Background
Preterm birth (PTB) remains the leading cause of neonatal mortality and long term Disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) holds promise to reduce the rate of PTB substantially.
Objectives
- Nulliparous women with no more than two previous first trimester. Pregnancy losses that are treated with LDA daily beginning between 6 0/7 weeks and 13 6/7 weeks GA through 36 0/7 weeks GA will reduce the rate of preterm birth from all causes.
- Women who take antenatal daily LDA initiated at 6 0/7 to 13 6/7 weeks GA will have lower rates of:
- Small for gestational age (SGA)
- Eclampsia and preeclampsia
- Perinatal Mortality
Nulliparous women between the ages of 18 and 40, with a singleton pregnancy between 60/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin.
Daily administration of low dose (81 mg) aspirin, initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.
Primary Outcome
Secondary Outcome
Sr. No | Participants | Number |
1 | Medical Officers | 26 |
2 | ANMs & LHVs | 177 |
3 | Pharmacists | 19 |
4 | Other Staff | 6 |
5 | Total PHC Staff Trained | 288 |
6 | Sensitization of ASHAs | 580 |
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Background
Preterm birth (PTB) remains the leading cause of neonatal mortality and long term Disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) holds promise to reduce the rate of PTB substantially.
Objectives
- Nulliparous women with no more than two previous first trimester. Pregnancy losses that are treated with LDA daily beginning between 6 0/7 weeks and 13 6/7 weeks GA through 36 0/7 weeks GA will reduce the rate of preterm birth from all causes.
- Women who take antenatal daily LDA initiated at 6 0/7 to 13 6/7 weeks GA will have lower rates of:
- Small for gestational age (SGA)
- Eclampsia and preeclampsia
- Perinatal Mortality
- + Team
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- + Gallery
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- + Study Population
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Nulliparous women between the ages of 18 and 40, with a singleton pregnancy between 60/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin.
- + Intervention
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Daily administration of low dose (81 mg) aspirin, initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.
- + Expected Outcomes
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Primary Outcome
To determine whether daily LDA initiated between 6 0/7 ‐13 6/7 weeks GA and continued to 36 0/7 weeks GA reduces the risk of PTB (birth prior to 37 0/7 weeks GA).
Secondary Outcome
Secondary outcomes of interest are the rate of preeclampsia/eclampsia, small for gestational age (SGA), and perinatal mortality. - + Training
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Sr. No Participants Number 1 Medical Officers 26 2 ANMs & LHVs 177 3 Pharmacists 19 4 Other Staff 6 5 Total PHC Staff Trained 288 6 Sensitization of ASHAs 580 - + Timeline
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