NCT03213535

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
Last Updated

July 12, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

July 8, 2017

Last Update Submit

July 10, 2017

Conditions

Rupture of Membranes; Premature

Keywords

PROM

Outcome Measures

Primary Outcomes (1)

  • delivery interval in Premature rupture of membranes

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

    48 hours

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams university

Cairo, +20, Egypt

RECRUITING

Related 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. doi: 10.1002/14651858.CD005302.pub2.

    PMID: 16437525BACKGROUND

  • 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.

    PMID: 27160546BACKGROUND

  • Kafali H, Oksuzler C. Vaginal fluid urea and creatinine in diagnosis of premature rupture of membranes. Arch Gynecol Obstet. 2007 Mar;275(3):157-60. doi: 10.1007/s00404-006-0240-1. Epub 2006 Sep 12.

    PMID: 16967274BACKGROUND

  • 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. doi: 10.1111/j.0001-6349.2005.00712.x.

    PMID: 16026409BACKGROUND

  • 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.

    PMID: 19900043BACKGROUND

  • 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. doi: 10.1016/s0301-2115(03)00286-0.

    PMID: 14746949BACKGROUND

  • Oliveira FR, Barros EG, Magalhaes 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. doi: 10.1590/s0100-879x2002000200010.

    PMID: 11847525BACKGROUND

  • 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. doi: 10.1016/j.ajog.2004.11.035.

    PMID: 15846196BACKGROUND

  • 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.

    PMID: 24259235BACKGROUND

  • 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. doi: 10.1016/j.ajog.2004.08.005.

    PMID: 15507990BACKGROUND

  • 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

    BACKGROUND

  • Tyden 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. doi: 10.1159/000299289.

    PMID: 6654186BACKGROUND

  • 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.

    PMID: 22545024BACKGROUND

  • 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. doi: 10.2116/analsci.24.1589.

    PMID: 19075469BACKGROUND

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • rasha M Medhat Abd El-Hady, MD

    Ain Shams University

    STUDY DIRECTOR

Central Study Contacts

rasha M Medhat Abd El-Hady, MD

CONTACT

1224448449RASHAMEDHAT30@GMAIL.COM

Daniel O Anis, M.B., B.Ch.

CONTACT

1272755335dany.onsi@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator Dr.rasha medhat abdul-hady

Study Record Dates

First Submitted

July 8, 2017

First Posted

July 11, 2017

Study Start

January 1, 2017

Primary Completion

July 10, 2017

Study Completion

July 10, 2017

Last Updated

July 12, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)