Ain shams university
Cairo, 11591, Egypt
NCT Number: NCT04807543
The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes.
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Notify Me20 year–35 year
Female
Interventional
Phase 2
Cairo, 11591, Egypt
After taking informed written consent, the recruited patients will be subjected to the following:
Abdominal examination:
The included patients were randomized using sealed opaque envelope method into one of two groups:
Group I (study group): in which 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume, intramuscular injection weekly) will be administered.
Group II (control group): in which an identical-appearing placebo (1 mL castor oil only) will be administered.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intramuscular injection weekly
intramuscular injection weekly
Time frame: 10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.)
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
Time frame: 10 to 12 weeks (interval in weeks from randomization to delivery)
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
Time frame: 1 week (from delivery to 1 week post Natal)
by Apgar score ,blood gases ,and labs
Ain Shams University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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