Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-06-01

Brief Summary

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The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion

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Detailed Description

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Conditions

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Abortion, Missed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hospital- based vaginal misoprostol

Group Type ACTIVE_COMPARATOR

vaginal misoprostol

Intervention Type DRUG

(800µgm.x 2 doses 3 hours).

extended low dose oral misoprostol

Group Type ACTIVE_COMPARATOR

buccal/sublingual misoprostol

Intervention Type DRUG

200 µgm.x4 hrs.x 6 doses

Interventions

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vaginal misoprostol

(800µgm.x 2 doses 3 hours).

Intervention Type DRUG

buccal/sublingual misoprostol

200 µgm.x4 hrs.x 6 doses

Intervention Type DRUG

Other Intervention Names

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buccal/sublingual misoprostol vaginal misoprostol

Eligibility Criteria

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Inclusion Criteria

* single dead fetus up-to 12 weeks.
* no low lying placenta
* no scarred uterus
* no or mild bleeding
* no evidence of infection
* accepting to participate in the study.

Exclusion Criteria

* Advanced hepatic diseases .
* Suspected molar pregnancy
* Ectopic pregnancy or pregnancy of unknown location
* Haemodynamically unstable with significant anaemia ie Hb\<10
* Uncontrolled severe asthma
* Chronic adrenal failure
* Known or suspected heart disease
* Glaucoma
* Haemoglobinopathies
* Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
* Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
* Patient living in remote areas with difficulty in accessing hospital

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No