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| Column | Value |
|---|---|
| Trial registration number | NCT05073718 |
|
Full text link
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 7, 2022, 8 a.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Oct. 7, 2022, 8 a.m. Source : ClinicalTrials.gov |
candelaria.serrano@isglobal.org |
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Registration date
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
2021-10-11 |
|
Recruitment status
Last imported at : Oct. 7, 2022, 8 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Nov. 3, 2022, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Aug. 5, 2022, 4:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: pregnant women up to 32 weeks of gestational age aged 18 years or older* willing to deliver at the recruitment health facilities in mozambique, in case of age below 18 years, the participant will be asked for the assent and the informed consent will be given by the legal tutor in accordance with the national regulations. |
|
Exclusion criteria
Last imported at : Aug. 5, 2022, 4:30 p.m. Source : ClinicalTrials.gov |
on regular asa treatment for pre-eclampsia prevention on long-term non-steroidal anti-inflammatory medication bleeding disorders, mainly haemophilia, hypoprothrombinaemia orvon willebrand's disease history of hypersensitivity to asa or to any of the excipients of the investigational product. history of peptic ulceration, including active, chronic or recurrent gastroduodenal ulcer; recurrent gastric discomfort history of gastric bleeding or perforation after treatment with aspirin or other non-steroidal anti-inflammatory drugs inability to cooperate with the requirements of the study severe covid-19 disease (with any of the following: respiratory rate > 30 breaths/min; severe respiratory distress; spo2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction). treatment resistant hyperemesis gravidarum hypersensitivity to nonsteroidal anti-inflammatory drugs or to tartrazine (cross-reaction) or to any of the excipients used in its composition. asthma. severe renal or hepatic insufficiency. nasal polyps associated with asthma that are induced or exacerbated by aspirin. severe covid-19 disease (with any of the following: respiratory rate > 30 breaths/min; severe respiratory distress; spo2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction). treatment resistant hyperemesis gravidarum |
|
Number of arms
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
Barcelona Institute for Global Health |
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Inclusion age min
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Nov. 3, 2022, 4 a.m. Source : ClinicalTrials.gov |
Mozambique;Spain |
|
Type of patients
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : Aug. 5, 2022, 4:30 p.m. Source : ClinicalTrials.gov |
400 |
|
primary outcome
Last imported at : Aug. 5, 2022, 4:30 p.m. Source : ClinicalTrials.gov |
Rate of composite adverse maternal and perinatal adverse outcomes including miscarriage, foetal death, preeclampsia, maternal thromboembolic complications, placental abruption, preterm birth and small for gestational age. |
|
Notes
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Oct. 12, 2021, 1 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Low dose;pregnant women", "treatment_id": 20, "treatment_name": "Acetylsalicylic acid", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |