Factors Influencing the Abortion Interval of Second-trime... | NCT01927822

Studies
Factors Influencing the Abortion Interval of Second-trimester Termination of Pregnancy Using Misoprostol

NCT01927822

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Jul 7, 2015Estimated

Enrollment

101Actual

Phase

Not provided

Conditions

Labor Induction

Interventions

Not provided

Countries

Taiwan

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

Jul 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

Aug 2013

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Aug 18, 2013

First Submission Date that Met QC Criteria

Aug 20, 2013

First Posted Date

Aug 23, 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

Jul 4, 2015

Last Update Posted Date

Jul 7, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sheng-Mou Hsiao, Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial HospitalPrincipal Investigator

Lead Sponsor

Far Eastern Memorial HospitalOTHER

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

This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.

Detailed Description

Misoprostol is the primary drug of choice for medical termination. It is not only cheap, but also stable at room temperature and easily available worldwide. It is indicated for the treatment of gastritis, but is widely used off-label for a variety of indications in the practice of obstetrics and gynecology, including medication abortion, induction of labor, and the treatment of postpartum hemorrhage. The optimal dosage and route of administration have not been well defined and vary with physicians. The potency of misoprostol's effect varies with dosage, route of administration and dosing interval; both maternal and fetal factors may, to certain extent, affect the abortion interval. This study aims to analyze the factors influencing the abortion interval of second-trimester termination of pregnancy using misoprostol.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnancy		Women who underwent termination of pregnancy at second trimester due to a variety of causes

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful termination rate by Cytotec.		1 week

Secondary Outcomes

Measure	Description	Time Frame
Factors affecting abortion interval by cytotec.	To identify the factors affecting termination interval Cox regression model.	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1.All female patients who were admitted for medical termination of second-trimester pregnancy

Exclusion Criteria:

1. Patients who are allergy to Cytotec.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

This is a single-center, retrospective chart review study. All female patients who were admitted for medical termination of second-trimester pregnancy from January 2008 to May 2013, at the Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital were recruited.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sheng-Mou Hsiao, MD	Far Eastern Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		New Taipei	Taiwan	220	Taiwan