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Trial · NCT00671060

Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy

NCT00671060, Phase 3, Completed, Gynuity Health Projects; results first posted 2013-05-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy. Trials, record NCT00671060. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00671060

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
NCT number
NCT00671060
Status
Completed
Phases
Phase 3
Enrollment
153 participants, actual
Lead sponsor
Gynuity Health Projects
Conditions
Intrauterine Fetal Demise
Interventions
Misoprostol, Misoprostol
First posted
2008-05-02
Last updated
2013-05-08
Results first posted
2013-05-06

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySuccessful Expulsion of Fetus and Placenta Within 48 Hours48 hours

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYSuccessful Expulsion of Fetus and Placenta Within 48 Hours48 hours
One woman assigned to the 200μg arm was determined to be ineligible after enrollment due to a gestational age less than 14 weeks. She was not included in the analysis. One woman in the 100mcg arm was withdrawn from the study due to preeclampsia. She was included in the analysis as a failed induction.
participantsNUMBER

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Successful Expulsion of Fetus and Placenta Within 48 Hours200 Mcg60participants
Successful Expulsion of Fetus and Placenta Within 48 Hours100 Mcg47participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTED200 Mcg77
Overall StudySTARTED100 Mcg76
Overall StudyCOMPLETED200 Mcg76
Overall StudyCOMPLETED100 Mcg75
Overall StudyNOT COMPLETED200 Mcg1
Overall StudyNOT COMPLETED100 Mcg1

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherOther adverse eventSurgical and medical procedures200 Mcg1771
otherOther adverse eventSurgical and medical procedures100 Mcg0760

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortality200 Mcg
Total, all-cause mortality100 Mcg
Total, other adverse events200 Mcg177
Total, other adverse events100 Mcg076
Total, serious adverse events200 Mcg077
Total, serious adverse events100 Mcg076

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01FD003107MISOPROSTOL FOR TREATMENT OF FETAL DEATH AT 14-28 WEEKS PHASE IIIWINIKOFF, BEVERLYGYNUITY HEALTH PROJECTSFOOD AND DRUG ADMINISTRATION2007 to 2011

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
200 Mcg vs 100 Mcg: Successful Expulsion of Fetus and Placenta Within 48 HoursTrial comparisons
200 Mcg vs 100 Mcg: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00671060

GET https://conductscience.org/api/trials/v1/NCT00671060/registered