Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
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|ClinicalTrials.gov Identifier: NCT04780412|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Neonatal respiratory morbidities represent a common group of post natal complications including respiratory distress syndrome, transient tachypnea of newborn, and persistent pulmonary hypertension of newborn.
It is thought that preoperative vaginal misoprostol administration may decrease the incidence of neonatal respiratory morbidity especially transient tachypnea of newborn. And therefore, it may decrease the incidence of admission to neonatal intensive care units for respiratory causes.
|Condition or disease||Intervention/treatment||Phase|
|Transient Tachypnea of the Newborn Neonatal Respiratory Distress||Drug: Misoprostol Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
|Active Comparator: Misoprostol Group||
Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.
Other Name: prostaglandin E1
|Placebo Comparator: Placebo Group||
Vaginal placebo pills given 90-120 minutes before an elective caesarian section.
- incidence of neonatal respiratory morbidity (NRM) [ Time Frame: up to 24 hours after birth ]The incidence of neonatal respiratory morbidity, especially transient tachypnea of newborn, in early term neonates born to elective caesarian section.
- Neonatal intensive care unit (NICU) admission [ Time Frame: up to 24 hours after birth ]The incidence of the need for neonatal intensive care unit admission during the first ten days after delivery in early term neonates born to elective caesarian section.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780412
|Ain Shams University - Faculty of Medicine|
|Principal Investigator:||Samar A. Kandeel||Ain Shams University - Faculty of Medicine|