Preterm LaborNCT07745595
Low Dose Aspirin vs Placebo in Prevention of Recurrent Spontaneous Preterm Labour
A study testing Low-dose Aspirin in people with Preterm Labor and Premature Birth, run by University of Health Sciences Lahore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Labor, Premature Birth
- What is being tested?
- Low-dose Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age > 18 years.
- Singleton alive pregnancy.
- History of spontaneous preterm birth (22 to 37 weeks of gestation).
- Hemoglobin (Hb) > 10 g/dL.
- Absence of fetal anomalies on ultrasound examination.
Who cannot join
- Primigravida.
- Multiple pregnancy.
- Maternal age > 40 years.
- Known history of allergy or hypersensitivity to aspirin.
- Known maternal comorbidities including Pregnancy-Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), cardiac disease, HELLP syndrome, thrombocytopenia, thrombocytopathy, or epilepsy.
- Presence of a cervical cerclage prior to study enrollment.
About this study
Official title: Comparison of Low Dose Aspirin vs Placebo in the Prevention of Recurrent Spontaneous Preterm Labou
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.
- Conditions
- Preterm Labor, Premature Birth
- Being tested
- Low-dose Aspirin, Placebo
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose AspirinDrug
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).
PlaceboOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group-I: Aspirin Group | Experimental | 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) Receives: Drug: Low-dose Aspirin |
| Group-II: Placebo Group | Placebo comparator | 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment (8-16 weeks of gestation) up to delivery (up to 42 weeks of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rida Tariq, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745595
- Sponsor's protocol ID
- Exp143
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low Dose Aspirin vs Placebo in the Prevention of Recurrent Spontaneous Preterm Labou
- ClinicalTrials.gov ID
- NCT07745595
- Acronym / sponsor ID
- Exp143
- Conditions
- Preterm Labor, Premature Birth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-I: Aspirin Group | Experimental | Drug: Low-dose AspirinParticipants 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) |
| Group-II: Placebo Group | Placebo comparator | Other: PlaceboParticipants 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age > 18 years.
- Singleton alive pregnancy.
- History of spontaneous preterm birth (22 to 37 weeks of gestation).
- Hemoglobin (Hb) > 10 g/dL.
- Absence of fetal anomalies on ultrasound examination.
Key exclusion criteria (6 listed)
- Primigravida.
- Multiple pregnancy.
- Maternal age > 40 years.
- Known history of allergy or hypersensitivity to aspirin.
- Known maternal comorbidities including Pregnancy-Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), cardiac disease, HELLP syndrome, thrombocytopenia, thrombocytopathy, or epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose AspirinParticipants 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). | Drug | Group-I: Aspirin Group |
| PlaceboParticipants 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). | Other | Group-II: Placebo Group |
Primary outcome
Incidence of Recurrent Spontaneous Preterm Labor
Time frame: From enrollment (8-16 weeks of gestation) up to delivery (up to 42 weeks of gestation)
Proportion of participants who experience spontaneous onset of labor and delivery prior to completing 37 weeks (259 days) of gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose Aspirin in people with Preterm Labor and Premature Birth, run by University of Health Sciences Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Recurrent Spontaneous Preterm Labor (time frame: From enrollment (8-16 weeks of gestation) up to delivery (up to 42 weeks of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.