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Misoprostol for Management of Women With an Incomplete Miscarriage

NCT ID: NCT05088720

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-03-31

Brief Summary

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Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks gestation, that is, before fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated with abdominal pain and cramping. The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus.

Detailed Description

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the aim of the study is to evaluate 2 doses with misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment

Conditions

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Miscarriage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a double-blind placebo-controlled randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
a double-blind placebo-controlled randomized trial

Study Groups

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misoprostol 800 µg

received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Group Type EXPERIMENTAL

misoprostol 800 µg

Intervention Type DRUG

received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

misoprostol 400 µg

received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Group Type ACTIVE_COMPARATOR

misoprostol 400 µg

Intervention Type DRUG

received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Interventions

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misoprostol 800 µg

received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Intervention Type DRUG

misoprostol 400 µg

received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Intervention Type DRUG

Other Intervention Names

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Active Comparator

Eligibility Criteria

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Inclusion Criteria

* Women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation.
* No known allergy to misoprostol.
* Women who will be hemodynamically stable.
* Good access to emergency facilities

Exclusion Criteria

* Women with signs of severe infection ( fever \> 38°)
* Women with severe vaginal bleeding
* Women are known to have allergies to prostaglandins
* Severe abdominal pain requiring immediate intervention
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

A Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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aswu/354/7/19

Identifier Type: -

Identifier Source: org_study_id