NCT00797693

Brief Summary

The purpose of this study is to determine whether oral versus vaginal misoprostol is effective in termination of first trimester missed abortion and to compare between two different routes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
Last Updated

November 25, 2008

Status Verified

November 1, 2008

Enrollment Period

4 months

First QC Date

November 21, 2008

Last Update Submit

November 24, 2008

Conditions

Keywords

First trimestermissed abortionmisoprostolcervical ripeningoralvaginalfirst trimester missed abortion

Outcome Measures

Primary Outcomes (1)

  • Priming with misoprostol administered orally or vaginally three hours before surgical termination of first trimester missed abortion under general anesthesia facilitates cervical dilatation

    6 months

Secondary Outcomes (1)

  • Higher patient satisfaction for self administered oral misoprostol at home

    6 months

Study Arms (2)

Vaginal Misoprostol

EXPERIMENTAL

A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix

Drug: Misoprostol ( Cytotec) 200 microgram a tablet

Oral Misoprostol

EXPERIMENTAL

A drug is given vaginally and to compare this with an oral administration of the same drug to find it is effect on it is effect on the cervix

Drug: Misoprostol ( Cytotec) 200 microgram a tablet

Interventions

In this study, two arms we put under study ... and to find how far a single drug, Misoprostol, is effective to have changes on the cervix.

Also known as: PHARMACIA CORPORATION - Istanbul, serial number 022-00, 200 microgram a tablet
Oral MisoprostolVaginal Misoprostol

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients were cases of first trimester missed abortion.
  • They have uneventful history apart from history of slight vaginal bleeding, with normal general examination. Gynecological examination revealed no vaginal bleeding or discharge with no dilatation of the internal os with enlarged uterus.

You may not qualify if:

  • Cases with suspected or proven ectopic pregnancy, history of Caesarean section, medical diseases, a known hypersensitivity to a drug, smokers, patients with abnormal results of investigation and the presence of vaginal bleeding were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Teaching Hospital

Erbil, Hawler, 964, Iraq

Location

MeSH Terms

Conditions

Abortion, SpontaneousAbortion, Missed

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

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 25, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 25, 2008

Record last verified: 2008-11

Locations