Efficacy of Misoprostol in Prevention of Neonatal Respiratory Morbidity in Parturient at Early Term Elective Caesarian Section

NCT04780412 | Unknown Phase 3

• 1 other identifier: Misoprostol
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Transient Tachypnea of the Newborn; Neonatal Respiratory Distress

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 hours after birth

Secondary Outcomes (1)

• Neonatal intensive care unit (NICU) admission

  up to 24 hours after birth

Study Arms (2)

Misoprostol Group

ACTIVE COMPARATOR

Drug: Misoprostol

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Misoprostol DRUG

Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.

Also known as: prostaglandin E1

Misoprostol Group

Placebo DRUG

Vaginal placebo pills given 90-120 minutes before an elective caesarian section.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University - Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Transient Tachypnea of the Newborn; Pulmonary Atelectasis

Interventions

Misoprostol; Alprostadil

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E; Fatty Acids, Monounsaturated

Study Officials

• Samar A. Kandeel

  Ain Shams University - Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 3, 2021
• Study Start: September 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

EG (1)