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

Phase 4

Completed

• Conditions: Preterm Birth
• Interventions: Drug: Aspirin tablet; Drug: Placebo

• Registration Number: NCT05319834
• Lead Sponsor: Menoufia University

Brief 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).

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-31
• Study Start: 2022-04-01
• Study First Posted: 2022-04-08
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone with asprin	Aspirin tablet	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),
Progesterone and placebo	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).

Primary Outcome Measures

Name	Time	Method
Number of participants who will deliver before 34 weeks gestation.	18 month	Number of participants who have preterm delivery before 34 weeks gestation

Secondary Outcome Measures

Name	Time	Method
The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation	18 months	Number of participants who will deliver after 34w gestation and neonatal outcomes
Neonatal outcomes	18 months	Neonatal birth weight Admission to NICU Neonatal complications

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shibīn Al Kawm, Egypt