Accomplishments of the GNPRH
In the ten years of its existence, the Network has developed an administrative structure, showed its ability to perform demographic and observational studies, and evaluate various types of diagnostic technologies. Below, four selected GNPRH initiatives are described. These initiatives have been identified as priority areas by the investigators and considered essential for the future development of intervention projects that have impact on the populations served by the GNPRH.
Assessment of Neonatal Mortality Rates and the Use of Effective Perinatal Clinical Practices
GNPRH sites were surveyed to assess birth-weight and gestational age specific neonatal mortality rates. Results indicate that sites use discrepant criteria for recording neonatal deaths with the most pronounced differences occurring between developed and developing centers.
Inconsistent neonatal death reporting has implications for across site evaluation of interventions designed to reduce neonatal mortality. Therefore, the GNPRH is working to implement consistent guidelines for accurate collection of neonatal death information and will use the web based information exchange system to be developed through this proposal, to achieve this goal. Incomplete and inconsistent data collection procedures also complicates accurate evaluation of factors contributing to the high perinatal mortality rates, and underscored the need for improvement in the area of data quality.
As part of this initiative, participating sites were also surveyed to assess the rate of use of various clinical interventions shown to reduce neonatal mortality. Results of this survey demonstrated that the use of perinatal clinical procedures also varied widely across sites.
For example, in developing countries the gestational age at which cesarean section is performed to enhance fetal survival (i.e.,not for maternal indications) ranges from 26 to 37 weeks (In developed countries the gestational age at which cesarean section is targeted at improving fetal outcomes is 24 weeks.) Only five out of nine centers used antibiotics to prolong latency of pregnancy after rupture of membranes, a practice shown to improve neonatal outcomes (Mercer BM, et al, JAMA, 1997). Most centers routinely used corticosteroids for preterm infants, and all centers employed repeat weekly steroid dosing if undelivered, a practice recently not recommended.
A manuscript has been published "Birthweight-Specific Neonatal Mortality in Developing Countries: Relation to Obstetric Practices", Int J Gyn & Obst 2003: 80(1) 71-78 (Publications, Straughn et al.)
Evaluation of the use of Peri-Operative
Antibiotic Prophylaxis During Cesarean Section
Endometritis and wound infection are common, potentially life-threatening complications of cesarean section (Cunningham FG, 1997). Evidence indicates that the use of antibiotic prophylaxis during cesarean section can reduce the rate of post c-section endometritis and wound infection (Smaill F, Hofmeyr GJ The Cochrane Library, 2001).
In collaboration with the International Hospital Infection Prevention and Quality Assessment Program at Children's Hospital and Harvard Medical School in Boston, GNPRH conducted a study to evaluate if antibiotic prophylaxis during cesarean section was being consistently practiced at member sites. Fifty consecutive cesarean sections performed in eight centers in five countries (The Philippines, Thailand, India, Myanmar and the United States) were surveyed. Data from each center were compared to a regimen recommended by the Cochrane Collaboration.
Results indicated large variations in the use of antibiotic prophylaxis across centers, and only four centers administered antibiotic prophylaxis to all women. Inappropriate multidrug regimens were used commonly. Only two centers reliably administered the antibiotic at the appropriate time. This study identified a significant opportunity for improvement in the care of women through enhancing the consistency of antibiotic use at all centers. A program to develop interventions specific to each center to improve this practice is being designed.
A manuscript has been published: "An International Survey of Practice Variation in the use of Antibiotic Prophylaxis in Cesarean Section"; Int J Gynecol Obstet; 73(2001) 141-45. (Publications, Huskins, et al.)
Case Management of Reproductive Tract Infections in India
Reproductive tract infections (RTI's) are among the most common reasons why adults seek health care in low-income countries, and hence they carry a large resource burden for both health systems and individual sufferers. Adequate management of these infections has been shown to significantly decrease the risk of HIV transmission and acquisition. Untreated or mismanaged RTI's carry serious long-term sequelae including chronic pain, ectopic pregnancy, male and female infertility, and adverse outcomes of pregnancy including fetal loss, and higher rates of neonatal morbidity and mortality.
Effective case management strategies for the most appropriate and effective management of the RTI's depends to a large degree on the local epidemiological profile (prevalence and aetiology) of the infections most commonly seen. In many cases, however, such an epidemiological picture may not have been outlined locally, and practitioners may instead use standardized procedures designed elsewhere, such as the use of syndromic management of RTI is as recommended by WHO. The appropriateness of such a response has not been validated to any large extent in India and other regions of the world.
This project aims to review existing guidelines for RTI management at one primary health center in India and to validate the effectiveness of existing guidelines from WHO and the National AIDS Control Organization (NACO) in terms of clinical management and costs. This will include evaluating the guidelines with respect to their levels of undertreatment and/or overtreatment of common infections. The results will be used to develop protocols for management which can be used in a variety of epidemiological and socio-cultural settings which may be expected to be found in India. In addition, in follow-up studies, we aim to incorporate an evaluation of rapid diagnostic tests for the most common sexually transmitted infections. (Publications, Mittal et al.)
Evaluation of the FemExam Test Card® compared to gram staining and clinical criteria for diagnosis of Bacterial Vaginosis among Female Sex Workers (FSW) in Bangladesh
The purpose of this study was to determine the sensitivity and specificity, positive predictive and negative predictive values of the FemExam Test card® a rapid diagnostic tests for BV and clinical criteria as described by Amsel, compared to Gram staining of vaginal secretions using Nugent’s scoring for the diagnosis of BV in asymptomatic and symptomatic FSWs.
A fast, easy to use and cost effective diagnostic method would be a valuable tool for diagnosis of BV in settings where skilled manpower and infrastructure is not available. A number of new rapid diagnostic tests for BV have been developed in recent years. The FemExam Test card® has been developed and it is based on the detection of pH and proline iminopeptidase (PIP) activity (Quidel Corp., San Diego, CA, USA and Cooper surgical, Shelton, CT, USA). The first generation of this rapid test has been evaluated in women from the general population with and without symptoms of vaginal discharge, however it has not been evaluated among women with high risk factors for STIs, vaginitis and acquisition of HIV.
A total of 222 FSWs (100 symptomatic and 122 asymptomatic) were evaluated. High vaginal swab, an endocervical swab, and blood samples from enrolled subjects were obtained for diagnosis of BV, Neisseria gonorrhoeae, Chlamydiatrachomatis, Trichomonas vaginalis and syphilis. The prevalence of BV according to Amsel’s criteria was 61.3% (136/222); Nugent’s scoring was 68% (151/222) and by the FemExam Testcard® it was 51.8% (115/222). The prevalence of N. gonorrhoeae, C. trachomatis, syphilis and Trichomonas vaginalis was 25.7% (57/222), 19.8% (44/222), 21.2% (47/222) and 23.9% (53/222) respectively. The sensitivity and specificity of Amsel’s criteria and the FemExam Test card® compared to the gold standard was 88% and 96% and 70% and 86% respectively. There was no significant difference in sensitivity and specificity of Amsel’s criteria and the FemExam Testcard® compared to the gold standard in the diagnosis of asymptomatic BV.
This work provided additional experience to investigators of the GNPRH in evaluation of rapid diagnostic tests for RTI’s. This project demonstrated the value of a recently established collaboration between the GNPRH and the International Centre for Diarrhoeal Disease Research, Bangladesh in Dhaka. It is anticipated that in addition to a publication of this work in an international peer-reviewed journal, in which the first author is a junior faculty member at ICDDR, B, other research projects will be developed in the next three to five years. Specifically, a proposal to develop a RCT to test the effectiveness of chlorhexidine washings of the vagina during labor and of the neonate immediately after birth, to reduce neonatal and maternal morbidity and mortality has been prepared and is being considered by USAID for funding. (Publications, Mittal et al.)
Reproductive Health Defined
We accept the definition of Reproductive Health as outlined by the World Health Organization:
'Within the framework of WHO's definition of health as a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity, reproductive health addresses the reproductive processes, functions and systems at all stages of life.
Reproductive health, therefore, implies that people are able to have a responsible, satisfying and safe sex life and that they have the capability to reproduce and the freedom to decide, if, when, and how often to do so.
Implicit in this last condition are the right of men and women to be informed of, and to have access to, safe, effective, affordable and acceptable methods of fertility regulation of their choice, and the right of access to appropriate healthcare services that will enable women to go safely through pregnancy and childbirth and provide couples with the best chance of having a healthy infant.'
Our network is poised to accept the challenge posed by the World Health Organization to rapidly develop innovative interventions that are sustainable in resource-poor countries. Over time, we envision that these activities will become the sustainable core activities of the GNPRH, through additional grant funding from international agencies such as the WHO, UN, NIH, CDC, and through national and local in-country funding mechanisms.