Preoperative vs. Postoperative Rectal Misoprostol in Cesa... | NCT03148717

Studies
Preoperative vs. Postoperative Rectal Misoprostol in Cesarean Section

NCT03148717

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Mar 22, 2018Actual

Enrollment

300Actual

Phase

Phase 2Phase 3

Conditions

Neonatal Outcome

Interventions

Misoprostol
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2017Actual

Primary Completion Date

Mar 2, 2018Actual

Completion Date

Mar 20, 2018Actual

First Submitted Date

Apr 29, 2017

First Submission Date that Met QC Criteria

May 10, 2017

First Posted Date

May 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2018

Last Update Posted Date

Mar 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective double-blind placebo-controlled randomized clinical trial will be conducted at Ain-Shams University Maternity Hospital from April 2017 till December 2017. Group 1 women, candidates for cesarean section, will receive preoperative rectal 400 microgram of misoprostol, and Group 2 women will receive postoperative rectal 400 microgram of misoprostol.

2017. 120 women candidate foe elective cesarean section will receive preoperative sublingual 400 microgram of misoprostol, and another 120 women will receive postoperative sublingual 400 microgram of misoprostol.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preoperative	Active Comparator	Group no.1 will receive preoperative rectal 400 microgram of misoprostol (Sigma) "2 tablets" and postoperative rectal placebo"2 tablets".	Drug: Misoprostol Other: Placebo
Postoperative	Active Comparator	Group no.2 will receive preoperative rectal placebo "2 tablets" and postoperative rectal 400 microgram of misoprostol (Sigma) " 2 tablets" .	Drug: Misoprostol Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	Cytotec	Postoperative Preoperative

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neonatal outcome	measured by APGAR score at 5 minutes	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
NICU admission	Number of neonates admitted to NICU within 24 hours.	24 hours
amount of blood loss		24 hours

Other Outcomes

Measure	Description	Time Frame
APGAR score at 1 minute		1 minute

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients candidate for cesarean section.
Full term pregnancies (GA 37- 42 Wks).
Age (18-40 yrs).
body mass index (BMI) (20-30(Kg/m2 .

Exclusion Criteia:

Contraindication to spinal anesthesia.
Blood dyscrasias.
Large fibroids.
Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
Emergency CS such as fetal distress
Extreme of BMI (<20 or >30 Kg/m2 ).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016595	Misoprostol

Ancestor Terms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids

Browse Leaves

Not provided

Browse Branches

Not provided