||
Secondary | neonatal Apgar | 10 minutes after delivery | ||
Secondary | neonatal ICU admission | 24 hours after delivery |
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