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CompletedNCT02409680ASPIRINUpdated Nov 21, 2024Results posted

Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)

An interventional study of Low dose aspirin and Placebo in Premature Birth, sponsored by NICHD Global Network for Women's and Children's Health. Completed at 14 sites in 7 countries. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by NICHD Global Network for Women's and Children's Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
11,976
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and geographically diverse population could best be accomplished by the established infrastructure of the Global Network for Women's and Children's Health Research (GN).

Read the detailed description

Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the developed and developing 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.

Hypothesis: The investigators' primary hypothesis is that nulliparous women with no more than two previous first trimester pregnancy losses who are treated with LDA daily beginning between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) through 36 0/7 weeks GA will reduce the risk of preterm birth from all causes.

Study Design Type: Prospective randomized, placebo-controlled, double-blinded multicenter clinical trial (patient level 1:1).

Population: Nulliparous women between the ages of 18 (or local age of majority) and 40 with no more than two previous first trimester pregnancy losses or any second trimester spontaneous pregnancy loss, a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks GA confirmed by ultrasound, and no contraindications to aspirin. Other medical conditions, such as sickle-cell anemia, may be considered a contraindication per the judgment of the site investigator.

Intervention: Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA)], 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.

Outcomes:

The primary outcome is to determine whether daily LDA initiated between 6 0/7 weeks and 13 6/7 weeks and continued to 36 0/7 weeks reduces the risk of preterm birth (birth prior to 37 0/7 weeks of pregnancy) by 20%. This will be determined based on assessed date of delivery in comparison to the projected estimated date of delivery, independent of whether or not the preterm delivery is indicated or spontaneous.

Secondary outcomes include:

  • Preeclampsia and eclampsia (hypertensive disorders of pregnancy)
  • Small for gestational age
  • Perinatal mortality

Other secondary outcomes of interest are:

Maternal outcomes:

  • Vaginal bleeding
  • Antepartum hemorrhage
  • Postpartum hemorrhage
  • Maternal mortality
  • Late abortion
  • Change in maternal hemoglobin
  • Preterm, preeclampsia

Fetal outcomes:

  • Preterm birth \<34 0/7 weeks of pregnancy
  • Birth weight \<2500g and \<1500g
  • Fetal loss
  • Spontaneous abortion
  • Stillbirth
  • Medical termination of pregnancy
02

Conditions studied

  • Premature Birth

Browse trials for

Keywords

  • Preterm birth
  • Low dose aspirin
03

In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's enrollment of 11,976 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

NICHD Global Network for Women's and Children's Health is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Nulliparous women between 18 - 40 years of age. Minors who are ≥ 14 years of age may be enrolled if permitted by the country's ethical guidelines.
  • No more than two previous first trimester pregnancy losses
  • No medical to aspirin;
  • Single live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an early dating ultrasound and with presence of a heartbeat.

Exclusion criteria

Exclusion Criteria:

  • Women prescribed daily aspirin for more than 7 days;
  • Multiple gestations;
  • Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation. Subsequent discovery of a fetal anomaly is not viewed as an exclusion.);
  • \< 7.0 gm/dl at screening;
  • Any other medical conditions that may be considered a per the judgment of the site investigator (e.g., Lupus, Type 1 Diabetes, or any other known significant disease)
  • Blood pressure ≥ 140/90 (Systolic blood pressure ≥ 140 and diastolic ≥ 90 at screening)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
11,976 participants (actual)

Study arms

  • Active comparator
    Intervention Arm

    Women will be randomized equally to receive daily low dose aspirin (LDA) \[also known as acetylsalicylic acid (ASA)\] of 81 mg beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery.

    Drug: Low dose aspirin

  • Placebo comparator
    Placebo Arm

    Women will be randomized equally to receive an identical appearing placebo beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery.

    Drug: Placebo

Interventions

  • DrugLow dose aspirin

    Daily administration of low dose (81 mg) aspirin \[also known as acetylsalicylic acid (ASA\], 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.

    Also known as: Acetylsalicylic acid (ASA)

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Incidence of Preterm Birth

    The primary outcome of this study is incidence of preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks. This will be determined based on actual date of delivery in comparison to the projected estimated due date (EDD), independent of whether or not the preterm delivery is indicated or spontaneous.

    Time frame: At delivery

Secondary outcomes

  1. Incidence of Hypertensive Disorders of Pregnancy

    - Hypertensive disorders of pregnancy is defined by the characterization of evidence of a hypertensive disorder, including either preeclampsia or eclampsia occurring during the pregnancy.

    Time frame: Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth)

  2. Incidence of Small for Gestational Age (SGA)

    - Small for gestational age (SGA) as defined by the INTERGROWTH-21st standard

    Time frame: At delivery or at Day 42 after delivery

  3. Incidence of Perinatal Mortality

    - Incidence of Perinatal Mortality

    Time frame: At delivery or at Day 42 after delivery

Other outcomes

  1. Maternal Outcome 1 - Incidence of Vaginal Bleeding

    - Vaginal bleeding

    Time frame: At delivery or at Day 42 after delivery

  2. Maternal Outcome 2 - Incidence of Antepartum Hemorrhage

    - Antepartum hemorrhage

    Time frame: At delivery or at Day 42 after delivery

  3. Maternal Outcome 3 - Incidence of Postpartum Hemorrhage

    - Postpartum hemorrhage

    Time frame: At delivery or at Day 42 after delivery

  4. Maternal Outcome 4 - Incidence of Maternal Mortality

    - Incidence of Maternal Mortality

    Time frame: At delivery or at Day 42 after delivery

  5. Maternal Outcome 5 - Incidence of Late Abortion

    - Incidence of Late Abortion

    Time frame: At delivery or at Day 42 after delivery

  6. Maternal Outcome 6 - Change in Maternal Hemoglobin

    Hemoglobin \< 7.0 gm/dl at 26-30 weeks gestation or a drop of 3.5+ gm/dl from screening to 26-30 weeks gestation

    Time frame: At enrollment, 4 weeks post enrollment, and 26-30 weeks GA.

  7. Maternal Outcome 7 - Incidence of Preterm, Preeclampsia

    Early preterm delivery (\<34 weeks) and hypertensive disorders (i.e.: preeclampsia)

    Time frame: At delivery or at Day 42 after delivery

  8. Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks)

    - Early preterm delivery (\<34 weeks)

    Time frame: At delivery

  9. Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g

    - Birth weight \<2500g

    Time frame: At delivery

  10. Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g

    - Birth weight \<1500g

    Time frame: At delivery

  11. Fetal Outcome 4 - Incidence of Fetal Loss

    - Incidence of Fetal Loss

    Time frame: At delivery

  12. Fetal Outcome 5 - Incidence of Spontaneous Abortion

    - Incidence of Spontaneous Abortion

    Time frame: At delivery

  13. Fetal Outcome 6 - Incidence of All Stillbirth

    - Incidence of All stillbirth

    Time frame: At delivery

  14. Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy

    - Incidence of Medical Termination of Pregnancy

    Time frame: At delivery

07

Results

Posted Sep 8, 2021

Participant flow

Randomized, multi-country, double-masked, placebo-controlled trial of low-dose aspirin (81 mg daily) initiated between 6 weeks and 0 days of pregnancy, and 13 weeks and 6 days of pregnancy, in nulliparous women with an ultrasound confirming gestational age and a singleton viable pregnancy.

Participant flow — Overall Study
MilestoneIntervention ArmPlacebo Arm
Started59905986
Treated59435936
Included in mitt analysis57875771
Completed59755956
Not completed1530
Withdrew: Lost to follow-up1530

Outcome measures

PrimaryIncidence of Preterm Birth

The primary outcome of this study is incidence of preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks. This will be determined based on actual date of delivery in comparison to the projected estimated due date (EDD), independent of whether or not the preterm delivery is indicated or spontaneous.

Time frame:
At delivery
Reported as:
Count of participants · Participants
Incidence of Preterm Birth
ParticipantsIntervention ArmPlacebo Arm
Incidence of Preterm Birth668754
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.012 (A-priori threshold for statistical significance at 0.05 was specified.) · Risk ratio (rr): 0.89 · 95% CI 0.81 to 0.98
SecondaryIncidence of Hypertensive Disorders of Pregnancy

- Hypertensive disorders of pregnancy is defined by the characterization of evidence of a hypertensive disorder, including either preeclampsia or eclampsia occurring during the pregnancy.

Time frame:
Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth)
Reported as:
Count of participants · Participants
Incidence of Hypertensive Disorders of Pregnancy
ParticipantsIntervention ArmPlacebo Arm
Incidence of Hypertensive Disorders of Pregnancy352325
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.299 · Risk ratio (rr): 1.08 · 95% CI 0.94 to 1.25
SecondaryIncidence of Small for Gestational Age (SGA)

- Small for gestational age (SGA) as defined by the INTERGROWTH-21st standard

Time frame:
At delivery or at Day 42 after delivery
Reported as:
Count of participants · Participants
Incidence of Small for Gestational Age (SGA)
ParticipantsIntervention ArmPlacebo Arm
Incidence of Small for Gestational Age (SGA)15061564
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.171 · Risk ratio (rr): 0.95 · 95% CI 0.90 to 1.01
SecondaryIncidence of Perinatal Mortality

- Incidence of Perinatal Mortality

Time frame:
At delivery or at Day 42 after delivery
Reported as:
Count of participants · Participants
Incidence of Perinatal Mortality
ParticipantsIntervention ArmPlacebo Arm
Incidence of Perinatal Mortality264309
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.048 · Risk ratio (rr): 0.86 · 95% CI 0.73 to 1.00
Other pre-specifiedMaternal Outcome 1 - Incidence of Vaginal Bleeding

- Vaginal bleeding

Time frame:
At delivery or at Day 42 after delivery
Reported as:
Count of participants · Participants
Maternal Outcome 1 - Incidence of Vaginal Bleeding
ParticipantsIntervention ArmPlacebo Arm
Maternal Outcome 1 - Incidence of Vaginal Bleeding214246
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.125 · Risk ratio (rr): 0.87 · 95% CI 0.73 to 1.04
Other pre-specifiedMaternal Outcome 2 - Incidence of Antepartum Hemorrhage

- Antepartum hemorrhage

Time frame:
At delivery or at Day 42 after delivery
Reported as:
Count of participants · Participants
Maternal Outcome 2 - Incidence of Antepartum Hemorrhage
ParticipantsIntervention ArmPlacebo Arm
Maternal Outcome 2 - Incidence of Antepartum Hemorrhage2625
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.900 · Risk ratio (rr): 1.03 · 95% CI 0.60 to 1.79
Other pre-specifiedMaternal Outcome 3 - Incidence of Postpartum Hemorrhage

- Postpartum hemorrhage

Time frame:
At delivery or at Day 42 after delivery
Reported as:
Count of participants · Participants
Maternal Outcome 3 - Incidence of Postpartum Hemorrhage
ParticipantsIntervention ArmPlacebo Arm
Maternal Outcome 3 - Incidence of Postpartum Hemorrhage5443
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.274 · Risk ratio (rr): 1.25 · 95% CI 0.84 to 1.86
Other pre-specifiedMaternal Outcome 4 - Incidence of Maternal Mortality

- Incidence of Maternal Mortality

Time frame:
At delivery or at Day 42 after delivery
Reported as:
Count of participants · Participants
Maternal Outcome 4 - Incidence of Maternal Mortality
ParticipantsIntervention ArmPlacebo Arm
Maternal Outcome 4 - Incidence of Maternal Mortality912
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.512 · Risk ratio (rr): 0.75 · 95% CI 0.32 to 1.78
Other pre-specifiedMaternal Outcome 5 - Incidence of Late Abortion

- Incidence of Late Abortion

Time frame:
At delivery or at Day 42 after delivery
Reported as:
Count of participants · Participants
Maternal Outcome 5 - Incidence of Late Abortion
ParticipantsIntervention ArmPlacebo Arm
Maternal Outcome 5 - Incidence of Late Abortion2330
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.331 · Risk ratio (rr): 0.77 · 95% CI 0.45 to 1.31
Other pre-specifiedMaternal Outcome 6 - Change in Maternal Hemoglobin

Hemoglobin \< 7.0 gm/dl at 26-30 weeks gestation or a drop of 3.5+ gm/dl from screening to 26-30 weeks gestation

Time frame:
At enrollment, 4 weeks post enrollment, and 26-30 weeks GA.
Reported as:
Count of participants · Participants
Maternal Outcome 6 - Change in Maternal Hemoglobin
ParticipantsIntervention ArmPlacebo Arm
Maternal Outcome 6 - Change in Maternal Hemoglobin290333
Other pre-specifiedMaternal Outcome 7 - Incidence of Preterm, Preeclampsia

Early preterm delivery (\<34 weeks) and hypertensive disorders (i.e.: preeclampsia)

Time frame:
At delivery or at Day 42 after delivery
Reported as:
Count of participants · Participants
Maternal Outcome 7 - Incidence of Preterm, Preeclampsia
ParticipantsIntervention ArmPlacebo Arm
Maternal Outcome 7 - Incidence of Preterm, Preeclampsia821
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.015 · Risk ratio (rr): 0.38 · 95% CI 0.17 to 0.85
Other pre-specifiedFetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks)

- Early preterm delivery (\<34 weeks)

Time frame:
At delivery
Reported as:
Count of participants · Participants
Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks)
ParticipantsIntervention ArmPlacebo Arm
Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks)189230
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.039 · Risk ratio (rr): 0.75 · 95% CI 0.61 to 0.93
Other pre-specifiedFetal Outcome 2 - Incidence of Actual Birth Weight <2500g

- Birth weight \<2500g

Time frame:
At delivery
Reported as:
Count of participants · Participants
Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g
ParticipantsIntervention ArmPlacebo Arm
Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g10781153
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.073 · Risk ratio (rr): 0.93 · 95% CI 0.87 to 1.01
Other pre-specifiedFetal Outcome 3 - Incidence of Actual Birth Weight <1500g

- Birth weight \<1500g

Time frame:
At delivery
Reported as:
Count of participants · Participants
Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g
ParticipantsIntervention ArmPlacebo Arm
Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g78101
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.084 · Risk ratio (rr): 0.87 · 95% CI 0.57 to 1.33
Other pre-specifiedFetal Outcome 4 - Incidence of Fetal Loss

- Incidence of Fetal Loss

Time frame:
At delivery
Reported as:
Count of participants · Participants
Fetal Outcome 4 - Incidence of Fetal Loss
ParticipantsIntervention ArmPlacebo Arm
Fetal Outcome 4 - Incidence of Fetal Loss303353
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.039 · Risk ratio (rr): 0.86 · 95% CI 0.73 to 1.00
Other pre-specifiedFetal Outcome 5 - Incidence of Spontaneous Abortion

- Incidence of Spontaneous Abortion

Time frame:
At delivery
Reported as:
Count of participants · Participants
Fetal Outcome 5 - Incidence of Spontaneous Abortion
ParticipantsIntervention ArmPlacebo Arm
Fetal Outcome 5 - Incidence of Spontaneous Abortion134152
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.261 · Risk ratio (rr): 0.88 · 95% CI 0.70 to 1.10
Other pre-specifiedFetal Outcome 6 - Incidence of All Stillbirth

- Incidence of All stillbirth

Time frame:
At delivery
Reported as:
Count of participants · Participants
Fetal Outcome 6 - Incidence of All Stillbirth
ParticipantsIntervention ArmPlacebo Arm
Fetal Outcome 6 - Incidence of All Stillbirth141166
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.141 · Risk ratio (rr): 0.85 · 95% CI 0.68 to 1.06
Other pre-specifiedFetal Outcome 7 - Incidence of Medical Termination of Pregnancy

- Incidence of Medical Termination of Pregnancy

Time frame:
At delivery
Reported as:
Count of participants · Participants
Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy
ParticipantsIntervention ArmPlacebo Arm
Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy4230
Statistical analysis
  • Placebo Arm · Cochran-Mantel-Haenszel · p = 0.157 · Risk ratio (rr): 1.40 · 95% CI 0.88 to 2.23

Adverse events

Collected over Adverse events were monitored continuously throughout the study (from enrollment through 6-weeks post delivery) and recorded every 2-weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Arm9/5,943 (0.2%)832/5,943 (14%)—
Placebo Arm12/5,936 (0.2%)857/5,936 (14.4%)—
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventIntervention ArmPlacebo Arm
Neonatal death up to 28 daysPregnancy, puerperium and perinatal conditions163/5943190/5936
Fetal lossPregnancy, puerperium and perinatal conditions142/5943162/5936
Pre-eclampsia or eclampsiaPregnancy, puerperium and perinatal conditions150/5943141/5936
Hypertension admission or medical visit before deliveryCardiac disorders120/5943106/5936
OtherPregnancy, puerperium and perinatal conditions57/594357/5936
Preterm labour or preterm birth evaluation before deliveryPregnancy, puerperium and perinatal conditions45/594356/5936
Miscarriage, abortion, or medical termination of pregnancyPregnancy, puerperium and perinatal conditions51/594354/5936
Fever or infectionInfections and infestations54/594346/5936
Post-partum harmorrhagePregnancy, puerperium and perinatal conditions50/594343/5936
Congenital anomalyCongenital, familial and genetic disorders32/594336/5936

Baseline characteristics

Women who were eligible according to the modified intention-to-treat (mITT) criteria and included in the mITT analysis.

Age, Customized
Age, Customized(Participants)Intervention ArmPlacebo ArmTotal
Maternal Age (years) — <20 years223322734506
Maternal Age (years) — 20-29 years342933726801
Maternal Age (years) — >29 years125126251
Sex: Female, Male
Sex: Female, Male(Participants)Intervention ArmPlacebo ArmTotal
Female5787577111558
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Intervention ArmPlacebo ArmTotal
Count of participants——0
Maternal Education
Maternal Education(Participants)Intervention ArmPlacebo ArmTotal
No formal schooling8308281658
1-6 years of schooling8578561713
7-12 years of scholling347034546924
>= 13 years of schooling6296321261
Missing112
Number of pregnancies
Number of pregnancies(Participants)Intervention ArmPlacebo ArmTotal
05274522610500
1451469920
26276138
Projected gestational age at enrollment
Projected gestational age at enrollment(weeks)Intervention ArmPlacebo ArmTotal
Median10.1 (8.6 to 12.0)10.1 (8.6 to 12.0)10.1 (8.6 to 12.0)
Maternal Height
Maternal Height(cm)Intervention ArmPlacebo ArmTotal
Mean153.1 ± 6.9153.1 ± 7.0153.1 ± 7.0
Maternal Weight
Maternal Weight(kg)Intervention ArmPlacebo ArmTotal
Mean49.3 ± 8.949.2 ± 8.749.2 ± 8.8

6 further baseline measures are reported on the registry.

08

Study locations

14 sites
  • University of Alabama, Birmingham
    Birmingham, Alabama 35233, United States
  • University of Colorado, Denver
    Denver, Colorado 80045, United States
  • Indiana University
    Indianapolis, Indiana 46202, United States
  • Boston University
    Boston, Massachusetts 02215, United States
  • Columbia University
    New York, New York 10032, United States
  • University of North Carolina, Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Kinshasa School of Public Health
    Kinshasa, Congo, The Democratic Republic of the
  • Institute of Nutrition of Central America and Panama (INCAP)
    Guatemala City, 01015, Guatemala
  • KLE University's Jawaharlal Nehru Medical College
    Belgaum, Karnataka, India
  • Lata Medical Research Foundation
    Nagpur, India
  • Moi University School of Medicine
    Eldoret, 30100, Kenya
  • The Aga Khan University
    Karachi, 74800, Pakistan
  • University Teaching Hospital
    Lusaka, Zambia
09

References and documents

Publications

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  • Anderson RN, Smith BL. Deaths: leading causes for 2001. Natl Vital Stat Rep. 2003 Nov 7;52(9):1-85. PubMed 14626726 ↗
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  • Duley L, Henderson-Smart DJ, Knight M, King JF. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2004;(1):CD004659. doi: 10.1002/14651858.CD004659. PubMed 14974075 ↗
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  • Hoffman MK, Goudar SS, Kodkany BS, Metgud M, Somannavar M, Okitawutshu J, Lokangaka A, Tshefu A, Bose CL, Mwapule A, Mwenechanya M, Chomba E, Carlo WA, Chicuy J, Figueroa L, Garces A, Krebs NF, Jessani S, Zehra F, Saleem S, Goldenberg RL, Kurhe K, Das P, Patel A, Hibberd PL, Achieng E, Nyongesa P, Esamai F, Liechty EA, Goco N, Hemingway-Foday J, Moore J, Nolen TL, McClure EM, Koso-Thomas M, Miodovnik M, Silver R, Derman RJ; ASPIRIN Study Group. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial. Lancet. 2020 Jan 25;395(10220):285-293. doi: 10.1016/S0140-6736(19)32973-3. PubMed 31982074 ↗
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Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02409680
Lead sponsor
NICHD Global Network for Women's and Children's Health
Collaborators
Thomas Jefferson University, Jawaharlal Nehru Medical College
Responsible party
Sponsor
First posted
Apr 7, 2015
Start date
Mar 23, 2016
Primary completion
Apr 11, 2019
Completion
Apr 11, 2019
Results posted
Sep 8, 2021
Last update
Nov 21, 2024

Study contacts

Marion Koso-Thomas, MD
study director · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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