ASPIRIN- Preterm Birth Prevention Study

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/05/006970
• Date of registration: 31-05-2016
• Prospective Registration: Yes
• Primary sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development
• Public title: ASPIRIN- Preterm Birth Prevention Study
• Scientific title: Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN) - ASPIRIN
• Date of first enrolment: 01-06-2016
• Target sample size: 11920
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14886
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Democratic Republic of the Congo, Guatemala, India, Kenya, Pakistan, Zambia

Contacts

• Name: Dr Shivaprasad S Goudar
• Affiliation: KLE Universitys J N Medical College

• Name: Dr Shivaprasad S Goudar
• Affiliation: KLE Universitys J N Medical College

Key inclusion & exclusion criteria

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)



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: P073- Preterm [premature] newborn [other]

Intervention(s)

Intervention1: Low dose Aspirin: 81 mg of aspirin administered daily beginning between 6 0/7 weeks and 13 6/7 weeks through 36 0/7 weeks or delivery
Control Intervention1: Placebo: Identical appearing placebo administered daily beginning between 6 0/7 weeks and 13 6/7 weeks through 36 0/7 weeks or delivery
Control Intervention2: Placebo: Identical appearing placebo administered daily beginning between 6 0/7 weeks and 13 6/7 weeks through 36 0/7 weeks or delivery

Primary Outcome(s)

Preterm birthTimepoint: delivery after 20 0/7 weeks and prior to 37 0/7 weeks

Secondary Outcome(s)

Antepartum hemorrhageTimepoint: Bleeding from the genital tract at any time after the 22nd week of pregnancy and before the birth of the baby

StillbirthTimepoint: Birth of a baby that shows no signs of life at birth

Postpartum hemorrhageTimepoint: Blood loss of 1000 ml or more from the genital tract after delivery and up to six weeks post-delivery

Fetal LossTimepoint: Spontaneous loss more than or equal to 16 weeks GA plus perinatal mortality

Maternal mortalityTimepoint: death of a woman during pregnancy (i.e. conception to delivery) and the puerperium (i.e. up to 42 days after delivery

Late abortionTimepoint: Spontaneous fetal loss after or equal to 16 weeks

Preterm birth less than 34 0/7 weeks of pregnancyTimepoint: live birth before 34 0/7 weeks of pregnancy are completed

Change in maternal hemoglobinTimepoint: Hemoglobin level less than 7.0 gm/dL or a 3.5 gm/dL decrease between measurements

Spontaneous abortionTimepoint: Premature expulsion of a non-viable fetus from the uterus at less than 20 weeks gestation

Preeclampsia and eclampsiaTimepoint: upto 42 days postpartum period

Small for Gestational ageTimepoint: Day of delivery

Birth weight less than 2500g and 1500gTimepoint: At Delivery

Medical termination of pregnancyTimepoint: an operation or other procedure to terminate pregnancy before the fetus is viable

Perinatal mortalityTimepoint: until 7 days after delivery

Vaginal bleedingTimepoint: Bleeding during pregnancy

Secondary ID(s)

GN-LDA.8.1, Version 1.1, March 21, 2015

NCT02409680

Source(s) of Monetary Support

Eunice Kennedy Shriver National Institute of Child Health and Human Development

Ethics review

Status: Approved
Approval date: 04/05/2016
Contact:

JNMC â?? Institutional Ethics Committee on Human Subjects Research Belgaum

Status: Approved
Approval date: 07/05/2016
Contact:

Ethics Review Committee, Lata Medical Research Foundation Nagpur

Results

• Date Completed: 11/04/2019