Rupture of Membranes; PrematureNCT03213535
Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture
An observational study of Rupture of Membranes; Premature, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rupture of Membranes; Premature
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to 10 Jul 2017
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Maternal age between 20-35 years.
- 32-35 weeks gestational age.
- Viable fetus.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams university
Cairo, +20
rasha m medhat abd el hady, MD, 1224448449 ext. 002, RASHAMEDHAT30@GMAIL.COM
About this study
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.
Read the 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:
- Frequent uterine contractions more than 2 contractions in 10 minutes.
- CTG showing frequent contractions.
- Conditions
- Rupture of Membranes; Premature
- Keywords
- PROM
- Medical subject headings
- Fetal Membranes, Premature Rupture
What is being measured
The primary outcome is the main question the study is designed to answer.
delivery interval in Premature rupture of membranes
The time needed from the onset of PROM till time of onset of labour
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJan 2017
- Primary completion10 Jul 2017 (estimated)
- Study completion10 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Rupture of Membranes; PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rasha medhat abdul-hady, Ain Shams University
- Investigators
- rasha M Medhat Abd El-Hady, MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213535
- Sponsor's protocol ID
- PRP-PROM
- Status last verified
- Jan 2017
- First submitted
- 8 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16437525Gezer 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.
PubMed 27160546Kafali 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.
PubMed 16967274Kim 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.
PubMed 16026409Melamed 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.
PubMed 19900043Ngwenya 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.
PubMed 14746949Oliveira 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.
PubMed 11847525Ramsey 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.
PubMed 15846196Pintucci 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.
PubMed 24259235Ramsey 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.
PubMed 15507990Tigga 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
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.
PubMed 6654186van 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.
PubMed 22545024Zuo 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.
PubMed 19075469
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urea and Creatinine Level in Vaginal Fluid as a Predicator for Length of Latency Period in Prelabour Membranes Rupture
- ClinicalTrials.gov ID
- NCT03213535
- Acronym / sponsor ID
- PRP-PROM
- Conditions
- Rupture of Membranes; Premature
- Keywords
- PROM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 10 Jul 2017 (estimated)
- Study completion
- 10 Jul 2017 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Frequent uterine contractions more than 2 contractions in 10 minutes.
- CTG showing frequent contractions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Maternal age between 20-35 years.
- 32-35 weeks gestational age.
- Viable fetus.
Key exclusion criteria (7 listed)
- Vaginal bleeding either spontaneous or traumatic e.g. placenta previa.
- Chorioamnionitis.
- Multiple pregnancy.
- Presence of uterine contractions.
- Amniotic fluid disorders e.g. polyhydramnios
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Background: PubMed 16437525Dare 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.
- Background: PubMed 27160546Gezer 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.
- Background: PubMed 16967274Kafali 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.
- Background: PubMed 16026409Kim 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.
- Background: PubMed 19900043Melamed 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.
- Background: PubMed 14746949Ngwenya 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.
- Background: PubMed 11847525Oliveira 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.
- Background: PubMed 15846196Ramsey 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.
- Background: PubMed 24259235Pintucci 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.
- Background: PubMed 15507990Ramsey 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.
- BackgroundTigga 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: PubMed 6654186Tyden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rasha M Medhat Abd El-Hady, MD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rupture of Membranes; Premature, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rasha M Medhat Abd El-Hady, MD (1224448449 ext. 0020, RASHAMEDHAT30@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delivery interval in Premature rupture of membranes (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03213535, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017; AzTrials last refreshed its copy on 30 Oct 2026.