Pregnant WomenMIPNCT03955263
Malaria In Pregnancy in Central India
An observational study of Pregnant Women, run by Lata Medical Research Foundation, Nagpur at 1 site in India.
Trial summary
The present study is planned to be conducted at a district level women and children's hospital at Nagpur with the following objectives: Objectives: i) To assess the prevalence of asymptomatic malaria infection with all four species of malarial parasites namely P. falciparum, P. malariae, P. ovale and P. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- How many people
- 887 participants
- Where
- 1 siteIndia
- Study dates
- 28 Sep 2018to 31 Jan 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women in their first / second trimester attending Antenatal clinics at district level women and children's hospital at Nagpur
Who may be able to join
- Pregnant woman in first / second trimester of pregnancy
Who cannot join
- Pregnant woman in first / second trimester of pregnancy those do not consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Asymptomatic Malaria During Pregnancy and Its Effect on Pregnancy Outcomes in Women Attending Antenatal Clinic in Central India
The present study is planned to be conducted at a district level women and children's hospital at Nagpur with the following objectives:
Objectives:
- To assess the prevalence of asymptomatic malaria infection with all four species of malarial parasites namely P. falciparum, P. malariae, P. ovale and P. vivax during the first/second trimester of pregnancy among women attending the antenatal clinic at a secondary level urban health facility using PCR (polymerase chain reaction) for malaria parasites. ii) To determine the effect of malaria on duration of pregnancy, adverse outcomes and birth outcomes at delivery
Read the detailed description
Public Health Rationale:
Despite comprehensive malaria control programmes, control measures specifically aimed at malaria in pregnancy are not adequately available. The epidemiological data are scanty in order to develop effective policies to address this problem. The major barrier to successful eradication or elimination of malaria transmission is the inability to detect and treat asymptomatic carriers of the malarial parasites. Asymptomatic carriers do not seek treatment for infection and thus the life cycle of the infection continues. The systematic identification and treatment of individuals with asymptomatic P.falciparum and P. vivax, as part of a surveillance intervention strategy, are important for reducing the parasite reservoir and would help to decrease transmission of the disease. Data on asymptomatic carriage is not available from India.
Routine screening for malaria and anaemia followed by prompt management should be encouraged to curb the effect of malaria and anaemia on the pregnant women as well as her fetus. The present study is planned to be conducted at a district level women and children's hospital at Nagpur with the following objectives:
Objectives:
- To assess the prevalence of asymptomatic malaria infection with all four species of malarial parasites namely P. falciparum, P. malariae, P. ovale and P. vivax during the first/second trimester of pregnancy among women attending the antenatal clinic at a secondary level urban health facility using PCR (polymerase chain reaction) for malaria parasites. ii) To determine the effect of malaria on duration of pregnancy, adverse outcomes and birth outcomes at delivery
Study Design And Study Population:
This is a prospective cohort study of pregnant women in their first/second trimester of pregnancy attending the antenatal clinic at a secondary level healthcare facility at Nagpur, India.
Investigators propose collecting a two-three dried blood spot (DBS) sample for all enrolled women and symptomatic (fever with or without chills) neonates and infants at enrollment when the haemoglobin measurement is performed. Asymptomatic parasitaemia will be detected using a dual-antigen rapid diagnostic kit (RDK), microscopy, and species-specific PCR. PCR for the detection of malaria parasite would be performed at the National Institute for Research in Tribal Health (NIRTH) at Jabalpur, India
- Conditions
- Pregnant Women
- Keywords
- asymptomatic, Malaria, pregnancy, prevalence, RT-PCR
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymptomatic parasitaemia
Number of women having asymptomatic malaria which will be detected using a dual-antigen rapid diagnostic kit (RDK), microscopy, and species-specific PCR. PCR for the detection of malaria parasite would be performed at the National Institute for Research in Tribal Health (NIRTH) at Jabalpur, India.
Measured: January 2019 to December 2019
Effect of malaria on duration of pregnancy
Difference in mean gestational age at delivery or end of pregnancy among women with versus those without RT-PCR-confirmed malaria infection during pregnancy.
Measured: January 2019 to December 2019
Outcome of the pregnancy
Number of live births, still birth / miscarriage, elective termination / death after delivery
Measured: January 2019 to December 2019
Birth weight
Difference in mean birth weight among all infants and among term singleton infants born to women with versus those without RT-PCR-confirmed malaria infection during pregnancy
Measured: January 2019 to December 2019
Infant Outcome
Number of episode of Fever till 42 days of infant age among all infants and among term singleton infants born to women with versus those without RT-PCR-confirmed malaria infection during pregnancy
Measured: January 2019 to December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start28 Sep 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 887 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lata Medical Research Foundation, Nagpur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Archana Patel, MD, PhD, Principal investigator, Program Director and CFO, Lata Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955263
- Sponsor's protocol ID
- RPC#30
- Acronym
- MIP
- Status last verified
- May 2019
- First submitted
- 16 May 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Asymptomatic Malaria During Pregnancy and Its Effect on Pregnancy Outcomes in Women Attending Antenatal Clinic in Central India
- ClinicalTrials.gov ID
- NCT03955263
- Acronym / sponsor ID
- MIP / RPC#30
- Conditions
- Pregnant Women
- Keywords
- asymptomatic, Malaria, pregnancy, prevalence, RT-PCR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 887 participants (actual)
- Lead sponsor
- Lata Medical Research Foundation, NagpurUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 20 May 2019 (actual)
- 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.
The present study is planned to be conducted at a district level women and children's hospital at Nagpur with the following objectives:
Objectives:
- To assess the prevalence of asymptomatic malaria infection with all four species of malarial parasites namely P. falciparum, P. malariae, P. ovale and P. vivax during the first/second trimester of pregnancy among women attending the antenatal clinic at a secondary level urban health facility using PCR (polymerase chain reaction) for malaria parasites. ii) To determine the effect of malaria on duration of pregnancy, adverse outcomes and birth outcomes at delivery
Detailed description
Public Health Rationale:
Despite comprehensive malaria control programmes, control measures specifically aimed at malaria in pregnancy are not adequately available. The epidemiological data are scanty in order to develop effective policies to address this problem. The major barrier to successful eradication or elimination of malaria transmission is the inability to detect and treat asymptomatic carriers of the malarial parasites. Asymptomatic carriers do not seek treatment for infection and thus the life cycle of the infection continues. The systematic identification and treatment of individuals with asymptomatic P.falciparum and P. vivax, as part of a surveillance intervention strategy, are important for reducing the parasite reservoir and would help to decrease transmission of the disease. Data on asymptomatic carriage is not available from India.
Routine screening for malaria and anaemia followed by prompt management should be encouraged to curb the effect of malaria and anaemia on the pregnant women as well as her fetus. The present study is planned to be conducted at a district level women and children's hospital at Nagpur with the following objectives:
Objectives:
- To assess the prevalence of asymptomatic malaria infection with all four species of malarial parasites namely P. falciparum, P. malariae, P. ovale and P. vivax during the first/second trimester of pregnancy among women attending the antenatal clinic at a secondary level urban health facility using PCR (polymerase chain reaction) for malaria parasites. ii) To determine the effect of malaria on duration of pregnancy, adverse outcomes and birth outcomes at delivery
Study Design And Study Population:
This is a prospective cohort study of pregnant women in their first/second trimester of pregnancy attending the antenatal clinic at a secondary level healthcare facility at Nagpur, India.
Investigators propose collecting a two-three dried blood spot (DBS) sample for all enrolled women and symptomatic (fever with or without chills) neonates and infants at enrollment when the haemoglobin measurement is performed. Asymptomatic parasitaemia will be detected using a dual-antigen rapid diagnostic kit (RDK), microscopy, and species-specific PCR. PCR for the detection of malaria parasite would be performed at the National Institute for Research in Tribal Health (NIRTH) at Jabalpur, India
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women in their first / second trimester attending Antenatal clinics at district level women and children's hospital at Nagpur
Key inclusion criteria (1 listed)
- Pregnant woman in first / second trimester of pregnancy
Key exclusion criteria (1 listed)
- Pregnant woman in first / second trimester of pregnancy those do not consent
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
Asymptomatic parasitaemia
Time frame: January 2019 to December 2019
Number of women having asymptomatic malaria which will be detected using a dual-antigen rapid diagnostic kit (RDK), microscopy, and species-specific PCR. PCR for the detection of malaria parasite would be performed at the National Institute for Research in Tribal Health (NIRTH) at Jabalpur, India.
Effect of malaria on duration of pregnancy
Time frame: January 2019 to December 2019
Difference in mean gestational age at delivery or end of pregnancy among women with versus those without RT-PCR-confirmed malaria infection during pregnancy.
Outcome of the pregnancy
Time frame: January 2019 to December 2019
Number of live births, still birth / miscarriage, elective termination / death after delivery
Birth weight
Time frame: January 2019 to December 2019
Difference in mean birth weight among all infants and among term singleton infants born to women with versus those without RT-PCR-confirmed malaria infection during pregnancy
Infant Outcome
Time frame: January 2019 to December 2019
Number of episode of Fever till 42 days of infant age among all infants and among term singleton infants born to women with versus those without RT-PCR-confirmed malaria infection during pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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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.
Archana Patel, MD, PhD principal investigator
Program Director and CFO, Lata Medical Research Foundation
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 Pregnant Women, run by Lata Medical Research Foundation, Nagpur at 1 site in India.
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 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: status not confirmed, as of the sponsor's last update on 30 May 2019. 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 India. 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?
Results are not available in the source record.
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?
Asymptomatic parasitaemia (time frame: January 2019 to December 2019). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 30 May 2019; AzTrials last refreshed its copy on 3 Nov 2026.