Preterm Birth
Conditions
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).
Interventions
DRUGAspirin tablet
group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone
DRUGPlacebo
group 2: oral placebo once daily at the same time with progesterone
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All participants and investigators
Intervention model description
To detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who will deliver before 34 weeks gestation. | 18 month | Number of participants who have preterm delivery before 34 weeks gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation | 18 months | Number of participants who will deliver after 34w gestation and neonatal outcomes |
| Neonatal outcomes | 18 months | Neonatal birth weight Admission to NICU Neonatal complications |
Countries
Egypt
Outcome results
None listed