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

Preterm Birth Clinical Trial

— prematurity  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319834
• Other study ID #: 3/2020/OBG
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Drug:
• Aspirin tablet
group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone
• Placebo
group 2: oral placebo once daily at the same time with progesterone

Locations

Country	Name	City	State
Egypt	Menoufia University	Shibin Al Kawm

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who will deliver before 34 weeks gestation.	Number of participants who have preterm delivery before 34 weeks gestation	18 month
Secondary	The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation	Number of participants who will deliver after 34w gestation and neonatal outcomes	18 months
Secondary	Neonatal outcomes	Neonatal birth weight Admission to NICU Neonatal complications	18 months