Clinical Trial: Myometrial Thickness as a Predictor for the Latency Interval in PPROM

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Sonographic Assessment of Myometrial Thickness as a Predictor for the Latency Interval in Women With Preterm Premature Rupture of Membranes

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 Summary:

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 ultras
Sponsor: Cairo University

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • neonatal Apgar [ Time Frame: 10 minutes after delivery ]
  • neonatal ICU admission [ Time Frame: 24 hours after delivery ]


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: February 26, 2015
Date Started: March 2015
Date Completion: February 2016
Last Updated: March 2, 2015
Last Verified: March 2015