ClinicalTrials.gg
Not yet recruitingNCT07745595Updated Aug 12, 2026

Low Dose Aspirin vs Placebo in Prevention of Recurrent Spontaneous Preterm Labour

An interventional study of Low-dose Aspirin and Placebo in Preterm Labor and Premature Birth, sponsored by University of Health Sciences Lahore. Not yet recruiting. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Primary conditionPremature BirthRegistry: Obstetric Labor, PrematureReclassifiedWhy we changed it
Registry
Obstetric Labor, Premature — the first condition term the registry derived for this study.
ClinicalTrials.gg
Premature Birth
Why
  1. The study's listed conditions name Premature Birth, a narrower term within Obstetric Labor, Premature.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Preterm birth-defined as delivery before 37 weeks of gestation-is a leading cause of neonatal morbidity and mortality worldwide, particularly in resource-limited settings. Women with a history of spontaneous preterm birth face a significantly higher risk of experiencing premature labor in subsequent pregnancies. Impaired uteroplacental blood flow, inflammation, and abnormal clot formation are key contributing factors to spontaneous preterm delivery.

Low-dose aspirin is an affordable, widely available medication that exerts anti-inflammatory and antithrombotic effects by inhibiting platelet aggregation and prostaglandin synthesis. This study aims to evaluate whether low-dose aspirin (75 mg daily), initiated between 8 and 16 weeks of gestation, can effectively reduce the incidence of recurrent spontaneous preterm labor in pregnant women with a prior history of premature delivery compared to a placebo. Participants will be monitored throughout their pregnancy up to 36 weeks or delivery to evaluate gestational age at birth and labor outcomes.

02

Conditions studied

  • Preterm Labor
  • Premature Birth

Browse trials for

03

In context

Premature Birth Reclassified

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

This study's planned enrollment of 162 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University of Health Sciences Lahore is the lead sponsor of 83 studies on the registry; 52 are open to participants now.

Compared within Premature Birth, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Obstetric Labor, Premature. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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

  1. Age > 18 years.
  2. Singleton alive pregnancy.
  3. History of spontaneous preterm birth (22 to 37 weeks of gestation).
  4. (Hb) > 10 g/dL.
  5. Absence of fetal anomalies on ultrasound examination.

Exclusion criteria

Exclusion Criteria:

  1. Primigravida.
  2. Multiple pregnancy.
  3. Maternal age > 40 years.
  4. Known history of allergy or to aspirin.
  5. Known maternal comorbidities including Pregnancy-Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), cardiac disease, HELLP syndrome, thrombocytopenia, thrombocytopathy, or epilepsy.
  6. Presence of a cervical cerclage prior to study enrollment.
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.

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).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
162 participants (estimated)

Study arms

  • Experimental
    Group-I: Aspirin Group

    Participants receive low-dose aspirin (75 mg once daily orally) starting from 8-16 weeks of gestation up to 36 weeks of gestation or until delivery, along with standard care (progesterone and cervical cerclage if indicated)

    Drug: Low-dose Aspirin

  • Placebo comparator
    Group-II: Placebo Group

    Participants receive a daily matching oral placebo starting from 8-16 weeks of gestation up to 36 weeks of gestation or until delivery, along with standard care (per-rectal progesterone and cervical cerclage if needed)

    Other: Placebo

Interventions

  • Participants take low-dose aspirin 75 mg orally once daily starting from 8-16 weeks of gestation until 36 weeks of gestation or delivery (whichever comes first), alongside routine clinical care (progesterone and cervical cerclage if indicated).

  • OtherPlacebo

    Participants take a daily matching oral placebo tablet starting from 8-16 weeks of gestation until 36 weeks of gestation or delivery, alongside routine clinical care (per-rectal progesterone and cervical cerclage if indicated).

06

What researchers measure

Primary outcomes

  1. Incidence of Recurrent Spontaneous Preterm Labor

    Proportion of participants who experience spontaneous onset of labor and delivery prior to completing 37 weeks (259 days) of gestation.

    Time frame: From enrollment (8-16 weeks of gestation) up to delivery (up to 42 weeks of gestation)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Feb 2027, 5 months later.

Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 5 months is below that.

Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2026
First posted
Aug 4, 2026
StartEst.
Aug 20, 2026
Primary completionEst.
Feb 15, 2027
CompletionEst.
Aug 15, 2027
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07745595
Lead sponsor
University of Health Sciences Lahore
Responsible party
Rida Tariq (Principle Investigator, University of Health Sciences Lahore) — Principal investigator
First posted
Aug 4, 2026
Start date
Aug 20, 2026 (estimated)
Primary completion
Feb 15, 2027 (estimated)
Completion
Aug 15, 2027 (estimated)
Last update
Aug 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Aspirin

Start the discussion