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

A

Ain Shams University

Status

Unknown

Conditions

Rupture of Membranes; Premature

Study type

Observational

Funder types

Other

Identifiers

NCT03213535
PRP-PROM

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

rasha M Medhat Abd El-Hady, MD; Daniel O Anis, M.B., B.Ch.

Data sourced from clinicaltrials.gov

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