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Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

Primary Purpose

Transient Tachypnea Newborn, Cesarean Delivery Affecting Fetus

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Placebos
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transient Tachypnea Newborn

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine, Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Misoprostol

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

The need for admission to neonatal intensive care unit (NICU)
Number of newborns admitted to NICU for respiratory morbidity

Secondary Outcome Measures

APGAR score below 6 at 5 minute
number of newborns delivered with APGAR score below 6 at 5 minutes

Full Information

First Posted
November 27, 2016
Last Updated
May 24, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03031353
Brief Title
Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity
Official Title
Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Tachypnea Newborn, Cesarean Delivery Affecting Fetus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Mesotac
Intervention Description
Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
placebos tablet will be given before elective Cesarean sections
Primary Outcome Measure Information:
Title
The need for admission to neonatal intensive care unit (NICU)
Description
Number of newborns admitted to NICU for respiratory morbidity
Time Frame
first 24 hours after delivery
Secondary Outcome Measure Information:
Title
APGAR score below 6 at 5 minute
Description
number of newborns delivered with APGAR score below 6 at 5 minutes
Time Frame
5 minutes after delivery
Other Pre-specified Outcome Measures:
Title
neonatal mortality
Description
number of neonates died from respiratory morbidity with one month of delivery
Time Frame
first month after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M kotb, MD
Phone
01008681999
Ext
0020
Email
ahmedmkotp@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed DR kotb, MD
Phone
1008681999
Ext
0020
Email
ahmedmkotp@hotmail.com
Facility Information:
Facility Name
Faculty of Medicine, Ain Shams University
City
Cairo
State/Province
Al Qahirah
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed kotb, MD
Phone
2001008681999
Email
ahmedmkotp@hotmail.com
First Name & Middle Initial & Last Name & Degree
ebtihal dr eltaieb, MD
Phone
1004711414
Ext
0020
Email
ahmedmkotp@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Misoprostol Before Elective Caesarean Section for Decreasing the Neonatal Respiratory Morbidity

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