NCT05319834

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Menoufia University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Preterm Birth

Interventions

Type	Name	Description
DRUG	Aspirin tablet	group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone
DRUG	Placebo	group 2: oral placebo once daily at the same time with progesterone

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-04-08
• Last updated: 2024-01-16

Locations

1 site across 1 country: Egypt