Dihydroartemisinin–Piperaquine versus Sulfadoxine–Pyrimethamine Use for the Prevention of Malaria during Pregnancy

Superiority Trial of Intermittent Treatment with Dihydroartemisinin–Piperaquine versus Sulfadoxine–Pyrimethamine for the Prevention of Malaria during Pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202002644579177

Enrollment

250

Registered

2020-02-20

Start date

2020-03-02

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Dihydroartemisinin and Piperaquine

Sulfadoxine and Pyrimethamine

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: • Pregnant women aged 15-49 years • Attending antenatal clinic (ANC) for the first time in this current pregnancy • Gestation of 16-20 weeks (as assessed by LMP and/or ultra-scan) • HIV-negative pregnant women • No current history of receiving IPTp-SP • Willing to provide informed written consent • Planning to stay in Maiduguri and attending ANC and have child delivery at University of Maiduguri Teaching Hospital, Maiduguri

Exclusion criteria

Exclusion criteria: • A history of allergic reaction to sulfa drugs (SP or cotrimoxazole) or DP • Having haemoglobin level < 7 g/dl • Positive test for falciparum malaria • History of receipt of antimalarials or antibiotics with antimalarial activity (cotrimoxazole, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol) in the past month • Women with sickle cell disease • Women with high-risk pregnancies (presence of high blood pressure and diabetes) • HIV- Positive women

Design outcomes

Primary

Measure	Time frame
peripheral and/or placental parasitaemia	—

Secondary

Measure	Time frame
1. Preterm delivery at birth (defined as birth at < 37 weeks’ gestation evaluated by early ultrasound scan or calculated gestational age by date). 2. Low birth weight (<2500 g). 3. Spontaneous abortion (defined as the expulsion of a foetus before 28 weeks’ gestation). 4. Stillbirth (defined as the delivery of a dead child after 28 weeks’ gestation). 5. Gross congenital anomaly. 6. Maternal anaemia (Hb <11 g/dl) at delivery. 7. Adverse effects of SP (skin rash, anorexia, diarrhoea, dizziness, headache, itch, fatigue, nausea/vomiting, fever, swollen tongue, arrhythmia, and any other ones linked to the drug) and DP (Anorexia, dysphagia, diarrhoea, dizziness/vertigo, headache, itch, asthenia, nausea/vomiting, fever, generalized irregular twitching movement- choreoathetois, and any other one linked to the drug).	—

Measure

Time frame

1. Preterm delivery at birth (defined as birth at < 37 weeks’ gestation evaluated by early ultrasound scan or calculated gestational age by date). 2. Low birth weight (<2500 g). 3. Spontaneous abortion (defined as the expulsion of a foetus before 28 weeks’ gestation). 4. Stillbirth (defined as the delivery of a dead child after 28 weeks’ gestation). 5. Gross congenital anomaly. 6. Maternal anaemia (Hb <11 g/dl) at delivery. 7. Adverse effects of SP (skin rash, anorexia, diarrhoea, dizziness, headache, itch, fatigue, nausea/vomiting, fever, swollen tongue, arrhythmia, and any other ones linked to the drug) and DP (Anorexia, dysphagia, diarrhoea, dizziness/vertigo, headache, itch, asthenia, nausea/vomiting, fever, generalized irregular twitching movement- choreoathetois, and any other one linked to the drug).

—

Countries

Nigeria

Contacts

Public ContactJohn David Ohieku

Associate Professor University of Maiduguri

ohijodav@unimaid.edu.ng+2348036040798

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026