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

NCT05319834 | Completed Phase 4 DMC

• 1 other identifier: 3/2020/OBG
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Number of participants who will deliver before 34 weeks gestation.

  Number of participants who have preterm delivery before 34 weeks gestation

  18 month

Secondary Outcomes (2)

• The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation

  18 months

• Neonatal outcomes

  18 months

Study Arms (2)

Progesterone with asprin

ACTIVE COMPARATOR

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),

Drug: Aspirin tablet

Progesterone and placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

Aspirin tablet DRUG

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

Also known as: group 1 intervention

Progesterone with asprin

Placebo DRUG

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

Also known as: group 2 intervention

Progesterone and placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Multifetal pregnancy.
• History of ante partum PROM.
• Cervical Incompetence or current cervical cerclage.
• Known fetal anomaly.
• Hypertension requiring medications.
• History of Thrombo-embolic disorders.
• Known allergy to progesterone or asprin.
• Known liver disease.
• Established preterm labor
• Short cervix

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Shibīn al Kawm, Egypt

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants and investigators
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 8, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)