AzTrials
AzTrials

Maternal Infection Affecting NewbornMISTNCT01572532

Maternal Genitourinary Infections and Adverse Perinatal Outcomes

A study testing Screening treatment and referral in people with Maternal Infection Affecting Newborn, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary aim of this study is to determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19 weeks) on preterm live birth in Sylhet district, Bangladesh. Read more about this study

Who is it for?
Ages 1 minute to 47 yearsHealthy volunteers can take part
Conditions the study is for
Maternal Infection Affecting Newborn
What is being tested?
Screening treatment and referral
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,712 participants
Where
1 siteBangladesh
Study dates
Aug 2010to 17 Mar 2016
Phase
Interventional
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 1 minute to 47 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • All women who become pregnant in the study area will be eligible to participate in the trial. We will identify women with missed periods through monthly surveillance by health workers and identify pregnant women by positive pregnancy test conducted by CHWs. Thus enrollment may begin as soon as 5 weeks gestation and will continue until 19 weeks gestation. A sample of women who are enrolled early in gestation (<12 weeks), will be considered for enrolment in the gestational age sub-study. The first CHW visit for screening for abnormal vaginal flora and urinary tract infection will occur after the initial enrollment between 13-19 weeks. Their infants will enrolled as well.

Who cannot join

  • Subjects will be excluded from the study if they have no recall or uncertain report of LMP (due to lactational amenorrhea, recent discontinuation of contraceptive or irregular menses), history of irregular bleeding due to injectable depoprovera, or history of severe chronic disease based on their self-reported history on a medical history checklist. For women reporting a missed period during pregnancy surveillance, the CHW will perform a urine pregnancy test to confirm the pregnancy and keep a log of all positive pregnancy tests and LMP.
  • Pregnant women who are uncertain or refuse to participate at the initial visit will be allowed time to consider and enroll at the next study visit if they still meet inclusion criteria. Women will be given information regarding the study and CHWs will answer questions for both themselves and the family. If a woman is not certain whether she would like to participate, she will be allowed 1 week to consider participation, and the CHW will return in 1 week to revisit participation and answer any additional questions. If the woman refuses to participate at any visit, she will no longer be approached to participate.
  • Families can withdraw from the study at any time, and study staff will be available to answer questions families may have at any time.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • Community Based

    Sylhet

Other trials in Bangladesh

About this study

Official title: Maternal Genitourinary Infections and Adverse Perinatal Outcomes in Sylhet District, Bangladesh

The primary aim of this study is to determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19 weeks) on preterm live birth in Sylhet district, Bangladesh.

Hypothesis 1: Community-based screening and treatment of abnormal vaginal flora (Nugent score >4) and urinary tract infections in early pregnancy (13-19 weeks) will reduce the population rate of preterm live birth by at least 15%.

Read more

The secondary aims of this study are:

  • To determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections on the:
  • proportion of pregnancies with outcomes occurring prior to 37 weeks (late miscarriage, preterm still birth and preterm live birth); and
  • proportion of babies with early onset neonatal sepsis.
  • To determine the prevalence of abnormal vaginal flora and urinary tract infections, including asymptomatic bactiuria, among pregnant women in Sylhet district, Bangladesh.
  • To evaluate the accuracy of simple, low-cost, point of care diagnostic tests for detecting bacterial vaginosis and urinary tract infections by community health workers in a rural, developing country setting.
Read the detailed description

Burden of Maternal Genitourinary Tract Infections: Genital and urinary tract (GU) infections may be due to endogenous or sexually transmitted pathogens, and are estimated to affect up to 41% of women of reproductive age globally, although there is wide regional, country, and population specific variation (Table 1). These estimates, however, may underestimate the burden in developing countries, as 60-80% of GU infections are asymptomatic in pregnant women [1], and furthermore many women never receive appropriate medical care in resource poor settings.

Several epidemiologic studies have been conducted in Bangladesh reporting the prevalence of GU infections in different populations [2-15]. Genital tract infections, particularly sexually transmitted infections are common among urban and high risk populations, i.e. commercial sex workers. In rural Bangladesh, the burden of diseases associated with bacterial vaginosis (BV) (5.9-18.9%) [3, 4] and asymptomatic bactiuria (12%) are high [12]. In urban areas, mostly Dhaka, the prevalence of BV is higher; one study reported a prevalence of 28% [8]. There is no known data on the prevalence of intermediate vaginal flora in Bangladesh. The prevalence of sexually transmitted infections including Gonorrhea, Chlamydia, Trichomonas and Syphilis are high among high risk urban populations of Bangladesh but generally low in rural areas. Given these prevalence data, we postulate that among pregnant women of rural Sylhet district in Bangladesh, BV and UTI are the most prevalent GU infections.

Rationale for screening and treating asymptomatic women The rationale for treating asymptomatic bacterial vaginosis (Nugent score 7-10) and asymptomatic intermediate flora (Nugent score 4-6) is based on data: 1) showing their association with adverse pregnancy outcomes[38], and 2) several promising trials showing that treatment may reduce preterm birth[39, 40]. Up to 84% of bacterial vaginosis cases are asymptomatic [23]. In a meta-analysis of 32 studies in developed and developing countries by Leitich et al, asymptomatic BV (Nugent score 7-10) was associated with a 6.32 times elevated risk of late miscarriage (95% CI 3.65-10.94) and 2.16 times (95% CI 1.56-3.00) increased risk of preterm birth. The association with preterm birth was higher when BV was detected in early pregnancy (<16 weeks, OR 2.97, 95% CI 1.48-5.98)[38]. Among women with a prior history of preterm birth, Hauth and colleagues found that screening and treatment of asymptomatic BV (Nugent score 7-10) with metronidazole and erythromycin at 22 weeks gestation significantly reduced the incidence of preterm birth from 46% in the placebo group to 31% in the treatment group [41]. In the multi-center NICHD BV trial, 1953 women with asymptomatic BV between 16-24 weeks of gestation were randomized to receive two doses of metronidazole (2g) or placebo; however, treatment did not significantly affect preterm delivery or other adverse perinatal outcomes [42].

Intermediate vaginal flora (Nugent score 4-6) is a heterogeneous condition which has been also associated with elevated risk of preterm birth and neonatal infections [43-46]. Intermediate vaginal flora comprises 15% of all abnormal vaginal flora (Nugent score >=4) [39]. In a recent trial, Ugwumadu et al reported that early (12-22 weeks of gestation) screening and treatment for abnormal vaginal flora (Nugent score >4) with 5 days of oral clindamycin resulted in a significant reduction in spontaneous preterm birth rate (12% in placebo vs. 5% in treatment group) and late miscarriage (13-24 weeks; 4% in placebo vs. 1% in treatment group) [39]. Similarly, Lamont et al reported that early (13-20 week) treatment of abnormal vaginal flora (Nugent score >4) with intravaginal clindamycin reduced the incidence of preterm birth by 60% [40]. Potential explanations for the treatment effect in the 2 later trials may include: 1) the earlier timing of treatment, prior to the amniotic membranes sealing the uterus at 20 weeks [47], which may thus prevent early ascension of bacteria into the intrauterine cavity; 2) antibiotic choice: 5-7 day course of clindamycin, which has greater activity against Mobiluncus and atypical Mycoplasma species vs. 2 days of metronidazole [26]; and 3) treatment of abnormal vaginal flora in Ugwumadu et al and Lamont et al, vs. treatment of BV only in the NICHD trial. A Cochrane meta-analysis concluded that the risk of preterm birth was significantly reduced by treatment of abnormal vaginal flora (Nugent score >4) (2 trials, 894 women; OR 0.51, 95% CI 0.32-0.81). Thus, in low-resource settings such as in rural Bangladesh, where both BV and preterm birth are prevalent, treatment of abnormal vaginal flora in early pregnancy may hold promise in reducing the incidence of preterm birth, and an evaluation in well-conducted community-based randomized trials is needed.

Being tested
Screening treatment and referral
Keywords
Adverse Perinatal Outcomes, Treatment of abnormal vaginal flora

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Screening treatment and referralOther

    Also called Screening and Treatment of Abnormal Vaginal Flora, Screening and Treatment of Urinary Tract Infections

    Women who are symptomatic at any study visit will be immediately referred to the sub-district hospital for full evaluation and treatment and will be visited on the following day to follow clinical status and ensure referral compliance. Referral will be reinforced by arranging transportation to the sub-district hospital and payment of hospital fees if the family is unable to afford out-of-pocket expenses. CHWs will conduct a home visit to women with positive test results within 24 hours of receiving the results to initiate treatment. All asymptomatic women will be treated for positive test results. For symptomatic women, the CHW will confirm the woman's clinical and treatment status, and provide treatment to those women who have not already received the appropriate treatment at the sub-district hospital for their infection.

    Antibiotic Treatment Regimens AVF: Oral clindamycin 300 mg per oral (po) twice daily (bid) for 5 days.UTI: Macrobid/Nitrofurantoin 100 mg po bid x 7 days.

Study groups in NCT01572532
Study groupRoleWhat they receive
Intervention Screening and TreatmentExperimentalCHWs will collect urine and vaginal samples for all women enrolled. In the control clusters, every eighth woman enrolled will receive the screening-treatment protocol in order to determine the baseline prevalence of these infections in the control areas for comparison. Vaginal specimens will be collected via sterile self-administered vaginal swabs. The women will be instructed by the CHW to insert a Dacron swab ~4-5 cm into the vagina, allow the swab to stand for 15 seconds, and then rotate 360 degrees prior to withdrawal. The CHW will gently roll out the swab onto a plain glass slide and allow to air dry prior to transport to Sylhet field laboratory. A midstream urine specimen will be obtained for urine culture. The mother will be instructed to separate the labia and collect 20-30mL of midstream urine into a sterile container which will be immediately refrigerated in a cool specimen box.
Receives: Other: Screening treatment and referral
Control ArmNo interventionStandard care will be administered, including antenatal and postnatal care. In the control clusters, every eighth woman enrolled will receive the screening-treatment protocol in order to determine the baseline prevalence of these infections in the control areas for comparison.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of preterm births reduced by community-based screening and treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19 weeks)

    Determine the impact of community-based screening and treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19 weeks) on preterm live birth in Sylhet district, Bangladesh.

    Measured: 5 years

Secondary outcomes (4)
  1. Proportion of early outcomes

    Proportion of pregnancies with outcomes occurring prior to 37 weeks (late miscarriage, preterm still birth and preterm live birth) in Sylhet, Bangladesh

    Measured: 5 years

  2. Proportion of infants with neonatal sepsis

    Proportion of babies with early onset neonatal sepsis in Sylhet, Bangladesh

    Measured: 5 years

  3. Prevalance abnormal vaginal flora

    Prevalence of abnormal vaginal flora and urinary tract infections, including asymptomatic bactiuria, among pregnant women in Sylhet district, Bangladesh

    Measured: 5 years

  4. Accuracy of diagnostic tests for detecting bacterial vaginosis

    Accuracy of simple, low-cost, point of care diagnostic tests for detecting bacterial vaginosis and urinary tract infections by community health workers in a rural, developing country setting (Sylhet, Bangladesh)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2012 (estimated)
  2. Study startAug 2010
  3. Primary completion17 Mar 2016
  4. Study completion17 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
9,712 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01572532
Sponsor's protocol ID
IRB00003063
Other IDs
1R01HD066156-01
Acronym
MIST
Status last verified
Jun 2023
First submitted
15 Dec 2011
Last updated
26 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee AC, Mullany LC, Quaiyum M, Mitra DK, Labrique A, Christian P, Ahmed P, Uddin J, Rafiqullah I, DasGupta S, Rahman M, Koumans EH, Ahmed S, Saha SK, Baqui AH; Projahnmo Study Group in Bangladesh. Effect of population-based antenatal screening and treatment of genitourinary tract infections on birth outcomes in Sylhet, Bangladesh (MIST): a cluster-randomised clinical trial. Lancet Glob Health. 2019 Jan;7(1):e148-e159. doi: 10.1016/S2214-109X(18)30441-8.

    PubMed 30554751
  • Lee ACC, Whelan R, Bably NN, Schaeffer LE, Rahman S, Ahmed S, Moin SMI, Begum N, Quaiyum MA, Rosner B, Litch JA, Baqui AH, Wylie BJ. Prediction of gestational age with symphysis-fundal height and estimated uterine volume in a pregnancy cohort in Sylhet, Bangladesh. BMJ Open. 2020 Mar 12;10(3):e034942. doi: 10.1136/bmjopen-2019-034942.

    PubMed 32169927
  • Lee AC, Mullany LC, Ladhani K, Uddin J, Mitra D, Ahmed P, Christian P, Labrique A, DasGupta SK, Lokken RP, Quaiyum M, Baqui AH; Projahnmo Study Group. Validity of Newborn Clinical Assessment to Determine Gestational Age in Bangladesh. Pediatrics. 2016 Jul;138(1):e20153303. doi: 10.1542/peds.2015-3303. Epub 2016 Jun 16.

    PubMed 27313070
  • Lee AC, Quaiyum MA, Mullany LC, Mitra DK, Labrique A, Ahmed P, Uddin J, Rafiqullah I, DasGupta S, Mahmud A, Koumans EH, Christian P, Saha S, Baqui AH; Projahnmo Study Group. Screening and treatment of maternal genitourinary tract infections in early pregnancy to prevent preterm birth in rural Sylhet, Bangladesh: a cluster randomized trial. BMC Pregnancy Childbirth. 2015 Dec 7;15:326. doi: 10.1186/s12884-015-0724-8.

    PubMed 26643558

Questions about this trial

What is this clinical trial studying?

A study testing Screening treatment and referral in people with Maternal Infection Affecting Newborn, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.

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 1 inclusion and 3 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 26 Jun 2023. 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 Bangladesh. 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.

What does the primary outcome measure?

Number of preterm births reduced by community-based screening and treatment of abnormal vaginal flora and urinary tract infections in early pregnancy (13-19 weeks) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01572532, which also lists 4 linked publications.

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 26 Jun 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in