NCT01033903

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

7.2 years

First QC Date

December 16, 2009

Last Update Submit

October 19, 2018

Conditions

Abortion, Spontaneous

Keywords

Abortion, SpontaneousRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • complete miscarriage

    10 days

Secondary Outcomes (1)

  • complete miscarriage

    17 days, 24 days, 31 days

Study Arms (2)

Misoprostol 800 micrograms intravaginally

EXPERIMENTAL
Drug: misoprostol

expectant managment

NO INTERVENTION

Interventions

misoprostolDRUG

800 micrograms intravaginally ONCE

Misoprostol 800 micrograms intravaginally

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • contraindications against misoprostol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Skane, Kvinnokliniken, University Hopsital MAS

Malmo, SE 20502, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 29072372DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2015

Study Completion

March 1, 2018

Last Updated

October 22, 2018

Record last verified: 2018-10

Locations

SE(1)