Malaria in PregnancyNCT03508349
Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda
A study testing IST in people with Malaria in Pregnancy, run by Jhpiego at 14 sites in Rwanda.
Trial summary
The main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria in Pregnancy
- What is being tested?
- IST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,786 participants
- Where
- 14 sitesRwanda
- Study dates
- 5 Sep 2016to 18 Mar 2019
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
- Willing to participate
Who cannot join
- • Pregnant women below the age of 18
- Not willing to participate
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Rwanda14 sites
Busoro-Gishamvu Health Center
Huye, Southern Province
Huye Police Health Center
Huye, Southern Province
Maraba Health Cente
Huye, Southern Province
Mukura Health Center
Huye, Southern Province
Rango Health Center
Huye, Southern Province
Rubona Health Center
Huye, Southern Province
Rwaniro
Huye, Southern Province
Sovu Health Center
Huye, Southern Province
Kamonyi Health Center
Kamonyi, Southern Province
Kayenzi Health Center
Kamonyi, Southern Province
Mugina Health Center
Kamonyi, Southern Province
Musambira Health Center
Kamonyi, Southern Province
Nyagihamba Health Center
Kamonyi, Southern Province
Nyamiyaga Health Center
Kamonyi, Southern Province
About this study
Official title: Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy (ISTp) on Maternal and Birth Outcomes in Selected Districts in Rwanda
The main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when compared to routine antenatal cares services alone.
Read the detailed description
More specifically, the primary objective is to understand the effect of ISTp in a context where routine antenatal care does not include malaria chemoprohylaxis and whether this intervention is protective against malaria during pregnancy. The secondary objective is to determine whether this intervention results in an improvement in other key maternal and newborn health outcomes including maternal anemia, low birth weight and prematurity. The third objective is to determine the feasibility, effectiveness and acceptability of ISTp among women who receive ISTp and among health workers who deliver this intervention.
This study will establish if testing and treating pregnant women is effective, feasible and whether it adds an additional burden to the work already being undertaken by facility-based health workers who provide antenatal care services. It is expected that the study will result in information to develop appropriate approaches that can be implemented in Rwanda in the prevention of malaria in pregnancy in addition to the use of preventive measures such as insecticide treated mosquito nets (ITNs) and case management. This information may potentially also be used by other countries with similar patterns of malaria transmission.
- Conditions
- Malaria in Pregnancy
- Being tested
- IST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISTDiagnostic test
Women in the control group will receive routine care, which does not include testing for malaria with a rapid diagnostic test unless symptomatic for malaria. Women in the intervention group will receive this additional testing for malaria at each antenatal care, regardless of whether she is symptomatic for malaria.
| Study group | Role | What they receive |
|---|---|---|
| IST using RDT | Experimental | Women presenting for their first ANC visit to facilities will be consecutively enrolled after providing informed consent. Women in the intervention group (IST+ routine care) will be tested for malaria at the health center during their ANC visits with an RDT. If positive, they will be treated with artemisinin-based combination therapy (ACT) in second or third trimester or quinine in the first trimester. Receives: Diagnostic Test: IST |
| Routine Antenatal Care | No intervention | Women presenting for their first ANC visit to facilities will be consecutively enrolled after providing informed consent. Women in the comparison group (routine care) will receive routine antenatal care services per the national guidelines. They will not be tested for malaria at each antenatal care visit unless they are symptomatic for malaria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of placental malaria at delivery (tested by PCR)
comparison of prevalence of malaria between women in intervention and control sites
Measured: at the time of delivery
Secondary outcomes (4)
Prevalence of maternal anemia at delivery
comparison of prevalence of maternal anemia between women in intervention and control sites
Measured: at the time of delivery
Prevalence of low birth weight babies (<37 weeks gestation)
comparison of prevalence of LBW between women in intervention and control sites
Measured: at the time of delivery
Prevalence of preterm births
comparison of prevalence of preterm births between women in intervention and control sites
Measured: at the time of delivery
Episodes of clinical malaria during the course of the pregnancy
description of the number of episodes of malaria detected during antenatal care visits during pregnancy
Measured: assessed at the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start5 Sep 2016
- Primary completion31 Oct 2018
- Study completion18 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malaria in PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Health facilities in high malaria transmission zones were pair matched and then randomized to be an intervention or a control facility.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,786 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Collaborators
- Rwanda Malaria and Other Parasitic Diseases Division (MOPDD), Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Reena Sethi, DrPH, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508349
- Sponsor's protocol ID
- 6829
- Status last verified
- Dec 2019
- First submitted
- 23 Jan 2018
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alruwaili M, Uwimana A, Sethi R, Murindahabi M, Piercefield E, Umulisa N, Abram A, Eckert E, Munguti K, Mbituyumuremyi A, Gutman JR, Sullivan DJ. Peripheral and Placental Prevalence of Sulfadoxine-Pyrimethamine Resistance Markers in Plasmodium falciparum among Pregnant Women in Southern Province, Rwanda. Am J Trop Med Hyg. 2023 Oct 2;109(5):1057-1062. doi: 10.4269/ajtmh.23-0225. Print 2023 Nov 1.
PubMed 37783456Uwimana A, Sethi R, Murindahabi M, Ntirandeka C, Piercefield E, Umulisa N, Abram A, Eckert E, Munguti K, Sullivan D, Uyizeye D, Mbituyumuremyi A, Gutman JR. Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy on Maternal and Birth Outcomes in Selected Districts in Rwanda: A Cluster Randomized Controlled Trial. Clin Infect Dis. 2023 Jul 5;77(1):127-134. doi: 10.1093/cid/ciad128.
PubMed 36896967
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy (ISTp) on Maternal and Birth Outcomes in Selected Districts in Rwanda
- ClinicalTrials.gov ID
- NCT03508349
- Acronym / sponsor ID
- 6829
- Conditions
- Malaria in Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,786 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Collaborators
- Rwanda Malaria and Other Parasitic Diseases Division (MOPDD), Centers for Disease Control and Prevention
- Study start
- 5 Sep 2016 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 25 Apr 2018 (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 main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when compared to routine antenatal cares services alone.
Detailed description
More specifically, the primary objective is to understand the effect of ISTp in a context where routine antenatal care does not include malaria chemoprohylaxis and whether this intervention is protective against malaria during pregnancy. The secondary objective is to determine whether this intervention results in an improvement in other key maternal and newborn health outcomes including maternal anemia, low birth weight and prematurity. The third objective is to determine the feasibility, effectiveness and acceptability of ISTp among women who receive ISTp and among health workers who deliver this intervention.
This study will establish if testing and treating pregnant women is effective, feasible and whether it adds an additional burden to the work already being undertaken by facility-based health workers who provide antenatal care services. It is expected that the study will result in information to develop appropriate approaches that can be implemented in Rwanda in the prevention of malaria in pregnancy in addition to the use of preventive measures such as insecticide treated mosquito nets (ITNs) and case management. This information may potentially also be used by other countries with similar patterns of malaria transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Health facilities in high malaria transmission zones were pair matched and then randomized to be an intervention or a control facility.
| Arm | Type | Receives |
|---|---|---|
| IST using RDT | Experimental | Diagnostic Test: ISTWomen presenting for their first ANC visit to facilities will be consecutively enrolled after providing informed consent. Women in the intervention group (IST+ routine care) will be tested for malaria at the health center during their ANC visits with an RDT. If positive, they will be treated with artemisinin-based combination therapy (ACT) in second or third trimester or quinine in the first trimester. |
| Routine Antenatal Care | No intervention | –Women presenting for their first ANC visit to facilities will be consecutively enrolled after providing informed consent. Women in the comparison group (routine care) will receive routine antenatal care services per the national guidelines. They will not be tested for malaria at each antenatal care visit unless they are symptomatic for malaria. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
- Willing to participate
Key exclusion criteria (2 listed)
- • Pregnant women below the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISTWomen in the control group will receive routine care, which does not include testing for malaria with a rapid diagnostic test unless symptomatic for malaria. Women in the intervention group will receive this additional testing for malaria at each antenatal care, regardless of whether she is symptomatic for malaria. | Diagnostic test | IST using RDT |
Primary outcome
Prevalence of placental malaria at delivery (tested by PCR)
Time frame: at the time of delivery
comparison of prevalence of malaria between women in intervention and control sites
4 secondary outcomes
Prevalence of maternal anemia at delivery
Time frame: at the time of delivery
Prevalence of low birth weight babies (<37 weeks gestation)
Time frame: at the time of delivery
Prevalence of preterm births
Time frame: at the time of delivery
Episodes of clinical malaria during the course of the pregnancy
Time frame: assessed at the time of delivery
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 6 Dec 2019.
- Derived from this study: PubMed 37783456Alruwaili M, Uwimana A, Sethi R, Murindahabi M, Piercefield E, Umulisa N, Abram A, Eckert E, Munguti K, Mbituyumuremyi A, Gutman JR, Sullivan DJ. Peripheral and Placental Prevalence of Sulfadoxine-Pyrimethamine Resistance Markers in Plasmodium falciparum among Pregnant Women in Southern Province, Rwanda. Am J Trop Med Hyg. 2023 Oct 2;109(5):1057-1062. doi: 10.4269/ajtmh.23-0225. Print 2023 Nov 1.
- Derived from this study: PubMed 36896967Uwimana A, Sethi R, Murindahabi M, Ntirandeka C, Piercefield E, Umulisa N, Abram A, Eckert E, Munguti K, Sullivan D, Uyizeye D, Mbituyumuremyi A, Gutman JR. Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy on Maternal and Birth Outcomes in Selected Districts in Rwanda: A Cluster Randomized Controlled Trial. Clin Infect Dis. 2023 Jul 5;77(1):127-134. doi: 10.1093/cid/ciad128.
- Individual participant dataSharing planned: No
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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.
Reena Sethi, DrPH principal investigator
Jhpiego
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IST in people with Malaria in Pregnancy, run by Jhpiego at 14 sites in Rwanda.
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 2 inclusion and 2 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 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Rwanda. 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?
Prevalence of placental malaria at delivery (tested by PCR) (time frame: at the time of delivery). 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 NCT03508349, which also lists 2 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 6 Dec 2019.