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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
Sponsor:
Information provided by (Responsible Party):
Samar Ali, Ain Shams University

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.


Condition or disease Intervention/treatment Phase
Transient Tachypnea of the Newborn Neonatal Respiratory Distress Drug: Misoprostol Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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


Arm Intervention/treatment
Active Comparator: Misoprostol Group Drug: Misoprostol
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 Drug: Placebo
Vaginal placebo pills given 90-120 minutes before an elective caesarian section.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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Egypt
Ain Shams University - Faculty of Medicine
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Samar A. Kandeel Ain Shams University - Faculty of Medicine
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Responsible Party: Samar Ali, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT04780412    
Other Study ID Numbers: Misoprostol
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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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
Additional relevant MeSH terms:
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Tachypnea
Respiratory Distress Syndrome, Newborn
Transient Tachypnea of the Newborn
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Alprostadil
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents