Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

NCT03031353 | Unknown DMC

• 1 other identifier: AinShamsU103
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Neonatal respiratory distress may occur in either term or preterm newborns with a higher relative risk in preterm, and whether born vaginally or through caesarean section, but in a higher percentage after elective caesarean section whose rate is rising. Prostaglandins may be given about one hour before an elective caesarean section after excluding the presence of contraindication to their use to decrease the neonatal respiratory diseases and thus, the number of children who suffered from bronchopulmonary dysplasia that occurs frequently in children who had previously TTN will diminish.

Conditions

Transient Tachypnea Newborn; Cesarean Delivery Affecting Fetus

Outcome Measures

Primary Outcomes (1)

• The need for admission to neonatal intensive care unit (NICU)

  Number of newborns admitted to NICU for respiratory morbidity

  first 24 hours after delivery

Secondary Outcomes (1)

• APGAR score below 6 at 5 minute

  5 minutes after delivery

Other Outcomes (1)

• neonatal mortality

  first month after delivery

Study Arms (2)

Misoprostol

EXPERIMENTAL

After preparing for elective caesarean section, the pessary will be given containing the misoprostol medication 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized

Drug: Misoprostol

Placebo

ACTIVE COMPARATOR

After preparing for elective caesarean section, the pessary will be given containing placebo 1 hour before , women in the operating room, and the anaesthetic and surgical techniques will be standardized

Drug: Placebos

Interventions

Misoprostol DRUG

Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage

Also known as: Mesotac

Misoprostol

Placebos DRUG

placebos tablet will be given before elective Cesarean sections

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18 years or more.
• Term singleton pregnancy (38 - 38+6 weeks gestation).
• Planned for elective transverse lower segment caesarean section with an indication.

You may not qualify if:

• Women with history of significant cardiac disease, eclampsia, pre eclampsia, epilepsy, severe asthma, severe allergic condition, vascular disease, renal or hepatic disease.
• Women with contraindication to prostaglandins as Glucoma or known hypersensitivity to prostaglandins or specifically for misoprostol.
• Psychological problem or mental disease that renders the patient not able to understand the nature, scope, and sequences of the study.
• Pregnancies with known foetal malformation/s or chromosomal aberration.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Interventions

Misoprostol

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

Central Study Contacts

Ahmed M kotb, MD

CONTACT

01008681999; ahmedmkotp@hotmail.com

ahmed DR kotb, MD

CONTACT

1008681999; ahmedmkotp@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., Lecturer in obstertics and gynecology, Ain Shams University Hospital

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: January 25, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: May 29, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)