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

• Conditions: Rupture of Membranes; Premature

• Registration Number: NCT03213535
• Lead Sponsor: Ain Shams University

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 Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-08
• Primary Completion: 2017-07-10
• Study Completion: 2017-07-10
• Last Update Submitted: 2017-07-10
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
delivery interval in Premature rupture of membranes	48 hours	The time needed from the onset of PROM till time of onset of labour

Trial Locations

Locations (1)

Ain Shams university; 🇪🇬 Cairo, Egypt