Myometrial Thickness as a Predictor for the Latency Interval in PPROM

NCT ID: NCT02380560

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-02-28

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.

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.

Conditions

Fetal Membranes, Premature Rupture

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

pPROM

50 women with preterm premature rupture of membranes with gestational age from 24 to 34 weeks assessed by ultrasound examination

Ultrasonographic examination

Intervention Type: DEVICE

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.

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

Ultrasonographic examination

Intervention Type: DEVICE

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.

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

Ultrasonographic examination

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

obtetrics ultrasound

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maged

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

Kasr Alainy medical school

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Maged, MD

Role: CONTACT

prof.ahmedmaged@gmail.com

01005227404

Aly Abdelhafiz, MD

Role: CONTACT

drali1998@yahoo.com

Facility Contacts

Ahmed Maged, MD

Role: primary

prof.ahmedmaged@gmail.com

01005227404

Other Identifiers

129

Identifier Type: -

Identifier Source: org_study_id