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Vaginal Misoprostol In Management Of First Trimester Missed Abortion.

Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03148314
Enrollment
140
Registered
2017-05-11
Start date
2017-07-01
Completion date
2018-06-01
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, Missed

Brief summary

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

Interventions

DRUGvaginal misoprostol

(800µgm.x 2 doses 3 hours).

DRUGbuccal/sublingual misoprostol

200 µgm.x4 hrs.x 6 doses

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of patients with complete abortion (success rate).1 week

Secondary

MeasureTime frame
Number of misoprostol doses1 week
induction-abortion time1 week

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026