Status:
COMPLETED
Comparative Study Between Vaginal Progesterone Alone or Combined With Aspirin in Prevention of Recurrent Preterm Birth
Lead Sponsor:
Menoufia University
Conditions:
Preterm Birth
Eligibility:
FEMALE
Phase:
PHASE4
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 o...
Eligibility Criteria
Inclusion
- Women of any age
- Any parity
- Healthy singleton pregnancy
- History suggestive of one or more previous PTB
- Current pregnancy (16-20) weeks gestation.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT05319834
Start Date
April 1 2022
End Date
December 31 2023
Last Update
January 16 2024
Active Locations (1)
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1
Menoufia University
Shibīn al Kawm, Egypt