DSIR Recognized | FWA Approved - FWA00012971

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
  • Dr. Archana Patel | MD, DNB, MSCE
  • Dr. Patricia L. Hibberd | MD, PhD
  • Dr. Prabir Kumar B. Das | MD
  • Dr. Savita Bhargav
  • Dr. Kunal Kurhe
  • Dr. Atul Chopde
  • Dr. Atul Andelkar
  • Dr. Nitesh Nikose
  • Dr. Manisha Chikte
  • Dr. Anukampa Kumbhare
  • Dr. Takshashila Taksande

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

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.
Sr. NoParticipantsNumber
1Medical Officers26
2ANMs & LHVs177
3Pharmacists19
4Other Staff6
5Total PHC Staff Trained288
6Sensitization of ASHAs580
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ASPIRIN Home

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
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Team
  • Dr. Archana Patel | MD, DNB, MSCE
  • Dr. Patricia L. Hibberd | MD, PhD
  • Dr. Prabir Kumar B. Das | MD
  • Dr. Savita Bhargav
  • Dr. Kunal Kurhe
  • Dr. Atul Chopde
  • Dr. Atul Andelkar
  • Dr. Nitesh Nikose
  • Dr. Manisha Chikte
  • Dr. Anukampa Kumbhare
  • Dr. Takshashila Taksande
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Gallery
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Study Population

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.

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Intervention

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.

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Expected Outcomes

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.
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Training
Sr. NoParticipantsNumber
1Medical Officers26
2ANMs & LHVs177
3Pharmacists19
4Other Staff6
5Total PHC Staff Trained288
6Sensitization of ASHAs580
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Timeline
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