Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
Overview
- Phase
- Phase 4
- Intervention
- Aspirin tablet
- Conditions
- Preterm Birth
- Sponsor
- Menoufia University
- Enrollment
- 256
- Locations
- 1
- Primary Endpoint
- Number of participants who will deliver before 34 weeks gestation.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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).
Investigators
Mohamed Maher
Professor
Menoufia University
Eligibility Criteria
Inclusion Criteria
- •Women of any age
- •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
Arms & Interventions
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),
Intervention: Aspirin tablet
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).
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants who will deliver before 34 weeks gestation.
Time Frame: 18 month
Number of participants who have preterm delivery before 34 weeks gestation
Secondary Outcomes
- The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation(18 months)
- Neonatal outcomes(18 months)