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

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menoufia University
• Treatments: Aspirin

Criteria

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