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Myometrial Thickness as a Predictor for the Latency Interval in PPROM

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ClinicalTrials.gov Identifier: NCT02380560
Recruitment Status : Unknown
Verified March 2018 by Ahmed Maged, Cairo University.
Recruitment status was:  Recruiting
First Posted : March 5, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

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.


Condition or disease Intervention/treatment
Fetal Membranes, Premature Rupture Device: Ultrasonographic examination

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sonographic Assessment of Myometrial Thickness as a Predictor for the Latency Interval in Women With Preterm Premature Rupture of Membranes
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

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
Device: Ultrasonographic 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 Name: obtetrics ultrasound

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
Device: Ultrasonographic 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 Name: obtetrics ultrasound

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
Device: Ultrasonographic 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 Name: obtetrics ultrasound




Primary Outcome Measures :
  1. latency interval as determined sonographic myometrial thickness [ Time Frame: weeks in gestation ]

Secondary Outcome Measures :
  1. neonatal Apgar [ Time Frame: 10 minutes after delivery ]
  2. neonatal ICU admission [ Time Frame: 24 hours after delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380560


Contacts
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Contact: Ahmed Maged, MD 01005227404 prof.ahmedmaged@gmail.com
Contact: Aly Abdelhafiz, MD drali1998@yahoo.com

Locations
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Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12151
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Kasr Alainy medical school
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Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02380560    
Other Study ID Numbers: 129
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Keywords provided by Ahmed Maged, Cairo University:
myometrial thickness
Preterm premature rupture of membranes
Preterm Labour
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries