Optimal Treatment of Miscarriage | NCT01033903

Studies
Optimal Treatment of Miscarriage

NCT01033903

Sponsor

Region Skane

Status

Completed

Last Update Posted

Oct 22, 2018Actual

Enrollment

190Actual

Phase

Not Applicable

Conditions

Abortion, Spontaneous

Interventions

misoprostol

Countries

Sweden

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

Oct 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

Oct 1, 2008Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Mar 1, 2018Actual

First Submitted Date

Dec 16, 2009

First Submission Date that Met QC Criteria

Dec 16, 2009

First Posted Date

Dec 17, 2009Estimated

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

Oct 19, 2018

Last Update Posted Date

Oct 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Misoprostol 800 micrograms intravaginally	Experimental		Drug: misoprostol
expectant managment	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
misoprostol	Drug	800 micrograms intravaginally ONCE	Misoprostol 800 micrograms intravaginally

Measure	Description	Time Frame
complete miscarriage		10 days

Measure	Description	Time Frame
complete miscarriage		17 days, 24 days, 31 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

nonviable intrauterine pregnancy with retained gestational sac in the uterus
the embryo if visible 5 to 35 mm without a heart beat
vaginal bleeding
circulatory stable
hemoglobin at least 80 g/L

Exclusion Criteria:

contraindications against misoprostol

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Region Skane, Kvinnokliniken, University Hopsital MAS		Malmö		SE 20502	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29072372	Derived	Fernlund A, Jokubkiene L, Sladkevicius P, Valentin L. Misoprostol treatment vs expectant management in women with early non-viable pregnancy and vaginal bleeding: a pragmatic randomized controlled trial. Ultrasound Obstet Gynecol. 2018 Jan;51(1):24-32. doi: 10.1002/uog.18940. Epub 2017 Dec 5.

ID	Term
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