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

Rupture of Membranes; Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03213535
• Other study ID #: PRP-PROM
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2017
• Last updated: July 10, 2017
• Start date: January 2017
• Est. completion date: July 10, 2017

Study information

• Verified date: January 2017
• Source: Ain Shams University
• Contact: rasha M Medhat Abd El-Hady, MD
• Phone: 1224448449
• Email: RASHAMEDHAT30[@]GMAIL.COM
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Rupture
• Rupture of Membranes; Premature

Locations

Country	Name	City	State
Egypt	Ain Shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

Dare MR, Middleton P, Crowther CA, Flenady VJ, Varatharaju B. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005302. Review. Update in: Cochrane Database Syst Rev. 2017 Jan 04;1:CD005302. — View Citation

Gezer C, Ekin A, Golbasi C, Kocahakimoglu C, Bozkurt U, Dogan A, Solmaz U, Golbasi H, Taner CE. Use of urea and creatinine levels in vaginal fluid for the diagnosis of preterm premature rupture of membranes and delivery interval after membrane rupture. J Matern Fetal Neonatal Med. 2017 Apr;30(7):772-778. doi: 10.1080/14767058.2016.1188072. Epub 2016 May 26. — View Citation

Kafali H, Oksüzler C. Vaginal fluid urea and creatinine in diagnosis of premature rupture of membranes. Arch Gynecol Obstet. 2007 Mar;275(3):157-60. Epub 2006 Sep 12. — View Citation

Kim YH, Park YW, Kwon HS, Kwon JY, Kim BJ. Vaginal fluid beta-human chorionic gonadotropin level in the diagnosis of premature rupture of membranes. Acta Obstet Gynecol Scand. 2005 Aug;84(8):802-5. — View Citation

Melamed N, Hadar E, Ben-Haroush A, Kaplan B, Yogev Y. Factors affecting the duration of the latency period in preterm premature rupture of membranes. J Matern Fetal Neonatal Med. 2009 Nov;22(11):1051-6. doi: 10.3109/14767050903019650. — View Citation

Ngwenya S, Lindow SW. 24 hour rhythm in the timing of pre-labour spontaneous rupture of membranes at term. Eur J Obstet Gynecol Reprod Biol. 2004 Feb 10;112(2):151-3. — View Citation

Oliveira FR, Barros EG, Magalhães JA. Biochemical profile of amniotic fluid for the assessment of fetal and renal development. Braz J Med Biol Res. 2002 Feb;35(2):215-22. — View Citation

Pintucci A, Meregalli V, Colombo P, Fiorilli A. Premature rupture of membranes at term in low risk women: how long should we wait in the "latent phase"? J Perinat Med. 2014 Mar;42(2):189-96. doi: 10.1515/jpm-2013-0017. — View Citation

Ramsey PS, Lieman JM, Brumfield CG, Carlo W. Chorioamnionitis increases neonatal morbidity in pregnancies complicated by preterm premature rupture of membranes. Am J Obstet Gynecol. 2005 Apr;192(4):1162-6. — View Citation

Ramsey PS, Nuthalapaty FS, Lu G, Ramin S, Nuthalapaty ES, Ramin KD. Contemporary management of preterm premature rupture of membranes (PPROM): a survey of maternal-fetal medicine providers. Am J Obstet Gynecol. 2004 Oct;191(4):1497-502. — View Citation

Tigga M.P. and Malik S. Comparative analysis of four biomarkers in diagnosing premature rupture of membranes and their correlation with onset of labour: Int J Reprod Contracept Obstet Gynecol. 2015 Aug;4(4):1070-1075

Tydén O, Eriksson U, Agren H, Berne C. Estimation of fetal maturity by amniotic fluid cytology, creatinine, lecithin/sphingomyelin ratio and phosphatidylglycerol. Gynecol Obstet Invest. 1983;16(6):317-26. — View Citation

van der Ham DP, Vijgen SM, Nijhuis JG, van Beek JJ, Opmeer BC, Mulder AL, Moonen R, Groenewout M, van Pampus MG, Mantel GD, Bloemenkamp KW, van Wijngaarden WJ, Sikkema M, Haak MC, Pernet PJ, Porath M, Molkenboer JF, Kuppens S, Kwee A, Kars ME, Woiski M, Weinans MJ, Wildschut HI, Akerboom BM, Mol BW, Willekes C; PPROMEXIL trial group. Induction of labor versus expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks: a randomized controlled trial. PLoS Med. 2012;9(4):e1001208. doi: 10.1371/journal.pmed.1001208. Epub 2012 Apr 24. — View Citation

Zuo Y, Wang C, Zhou J, Sachdeva A, Ruelos VC. Simultaneous determination of creatinine and uric acid in human urine by high-performance liquid chromatography. Anal Sci. 2008 Dec;24(12):1589-92. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delivery interval in Premature rupture of membranes	The time needed from the onset of PROM till time of onset of labour	48 hours