Misoprostol Before Caesarean Section
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-35
SponsorKafrelsheikh University
About this trial
The aim of our study is to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women with indication for elective caesarean section.
Age less than 35 years old.
Gestational age less than 38 weeks.
Gestational age will be confirmed by certain LMP or reliable early ultrasound measurement of crown-rump length.
Disqualifiers
Any obstetric disorders as preeclampsia and diabetes.
Fetus with oligohydramnios, intrauterine growth restriction.
Any contraindications to misoprostol like those with previous allergic reaction or hypersensitivity to prostaglandin hemorrhagic disorders, and severe anemia.
History of more than or equal 2 previous caesarean section.
Trial design
Design model
Parallel
Treatments tested in this trial
Misoprostol
Drugadministration of 100mg of misoprostol to evaluate the efficacy of Misoprostol before elective cesarean section in pregnant women with gestational age less than 38 weeks for preventing the occurrence of neonatal respiratory morbidity.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Misoprostol before elective cesarean section .Active comparator 1 intervention
Group B: Giving no treatment before elective caesarean section.Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
the incidence of Transient tachypnea of the newborn which defined by increase respiratory rate more than 60 cycle per minute in pregnant women with gestational age less than 38 weeks before elective cesarean section
Time frame
in the first 5 minute after delivery of fetus post operativeSponsors and contacts
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Source ClinicalTrials.gov