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

Primary Purpose

Pregnancy, Vulvovaginitis, Uterine Cervicitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active search of lower genital tract infections
Sponsored by
UPECLIN HC FM Botucatu Unesp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Pregnancy, vulvovaginitis, uterine cervicitis, pregnancy outcome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Active search of lower genital tract infections

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Track pregnant women priority for the exams that allow the etiologic diagnosis of lower genital tract infections.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2011
    Last Updated
    June 19, 2015
    Sponsor
    UPECLIN HC FM Botucatu Unesp
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01375439
    Brief Title
    Maternal and Perinatal Outcome in Women With History of Premature Labor in Previous Pregnancy
    Official Title
    Maternal and Perinatal Outcome in Women With History of Premature Labor in Previous Pregnancy and Submitted to Active Search of Genital Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    UPECLIN HC FM Botucatu Unesp

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy, Vulvovaginitis, Uterine Cervicitis, Pregnancy Outcome
    Keywords
    Pregnancy, vulvovaginitis, uterine cervicitis, pregnancy outcome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    280 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active search of lower genital tract infections
    Arm Type
    Other
    Arm Description
    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 Type
    Other
    Intervention Name(s)
    Active search of lower genital tract infections
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Track pregnant women priority for the exams that allow the etiologic diagnosis of lower genital tract infections.
    Description
    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.
    Time Frame
    Up to 6 months after birth

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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