- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780412
Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Ain Shams university - Faculty of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18 years or more.
- Early term singleton pregnancy.
- Elective caesarian section at (37 - 38+6) weeks of gestation.
- Any indication for lower uterine segment caesarian section other than labor (as malpresentations, severe preeclampsia, placenta previa with no previous bleeding attacks, Diabetes Mellitus, macrosomic fetus, non reassuring cardiotocogram (CTG), and fetal growth restriction).
- Informed written consent signed by the participating pregnant woman.
Exclusion Criteria:
- Women having any contraindication to Prostaglandin E1 as hypersensitivity, respiratory disease (especially bronchial asthma), or glaucoma.
- Any mental problems that block understanding of the nature and all the possible consequences of the procedure and the study.
- Pregnancies of known fetal diseases or chromosomal abnormalities.
- Non-singleton pregnancies.
- Emergency caesarian section as in ruptured membrane and women in labor pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Group
|
Vaginal placebo pills given 90-120 minutes before an elective caesarian section.
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Active Comparator: Misoprostol Group
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Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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up to 24 hours after birth
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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up to 24 hours after birth
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samar A. Kandeel, Ain Shams university - Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Signs and Symptoms, Respiratory
- Infant, Premature, Diseases
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Tachypnea
- Transient Tachypnea of the Newborn
- Physiological Effects of Drugs
- Vasodilator Agents
- Urological Agents
- Platelet Aggregation Inhibitors
- Gastrointestinal Agents
- Reproductive Control Agents
- Anti-Ulcer Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Misoprostol
- Alprostadil
Other Study ID Numbers
- Misoprostol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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