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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02380560
Other study ID # 129
Secondary ID
Status Recruiting
Phase N/A
First received February 26, 2015
Last updated March 6, 2018
Start date March 1, 2018
Est. completion date February 2019

Study information

Verified date March 2018
Source Cairo University
Contact Ahmed Maged, MD
Phone 01005227404
Email prof.ahmedmaged@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Kasr Alainy medical school Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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
See also
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Terminated NCT00290199 - Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture N/A
Recruiting NCT02369601 - PROMComplete for Determination of Rupture of Fetal Membranes
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Withdrawn NCT01063686 - The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester N/A
Not yet recruiting NCT00432588 - Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies Phase 1/Phase 2