Comparing the Effect of Vaginal Misoprostol With Dinopros... | NCT00432588

Studies
Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies

NCT00432588

Sponsor

Hormozgan University of Medical Sciences

Status

Unknown status

Last Update Posted

Jun 1, 2007Estimated

Enrollment

Not provided

Phase

Phase 1Phase 2

Conditions

Preeclampsia
Fetal Death
Fetal Membranes, Premature Rupture

Interventions

misoprostol
dinoprostone

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

Feb 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 6, 2007

First Submission Date that Met QC Criteria

Feb 6, 2007

First Posted Date

Feb 8, 2007Estimated

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

May 31, 2007

Last Update Posted Date

Jun 1, 2007Estimated

Description Module

Brief Summary

Hypothesis (H0): Labor duration and obstetric complications are not significantly different in the three groups (misoprostol-dinoprostone-oxytocin).

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Term pregnancy
Singleton
Vertex
Bishop score below 6

Exclusion Criteria:

History of drug reaction
Medical disease
IUGR
Oligohydramnios
Vaginal bleeding
Fetal anomaly
Uterine scar

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mitra Ahmad Soltani	Hormozgan University of Medical Sciences	Principal Investigator
Minoo Rajaee Lari, Perinatologist - Obs and Gyn	Department of Obs and Gyn - HUMS	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shariaty Maternity Hospital		Tehran			Iran

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia
D005313	Fetal Death
D005322	Fetal Membranes, Premature Rupture

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
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
D015232	Dinoprostone

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
misoprostol	Drug
dinoprostone	Drug