STOPMiP: Intermittent Screening and Treatment Or intermittent Preventive therapy for the control of Malaria in Pregnancy in Indonesia

Not Applicable

Completed

• Conditions: Malaria in pregnancy; Infections and Infestations; Plasmodium falciparum malaria, Plasmodium vivax malaria

• Registration Number: ISRCTN34010937
• Lead Sponsor: iverpool School of Tropical Medicine (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31353217 (added 30/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-08
• Study Completion: 2016-11-26
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2279

Inclusion Criteria

Pregnant women of any age and gravidity with:
1. Gestational age 16 to 30 weeks (inclusive) by last menstrual period (LMP) (if available) or fundal height or after quickening
2. Viable pregnancy (fetal heart sound detected, or other signs of fetal life such as perceived motion of fetus)
3. Willing to participate and complete the study schedule
4. Has provided written informed consent
5. Resident of study area and intending to stay in the area for the duration of the follow-up
6. Willing to give birth in a study selected health facility (Puskesmas, Polindes or hospital)

Exclusion Criteria

1. Residence outside study area or planning to move out in the 6 months following enrolment
2. Pre-existing conditions likely to cause complication in the current pregnancy (e.g. hypertension, diabetes, asthma, renal disease, liver disease, any spinal deformity)
3. Known allergy or previous adverse reaction to any of the study drugs based on information provided by the participant such as development of skin rash, severe nausea and vomiting
4. Requires cotrimoxazole prophylaxis for opportunistic infection (e.g. for women known to be HIV positive)
5. Treatment with antimalarials in the last month ( e.g mefloquine, halofantrine, lumafantrine, chloroquine) or last week ( quinine)
6. Unable to give informed consent (for example due to mental disability)
7. Severe malaria according to WHO definition requiring parenteral treatment
8. Family history of sudden death or of congenital prolongation of QTc interval, or known congenital prolongation of the QTc-interval or any known cardiac condition, such as history of symptomatic cardiac arrhythmia, bradycardia or congestive heart failure
9. Taking medicinal products that are known to prolong QTc interval

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Malaria infection at delivery (peripheral and or placental) detected by RDT, microscopy or polymerase chain reaction (PCR), or placental Histology (active) measured at the time when women deliver, except incidence of malaria which will occur anytime between enrolment and delivery when and if they are positive for malaria.