Could Pre-operative Rectal Misoprostol Reduce Intra-opera... | NCT02509351

Studies
Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section?

NCT02509351

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Nov 10, 2016Estimated

Enrollment

280Actual

Phase

Phase 2Phase 3

Conditions

Postpartum Haemorrhage

Interventions

misoprostol
placeboo

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

May 2016

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

Oct 2015

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Jul 24, 2015

First Submission Date that Met QC Criteria

Jul 27, 2015

First Posted Date

Jul 28, 2015Estimated

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

Nov 9, 2016

Last Update Posted Date

Nov 10, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Misoprostol reduces the uterine bleeding after cesarean delivery without harmful effects on either mother or baby.
The aim of the this study is to address if there is any benefits 'regarding the intra-operative blood loss' from preoperative rectal administration of 400 mic of Misoprostol in addition to the routinely administrated 10 units of oxytocin

Detailed Description

Research question:

In women undergoing elective ceserean section, is preoperative 400 mic Misoprostol reduce intra-operative blood loss?

Research hypothesis:

pre-operative Misoprostol doesn't reduce intraoperative blood loss in women undergoing ceserean section

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

280Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
misoprostol	Experimental	women receiving pre-operative rectally administered 400 microgram misoprostol	Drug: misoprostol
placeboo	Active Comparator	women receiving placebo	Drug: placeboo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
misoprostol	Drug	400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section	misoprostol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
volume of intraoperative blood loss	volume of intraoperative blood loss will be measured in "cc" by a didcated nurse who will use separate suction sets to differentiate between blood and liquor	30 minute

Secondary Outcomes

Measure	Description	Time Frame
maternal mortality		6 months
mean measured blood loss		1, 2, and 24 h postpartum
placental retention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

38-41 weeks of amenorrhea
scheduled for elective lower segment cesarean section

Exclusion Criteria:

confirmed intrauterine fetal death
more than previous 2 ceserean sections
multiple pregnancy
antepartum haemorrhage
self-reported maternal heart disease
current diagnosis of severe malaria or acute bacterial infection

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helmy Dr metawe, MD	Ain Shams University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Ain Shams University		Cairo	Cairo Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

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