Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02380560
Study type Observational
Source Cairo University
Contact Ahmed Maged, MD
Phone 01005227404
Email prof.ahmedmaged@gmail.com
Status Recruiting
Phase N/A
Start date March 1, 2018
Completion date February 2019

See also
  Status Clinical Trial Phase
Terminated NCT00201656 - Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM) Phase 4
Completed NCT02901795 - Early Detection of Chorioamnionitis in Preterm Premature Rupture of Membranes
Not yet recruiting NCT00247104 - The Use of Cranberries in Women With Preterm Premature Rupture of Membranes N/A
Not yet recruiting NCT06262308 - Emotional Support for Women Experiencing PPROM N/A
Completed NCT00070746 - Perinatal Infections in Pakistan N/A
Recruiting NCT02997345 - PPROM Registry (Preterm Premature Rupture of Membranes)
Terminated NCT00259519 - Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes N/A
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
Terminated NCT00890630 - Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term Phase 2
Not yet recruiting NCT00432588 - Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies Phase 1/Phase 2
Withdrawn NCT01063686 - The Cervical Cap in the Diagnosis of Rupture of Membranes in the Second Trimester N/A