Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation

NCT03781674

Twin; Pregnancy, Affecting Fetus or Newborn

UNKNOWN NA

Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa

NCT03779451

Placenta Previa

UNKNOWN NA

High Versus Low Dose of Magnesium Sulfate as Initial Tocolytic Agent for Preterm Labour in Symptomatic Placenta Previa.

NCT04599868

Placenta Previa Bleeding

COMPLETED PHASE2

Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

NCT02338830

Premature Labour

COMPLETED PHASE4

Vaginal Progesterone Against a Second Attack of Antepartum Haemorrhage in Placenta Previa Women

NCT04725929

Placenta Previa

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All participants and investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Progesterone with asprin

The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1),

Group Type ACTIVE_COMPARATOR

Aspirin tablet

Intervention Type DRUG

group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone

Progesterone and placebo

vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

group 2: oral placebo once daily at the same time with progesterone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aspirin tablet

group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone

Intervention Type DRUG

Placebo

group 2: oral placebo once daily at the same time with progesterone

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

group 1 intervention group 2 intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Women of any age
2. Any parity
3. Healthy singleton pregnancy
4. History suggestive of one or more previous PTB
5. Current pregnancy (16-20) weeks gestation.

Exclusion Criteria

1. Multifetal pregnancy.
2. History of ante partum PROM.
3. Cervical Incompetence or current cervical cerclage.
4. Known fetal anomaly.
5. Hypertension requiring medications.
6. History of Thrombo-embolic disorders.
7. Known allergy to progesterone or asprin.
8. Known liver disease.
9. Established preterm labor
10. Short cervix

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No