ASPIRIN- Preterm Birth Prevention Study

Phase 3

Completed

Conditions: Preterm [premature] newborn [other],

Registration Number: CTRI/2016/05/006970

Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development

Brief Summary: 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 investigatorsâ€™ 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 rate 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 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 12 6/7 weeks GA confirmed by ultrasound, and no contraindications to aspirin. Intervention: Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA)], initiated between 6 0/7 weeks and 12 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 12 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 iatrogenic or spontaneous. Secondary outcomes include:Preeclampsia and eclampsia, SGA,Perinatal mortality,Other secondary outcomes of interest are:Maternal outcomes:Vaginal bleeding, Antepartum hemorrhage,Postpartum hemorrhage,Maternal mortality,Late abortion,Change in maternal hemoglobin,Fetal outcomes: Rate of preterm birth <34 0/7 weeks of pregnancy,Birth weight <2500g and <1500g,Fetal loss,Spontaneous abortion,Stillbirth,Medical termination of pregnancy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 11920

Inclusion Criteria

Nulliparous women between 18 â€“ 40 years of age.
No more than two previous first trimester pregnancy losses -No medical contraindications 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 heart rate greater than 110 bpm.

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 -Hemoglobin < 7.0 gm/dl at screening -Any other medical conditions that may be considered a contraindication per the judgment of the site investigator (e.g., Lupus, Type 1 Diabetes, hypertension, or any other known significant disease).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preterm birth	delivery after 20 0/7 weeks and prior to 37 0/7 weeks

Secondary Outcome Measures

Name	Time	Method
Small for Gestational age	Day of delivery
Perinatal mortality	until 7 days after delivery
Vaginal bleeding	Bleeding during pregnancy
Postpartum hemorrhage	Blood loss of 1000 ml or more from the genital tract after delivery and up to six weeks post-delivery
Fetal Loss	Spontaneous loss more than or equal to 16 weeks GA plus perinatal mortality
Preeclampsia and eclampsia	upto 42 days postpartum period
Antepartum hemorrhage	Bleeding from the genital tract at any time after the 22nd week of pregnancy and before the birth of the baby
Maternal mortality	death of a woman during pregnancy (i.e. conception to delivery) and the puerperium (i.e. up to 42 days after delivery
Late abortion	Spontaneous fetal loss after or equal to 16 weeks
Spontaneous abortion	Premature expulsion of a non-viable fetus from the uterus at less than 20 weeks gestation
Stillbirth	Birth of a baby that shows no signs of life at birth
Medical termination of pregnancy	an operation or other procedure to terminate pregnancy before the fetus is viable
Birth weight less than 2500g and 1500g	At Delivery
Change in maternal hemoglobin	Hemoglobin level less than 7.0 gm/dL or a 3.5 gm/dL decrease between measurements
Preterm birth less than 34 0/7 weeks of pregnancy	live birth before 34 0/7 weeks of pregnancy are completed

Trial Locations

Locations (2): Jawaharlal Nehru Medical CollegeBelgaum
🇮🇳
Belgaum, KARNATAKA, India
Lata Medical Research Foundation nagpur
🇮🇳
Nagpur, MAHARASHTRA, India
Jawaharlal Nehru Medical CollegeBelgaum
🇮🇳Belgaum, KARNATAKA, India
Bhalchandra S Kodkany
Principal investigator
9448141470
drkodkany@jnmc.edu