Back to resultsEfficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
Primary Purpose
Transient Tachypnea of the Newborn, Neonatal Respiratory Distress
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Transient Tachypnea of the Newborn
Eligibility Criteria
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.
Sites / Locations
- Ain Shams University - Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Misoprostol Group
Placebo Group
Arm Description
Outcomes
Primary Outcome Measures
incidence of neonatal respiratory morbidity (NRM)
The incidence of neonatal respiratory morbidity, especially transient tachypnea of newborn, in early term neonates born to elective caesarian section.
Secondary Outcome Measures
Neonatal intensive care unit (NICU) admission
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04780412
Brief Title
Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
Official Title
Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Tachypnea of the Newborn, Neonatal Respiratory Distress
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Misoprostol Group
Arm Type
Active Comparator
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
prostaglandin E1
Intervention Description
Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vaginal placebo pills given 90-120 minutes before an elective caesarian section.
Primary Outcome Measure Information:
Title
incidence of neonatal respiratory morbidity (NRM)
Description
The incidence of neonatal respiratory morbidity, especially transient tachypnea of newborn, in early term neonates born to elective caesarian section.
Time Frame
up to 24 hours after birth
Secondary Outcome Measure Information:
Title
Neonatal intensive care unit (NICU) admission
Description
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.
Time Frame
up to 24 hours after birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samar A. Kandeel
Organizational Affiliation
Ain Shams University - Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University - Faculty of Medicine
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section
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