- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380560
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Aly Abdelhafiz, MD
- Email: drali1998@yahoo.com
Study Locations
-
-
-
Cairo, Egypt, 12151
- Recruiting
- Kasr Alainy medical school
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
pPROM
50 women with preterm premature rupture of membranes with gestational age from 24 to 34 weeks assessed by ultrasound examination
|
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.
Other Names:
|
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
|
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.
Other Names:
|
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
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
latency interval as determined sonographic myometrial thickness
Time Frame: weeks in gestation
|
weeks in gestation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
neonatal Apgar
Time Frame: 10 minutes after delivery
|
10 minutes after delivery
|
neonatal ICU admission
Time Frame: 24 hours after delivery
|
24 hours after delivery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 129
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fetal Membranes, Premature Rupture
-
Shaare Zedek Medical CenterUnknownPremature Rupture of Fetal Membranes
-
University Hospital, Clermont-FerrandBiosynex CompanyRecruitingPremature Rupture of MembraneFrance
-
Ain Shams UniversityUnknownRupture of Membranes; PrematureEgypt
-
Common SenseUnknown
-
Regional Obstetrical ConsultantsTerminatedPreterm Premature Rupture of MembranesUnited States
-
Ain Shams Maternity HospitalAin Shams UniversityUnknownPreterm Premature Rupture of MembranesEgypt
-
Cook Group IncorporatedCompleted
-
Hillel Yaffe Medical CenterUnknownPremature Rupture of Fetal MembranesIsrael
-
Nilratan Sircar Medical CollegeCompletedPremature Rupture of Membranes at TermIndia
-
Ain Shams Maternity HospitalUnknownPreterm Premature Rupture of Membranes
Clinical Trials on Ultrasonographic examination
-
Siirt UniversityCompletedPregnancy Complications | Maternal-Fetal Relations | Perinatal ProblemsTurkey
-
Chang Gung Memorial HospitalCompletedCongenital Muscular Torticollis
-
Samsung Medical CenterCompletedShoulder Arthroscopic SurgeryKorea, Republic of
-
Near East University, TurkeyCompletedPostpartum Hemorrhage | Bilateral Iliac Artery LigationTurkey
-
University Hospital, Basel, SwitzerlandUniversity Children's Hospital BaselUnknownNormal Values of Peripheral Nerves in Healthy ChildrenSwitzerland
-
Odense University HospitalUniversity of Southern DenmarkUnknownChest Pain | Acute Respiratory Failure
-
University of Warmia and MazuryUnknownFractures, Bone | Upper Extremity Injury | Vascularization | Healing Fracture of BonePoland
-
University of Campania "Luigi Vanvitelli"CompletedDysmenorrhea | Myoma | Uterine Bleeding, Dysfunctional | Uterine Bleeding Heavy | Endometrium HyperplasiaItaly
-
Ain Shams UniversityNot yet recruitingEffect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in NeonatesRespiratory Tract Diseases | Cerebral Blood Flow | Infant, Premature, DiseasesEgypt