Urea and Creatinine Level in Vaginal Fluid as a Predicato... | NCT03213535

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

NCT03213535

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Jul 12, 2017Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Rupture of Membranes; Premature

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Jul 10, 2017Estimated

Completion Date

Jul 10, 2017Estimated

First Submitted Date

Jul 8, 2017

First Submission Date that Met QC Criteria

Jul 8, 2017

First Posted Date

Jul 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2017

Last Update Posted Date

Jul 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

rasha medhat abdul-hady, principal Investigator Dr.rasha medhat abdul-hady, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Frequent uterine contractions more than 2 contractions in 10 minutes.
CTG showing frequent contractions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
delivery interval in Premature rupture of membranes	The time needed from the onset of PROM till time of onset of labour	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Maternal age between 20-35 years.
32-35 weeks gestational age.
Viable fetus.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
rasha M Medhat Abd El-Hady, MD	Contact	1224448449	0020	RASHAMEDHAT30@GMAIL.COM
Daniel O Anis, M.B., B.Ch.	Contact	1272755335	0020	dany.onsi@gmail.com

Overall Officials

Name	Affiliation	Role
rasha M Medhat Abd El-Hady, MD	Ain Shams University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams university	Recruiting	Cairo		+20	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16437525	Background	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.
27160546	Background	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.

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases