Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

NCT ID: NCT03031353

Last Updated: 2018-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Misoprostol

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

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

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

Placebo

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

Group Type: ACTIVE_COMPARATOR

Placebos

Intervention Type: DRUG

placebos tablet will be given before elective Cesarean sections

Interventions

Misoprostol

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

Intervention Type: DRUG

Placebos

placebos tablet will be given before elective Cesarean sections

Intervention Type: DRUG

Other Intervention Names

Mesotac

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed El Kotb Abdel Fattah

Dr., Lecturer in obstertics and gynecology, Ain Shams University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed M kotb, MD

Role: CONTACT

ahmedmkotp@hotmail.com

01008681999 ext. 0020

ahmed DR kotb, MD

Role: CONTACT

ahmedmkotp@hotmail.com

1008681999 ext. 0020

Facility Contacts

ahmed kotb, MD

Role: primary

ahmedmkotp@hotmail.com

2001008681999

ebtihal dr eltaieb, MD

Role: backup

ahmedmkotp@hotmail.com

1004711414 ext. 0020

Other Identifiers

AinShamsU103

Identifier Type: -

Identifier Source: org_study_id