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Maternal and Perinatal Outcome in Women With History of Premature Labor in Previous Pregnancy

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ClinicalTrials.gov Identifier: NCT01375439
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Danielle Cristina Alves Feitosa Gondo, UPECLIN HC FM Botucatu Unesp

March 23, 2011
June 17, 2011
June 23, 2015
August 2011
December 2012   (Final data collection date for primary outcome measure)
Track pregnant women priority for the exams that allow the etiologic diagnosis of lower genital tract infections. [ Time Frame: Up to 6 months after birth ]
This study starts from the assumption that the active search and etiologic treatment of genital infections can reduce adverse pregnancy outcome and, if confirmed, could subsidize health managers in the implementation of actions aimed at introducing, in the health services of varying degrees of complexity , the etiologic diagnosis of lower genital tract infections. It is known that the costs of such a diagnosis are high and could have prevented the routine examination of patients during prenatal care.
Same as current
Complete list of historical versions of study NCT01375439 on ClinicalTrials.gov Archive Site
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Not Provided
Not Provided
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Maternal and Perinatal Outcome in Women With History of Premature Labor in Previous Pregnancy
Maternal and Perinatal Outcome in Women With History of Premature Labor in Previous Pregnancy and Submitted to Active Search of Genital Infection
Introduction: Preterm labor (PTL) is an important obstetric intercurrence that affects 5 to 10% of pregnancies. Among the known factors of PTL etiology are PTL occurrence in previous pregnancies, multiple pregnancies, polyhydramnios, vaginal bleeding during pregnancy, premature membrane rupture (PMR) and bacterial vaginosis. Despite the advancement achieved in Neonatology, morbidity and mortality resulting from high rates of preterm births have remained constant in the last few decades. Objective: This study aims at evaluating maternal and perinatal outcomes of pregnant women with a history of preterm labor in previous pregnancies and submitted to active search for vaginal infection. Material and Method: It is a prospective-cohort epidemiological study to be conducted in Botucatu/SP. Two study groups (G1 and G2) will be formed, and each of them will comprise 140 pregnant women with a history of preterm childbirth. G1 will be related to the active search and etiological diagnosis of lower genital tract infections, and G2 will be related to non-search for such infections, for which the routine care protocol of primary health units in the city of Botucatu will be maintained. Care propedeutics for the pregnant women (G1) will include the performance of direct examination of vaginal content stained by the Gram method, culture in Diamonds medium, polymerase chain reaction (PCR) of endocervical secretion collected in the primary health care services in the city at two moments: prior to the 20th gestational week (M1) and at the 36th week (M2). Moment M3 will take place after childbirth for evaluation of the perinatal outcome.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Pregnancy
  • Vulvovaginitis
  • Uterine Cervicitis
  • Pregnancy Outcome
Other: Active search of lower genital tract infections
Two groups (G1 and G2) will be part of study, each one composed of 140 pregnant women with a history of premature birth, G1 will have the active search and etiologic diagnosis of lower genital tract infections and G2 do not search of these infections, keeping for this group, the protocol of routine care of basic health units in the city of Botucatu. Workup care of pregnant women (G1) will include the completion of direct examination of vaginal contents stained by Gram's method, culture in the medium of Diamonds and polymerase chain reaction (PCR) of endocervical secretions, collected by health services in primary care the municipality in two moments: before 20th pregnancy week (M1) and in 36th pregnancy week (M2). The moment M3 will be after the birth, to evaluate the perinatal outcome.
Active search of lower genital tract infections

Active search of lower genital tract infections

Two groups (G1 and G2) will be part of study, each one composed of 140 pregnant women with a history of premature birth, G1 will have the active search and etiologic diagnosis of lower genital tract infections and G2 do not search of these infections, keeping for this group, the protocol of routine care of basic health units in the city of Botucatu. Workup care of pregnant women (G1) will include the completion of direct examination of vaginal contents stained by Gram's method, culture in the medium of Diamonds and polymerase chain reaction (PCR) of endocervical secretions, collected by health services in primary care the municipality in two moments: before 20th pregnancy week (M1) and in 36th pregnancy week (M2). The moment M3 will be after the birth, to evaluate the perinatal outcome.

Intervention: Other: Active search of lower genital tract infections
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
Same as current
May 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Will be included in the study women with a history of preterm labor in previous pregnancy, without other risk factors identified in the initial prenatal current to initiate prenatal care until 20 weeks of gestation in any unit of primary care and Botucatu they have agreed to participate.

Exclusion Criteria:

  • Will be excluded from the study women who have complications during pregnancy such as urinary tract infections, severe periodontal disease, hypertension, diabetes or multiple gestation, among others.
Sexes Eligible for Study: Female
Child, Adult, Older Adult
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01375439
ddt1333
No
Not Provided
Not Provided
Danielle Cristina Alves Feitosa Gondo, UPECLIN HC FM Botucatu Unesp
UPECLIN HC FM Botucatu Unesp
Not Provided
Not Provided
UPECLIN HC FM Botucatu Unesp
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP