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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Drug: Aspirin tablet; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Shibīn Al Kawm, Egypt
    • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Progesterone with asprin; 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; group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone; Other Names: group 1 intervention
Placebo Comparator: Progesterone and 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).	Drug: Placebo; group 2: oral placebo once daily at the same time with progesterone; Other Names: group 2 intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who will deliver before 34 weeks gestation.	Number of participants who have preterm delivery before 34 weeks gestation	18 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Neonatal outcomes	Neonatal birth weight Admission to NICU Neonatal complications	18 months

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 3/2020/OBG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No