Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-03-01 @ 3:54 PM
Study NCT ID:
NCT03213535
Status:
UNKNOWN
Last Update Posted:
2017-07-12
First Post:
2017-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: