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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Preterm Birth

Intervention / Treatment
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* Drug: Aspirin tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of any age Any parity Healthy singleton pregnancy History suggestive of one or more previous PTB Current pregnancy (16-20) weeks gestation. Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone with asprin<br>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<br>* group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone<br>* Other names: group 1 intervention;|
| Placebo Comparator: Progesterone and placebo<br>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<br>* group 2: oral placebo once daily at the same time with progesterone<br>* Other names: group 2 intervention;|

What is the study measuring?
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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 |