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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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), |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin tablet | Drug | group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia University | Shibīn al Kawm | Egypt |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
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All participants and investigators
| Placebo | Drug | group 2: oral placebo once daily at the same time with progesterone |
|
|
Neonatal birth weight Admission to NICU Neonatal complications
| 18 months |
| D000091642 | Urogenital Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |