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Clinical Trials/NCT03213535
NCT03213535UnknownNot Applicable

Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture

Ain Shams University1 site in 1 country60 target enrollmentStarted: January 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
delivery interval in Premature rupture of membranes

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Maternal age between 20-35 years.
  • 32-35 weeks gestational age.
  • Viable fetus.

Exclusion Criteria

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

Outcomes

Primary Outcomes

delivery interval in Premature rupture of membranes

Time Frame: 48 hours

The time needed from the onset of PROM till time of onset of labour

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

rasha medhat abdul-hady

principal Investigator Dr.rasha medhat abdul-hady

Ain Shams University

Study Sites (1)

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