Misoprostol Versus Oxytocin for Prevention of Post Partum... | NCT01863706

Studies
Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

NCT01863706

Sponsor

Hormozgan University of Medical Sciences

Status

Completed

Last Update Posted

Mar 26, 2015Estimated

Enrollment

400Estimated

Phase

Phase 1

Conditions

Post Partum Hemorrhage

Interventions

Misoprostol
Oxytocin

Countries

Iran

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 2015

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 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

May 23, 2013

First Submission Date that Met QC Criteria

May 28, 2013

First Posted Date

May 29, 2013Estimated

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 25, 2015

Last Update Posted Date

Mar 26, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hamidreza Mahboobi, Dr, Hormozgan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Hormozgan University of Medical SciencesOTHER

Collaborators

Not provided

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

Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. The aim of this study is to compare the safety and efficacy of Oxytocin and misoprostol for prevention of PPH.

Detailed Description

In a double blind randomized controlled trial 400 pregnant women who has vaginal delivery at Shariati hospital are assigned into two groups either to receive 20 unite oxytocin in 1000cc ringer and 2 placebo tablet or 400mcg oral misoprostol and 2cc normal saline in 1000cc ringer.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Misoprostol	Experimental	400µg oral misoprostol	Drug: Misoprostol
Oxytocin	Active Comparator	20 IU oxytocin	Drug: Oxytocin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	400µg oral misoprostol	Misoprostol	Cytotec

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of bleeding	within 1 hours after delivery	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Hemoglobin decrease		24 hours
Hematocrite decrease		24 hours

Other Outcomes

Measure	Description	Time Frame
Side effects	Diarrhea, Vommiting, Fever, Chills	24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

were women with singleton pregnancy
with cephalic presentation
who had NVD spontaneously or by induction

Exclusion Criteria:

placenta previa
placental detachment
coagulation problems
previous CS
macrosomia
Polyhydramnios
and uncontrolled asthma

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Minoo Rajaei, Dr	Hormozgan University of Medical Sciences	Study Chair
Zohreh Shahboodaghi, Dr	Hormozgan University of Medical Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hormozgan University of Medical Sciences		Bandar Abbas	Hormozgan	097145-3388	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24734184	Derived	Rajaei M, Karimi S, Shahboodaghi Z, Mahboobi H, Khorgoei T, Rajaei F. Safety and efficacy of misoprostol versus oxytocin for the prevention of postpartum hemorrhage. J Pregnancy. 2014;2014:713879. doi: 10.1155/2014/713879. Epub 2014 Mar 5.

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

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