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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01375439
First received: March 23, 2011
Last updated: July 4, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Pregnancy
Vulvovaginitis
Uterine Cervicitis
Pregnancy Outcome
Other: Active search of lower genital tract infections

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Maternal and Perinatal Outcome in Women With History of Premature Labor in Previous Pregnancy and Submitted to Active Search of Genital Infection

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 280
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Danielle Cristina Alves Feitosa Gondo, Department of Public Health - São Paulo State University "Júlio de Mesquita Filho"
ClinicalTrials.gov Identifier: NCT01375439     History of Changes
Other Study ID Numbers: ddt1333
Study First Received: March 23, 2011
Last Updated: July 4, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Pregnancy
vulvovaginitis
uterine cervicitis
pregnancy outcome

Additional relevant MeSH terms:
Pregnancy Complications
Obstetric Labor, Premature
Uterine Cervicitis
Vulvovaginitis
Genital Diseases, Female
Obstetric Labor Complications
Uterine Cervical Diseases
Uterine Diseases
Vaginal Diseases
Vaginitis
Vulvar Diseases
Vulvitis

ClinicalTrials.gov processed this record on October 22, 2014