Clinical trial NCT03213535: Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture
Official title: Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rupture of Membranes; Premature
Keywords: PROM
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: sixity pregnant women with PROM with singleton pregnancies with a gestational age between 32- 35 gestational weeks by reliable menstrual history and confirmed by pelvi-abdominal ultrasound.

Membranes rupture will be diagnosed by the direct visualization of fluid leakage from the cervical canal using sterile speculum.

Brief summary: This study aims to investigate the relation between the concentration of urea and creatinine in vaginal fluid and length of latency period in women with PROM between 32 and 35 weeks gestation.

Detailed description: 60 pregnant women with PROM with singleton pregnancies with a gestational age between 32- 35 gestational weeks History taking followed by examination All women will be put in dorsal lithotomy position, using a proper light source and sterile gloves; sterile speculum free of gel will be placed into vagina.

For every woman a specimen of vaginal fluid will be taken as follows: 5 ml of sterile saline solution will be injected into the posterior vaginal fornix taken after aspiration of 3ml with the same syringe.

All samples will be obtained within 6 hours after membranes rupture before vaginal examination and the administration of any drugs. Upon collection, samples were centrifuged at 3000 rpm for 10 minutes and supernatant fluid was separated. Exact concentrations of urea and creatinine will be measured

All women will be put under observation for 48 hours and time of onset of delivery will be documented, the onset of labor will be diagnosed by either:

1. Frequent uterine contractions more than 2 contractions in 10 minutes.
2. CTG showing frequent contractions.

Eligibility criteria: Inclusion Criteria:

1. Maternal age between 20-35 years.
2. 32-35 weeks gestational age.
3. Viable fetus.

Exclusion Criteria:

1. Vaginal bleeding either spontaneous or traumatic e.g. placenta previa.
2. Chorioamnionitis.
3. Multiple pregnancy.
4. Presence of uterine contractions.
5. Amniotic fluid disorders e.g. polyhydramnios
6. Meconium stained amniotic fluid prior to active phase of labor.
7. Maternal disease necessitating termination of pregnancy e.g. severe preeclampsia

Primary outcomes:
measure: delivery interval in Premature rupture of membranes
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
affiliation: Ain Shams University
name: rasha M Medhat Abd El-Hady, MD
role: STUDY_DIRECTOR
References:
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