Bacterial VaginosisNCT00070746
Perinatal Infections in Pakistan
An observational study of Bacterial Vaginosis and Fetal Membranes, Premature Rupture, run by NICHD Global Network for Women's and Children's Health at 1 site in Pakistan.
Trial summary
There are large differences in health outcomes related to pregnancy and birth between developed and developing countries. This study will investigate how infections, medical history, health care behavior and psychosocial issues are associated with pregnancy outcomes in Pakistan. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis, Fetal Membranes, Premature Rupture, Chorioamnionitis
- How many people
- 1,500 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2003to Jul 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants must
- be in their 20th to 26th week of pregnancy (to be confirmed by an ultrasound)
- be permanent residents (resident for the past months or intending to stay for next the 6 months) of the study site in Hyderabad, Pakistan; and,
- give informed (written or verbal) consent.
Who cannot join
- have clinical diagnoses of life-threatening conditions (requiring immediate treatment or hospitalization, as diagnosed by the attending physician).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perinatal Infections and Pregnancy Outcomes in Pakistan: A Collaborative Research Project in Partnership With the University of Alabama, USA
There are large differences in health outcomes related to pregnancy and birth between developed and developing countries. This study will investigate how infections, medical history, health care behavior and psychosocial issues are associated with pregnancy outcomes in Pakistan.
Read the detailed description
Pakistan, the world's seventh most populous country of about 138 million people, is beset with severe problems in its maternal and child health sector. The official maternal mortality ratio for Pakistan is reported as 340 per 100,000 live births.
The overall goal to conduct a prospective observational study to identify the risk factors for adverse pregnancy outcomes including reproductive tract infections such as BV, and other physical, dental, nutritional, psychosocial, and behavioral characteristics. The primary objective is to examine the association between BV in pregnant women at 20-26 weeks gestation and various other biochemical infection markers with adverse pregnancy outcomes (i.e., perinatal mortality [PNM], neonatal mortality, low birth weight [LBW], spontaneous preterm delivery [SPTD], premature rupture of membranes [PROM], histological chorioamnionitis).
Additionally, this study will explore the relationship of various health behaviors and health status to the presence of perinatal infections. A total of 1,500 pregnant women will be enrolled in the study. A matched case-control study will be conducted at the end of the data collection period to evaluate the use of markers for the prediction of infection related perinatal mortality and infection related SPTD. All investigators and laboratory personnel will remain blinded to the identity of specimens through the use of unique study identifier numbers. Collected data will then be unblinded, analysed, and correlated with the previously collected demographic, obstetrics, and neonatal outcome, microbiology and histopathological data.
Based on the findings of this study, appropriate interventions to address reproductive tract infection (RTI) could be developed and field-tested in Pakistan. We expect that these interventions, once successfully field-tested, could be widely used to improve maternal and child survival in Pakistan and other developing countries. Given the critical state of maternal and child health in Pakistan, and considering the emerging evidence that infections could lead to poor pregnancy outcomes, this study is extremely relevant and timely, and it has the potential to contribute significantly toward the improvement of reproductive health in Pakistan. Primary outcome is perinatal mortality. Secondary outcomes include birth weight; spontaneous delivery occurring before 37 weeks gestation; rupture of fetal membranes before 37 weeks of gestation; and maternal death. The sample size was based on 25% prevalence of BV in the control group; 10 percent dropout rate; 80 percent power; and a two-tailed type I error of 0.05.
- Keywords
- Perinatal mortality [PNM], Neonatal mortality, Low birth weight [LBW], Spontaneous preterm delivery [SPTD], Premature rupture of membranes [PROM], Histological chorioamnionitis, Global Network, Pakistan, Maternal and child health, International, Women's health
- Medical subject headings
- Vaginosis, Bacterial, Fetal Membranes, Premature Rupture, Chorioamnionitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2003 (estimated)
- Study startJun 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Alabama at Birmingham, Aga Khan University
- Responsible party
- Sponsor
- Investigators
- Robert Goldenberg, MD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070746
- Sponsor's protocol ID
- GN 09
- Other IDs
- U01HD040607
- Status last verified
- Jul 2014
- First submitted
- 7 Oct 2003
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Infections and Pregnancy Outcomes in Pakistan: A Collaborative Research Project in Partnership With the University of Alabama, USA
- ClinicalTrials.gov ID
- NCT00070746
- Acronym / sponsor ID
- GN 09
- Keywords
- Perinatal mortality [PNM], Neonatal mortality, Low birth weight [LBW], Spontaneous preterm delivery [SPTD], Premature rupture of membranes [PROM], Histological chorioamnionitis, Global Network, Pakistan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Alabama at Birmingham, Aga Khan University
- Study start
- Jun 2003
- Study completion
- Jul 2005
- First posted
- 10 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are large differences in health outcomes related to pregnancy and birth between developed and developing countries. This study will investigate how infections, medical history, health care behavior and psychosocial issues are associated with pregnancy outcomes in Pakistan.
Detailed description
Pakistan, the world's seventh most populous country of about 138 million people, is beset with severe problems in its maternal and child health sector. The official maternal mortality ratio for Pakistan is reported as 340 per 100,000 live births.
The overall goal to conduct a prospective observational study to identify the risk factors for adverse pregnancy outcomes including reproductive tract infections such as BV, and other physical, dental, nutritional, psychosocial, and behavioral characteristics. The primary objective is to examine the association between BV in pregnant women at 20-26 weeks gestation and various other biochemical infection markers with adverse pregnancy outcomes (i.e., perinatal mortality [PNM], neonatal mortality, low birth weight [LBW], spontaneous preterm delivery [SPTD], premature rupture of membranes [PROM], histological chorioamnionitis).
Additionally, this study will explore the relationship of various health behaviors and health status to the presence of perinatal infections. A total of 1,500 pregnant women will be enrolled in the study. A matched case-control study will be conducted at the end of the data collection period to evaluate the use of markers for the prediction of infection related perinatal mortality and infection related SPTD. All investigators and laboratory personnel will remain blinded to the identity of specimens through the use of unique study identifier numbers. Collected data will then be unblinded, analysed, and correlated with the previously collected demographic, obstetrics, and neonatal outcome, microbiology and histopathological data.
Based on the findings of this study, appropriate interventions to address reproductive tract infection (RTI) could be developed and field-tested in Pakistan. We expect that these interventions, once successfully field-tested, could be widely used to improve maternal and child survival in Pakistan and other developing countries. Given the critical state of maternal and child health in Pakistan, and considering the emerging evidence that infections could lead to poor pregnancy outcomes, this study is extremely relevant and timely, and it has the potential to contribute significantly toward the improvement of reproductive health in Pakistan. Primary outcome is perinatal mortality. Secondary outcomes include birth weight; spontaneous delivery occurring before 37 weeks gestation; rupture of fetal membranes before 37 weeks of gestation; and maternal death. The sample size was based on 25% prevalence of BV in the control group; 10 percent dropout rate; 80 percent power; and a two-tailed type I error of 0.05.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must
- be in their 20th to 26th week of pregnancy (to be confirmed by an ultrasound)
- be permanent residents (resident for the past months or intending to stay for next the 6 months) of the study site in Hyderabad, Pakistan; and,
- give informed (written or verbal) consent.
Key exclusion criteria (1 listed)
- have clinical diagnoses of life-threatening conditions (requiring immediate treatment or hospitalization, as diagnosed by the attending physician).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Website for the Global Network for Women's and Children's Health Research.Link provided by the sponsor.
- Research Triangle Institute InternationalLink provided by the sponsor.
- Aga Khan University, PakistanLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Goldenberg, MD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Vaginosis and Fetal Membranes, Premature Rupture, run by NICHD Global Network for Women's and Children's Health at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014; AzTrials last refreshed its copy on 4 Nov 2026.